86 results on '"Bronsky E"'
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2. THE FAILED PROMISE OF LVO STROKE SCALES: A top choice hasn't emerged, and their use may have negative impacts elsewhere
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Bronsky, E. Stein and Angelidis, Matthew
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Stroke (Disease) -- Care and treatment ,Government - Abstract
Over the past few years, the landscape of acute ischemic stroke (AIS) treatment has undergone a significant transformation. It has evolved from TPA as the only viable emergent intervention into [...]
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- 2020
3. ONCE-DAILY (OD) TRIAMCINOLONE ACETONIDE AQUEOUS NASAL SPRAY (TA-AQ) CONTROLS SEASONAL ALLERGIC RHINITIS MORE EFFECTIVELY THAN LORATADINE (LO): 532
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Bronsky, E., Goodman, D., and Lim, J.
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- 1997
4. EFFICACY AND SAFETY OF EBASTINE 20MG ONCE DAILY (AM) IN THE TREATMENT OF PERENNIAL ALLERGIC RHINITIS (PAR) : WS 120
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Bronsky, E. A.
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- 1996
5. Corticosteroid-sparing effect of azelastine in the management of bronchial asthma.
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Busse, W W, Middleton, E, Storms, W, Dockhorn, R J, Chu, T J, Grossman, J, Weiler, J M, Bronsky, E A, Mansfield, L E, Bell, T D, Hemsworth, G R, Perhach, J L, DʼEletto, T A, and Dam, A
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- 1996
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6. Intravenous Low-Dose Ketamine Provides Greater Pain Control Compared to Fentanyl in a Civilian Prehospital Trauma System: A Propensity Matched Analysis.
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Bronsky, E. Stein, Koola, Catherine, Orlando, Alessandro, Redmond, Diane, D'Huyvetter, Cecile, Sieracki, Heather, Tanner, Allen, Fowler, Ray, Mains, Charles, and Bar-Or, David
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FENTANYL ,BLOOD pressure ,CHI-squared test ,COMPARATIVE studies ,EMERGENCY medical services ,EMERGENCY medicine ,FISHER exact test ,HEART beat ,INTRAVENOUS therapy ,KETAMINE ,SCIENTIFIC observation ,PAIN ,PATIENTS ,PROBABILITY theory ,RESPIRATORY measurements ,T-test (Statistics) ,VITAL signs ,PAIN management ,DATA analysis ,PAIN measurement ,TREATMENT effectiveness ,RETROSPECTIVE studies ,DATA analysis software ,ADVERSE health care events ,DESCRIPTIVE statistics ,GLASGOW Coma Scale ,THERAPEUTICS - Abstract
Objective: A few studies report comparable analgesic efficacy between low-dose ketamine and opioids such as morphine or fentanyl; however, limited research has explored the safety and effectiveness of intravenous low-dose ketamine as a primary analgesic in a civilian prehospital setting. The objective of this study is to compare pain control between low-dose ketamine and fentanyl when administered intravenously (IV) for the indication of severe pain. Methods: This was a retrospective, observational review of prehospital adult patients (≥18 years) who presented with severe pain (numeric rating scale, 7-10) and were treated solely with either low-dose ketamine IV or fentanyl IV between January 1, 2014 and December 31, 2016. Propensity matched analysis was performed adjusting for all baseline variables with p ≤ 0.10 and for baseline pain score to match ketamine and fentanyl patients on a one-to-one ratio. The primary outcome was change in pain score from baseline to after treatment and evaluated with a paired t-test. Secondary outcomes were changes in vital signs and Glasgow coma scale (GCS) from baseline to after treatment, as well as incidence of clinically significant adverse events (AEs); AEs were followed from scene arrival through emergency department discharge. Results: Propensity matched analysis produced 79 matched pairs. Ketamine IV patients, receiving a mean (SD) dose of 0.3 (0.1) mg/kg, showed a significantly larger mean decrease in pain after treatment, compared to the fentanyl IV patients (−5.5 (3.1) vs. −2.5 (2.4), p < 0.001). A significantly greater proportion of patients receiving ketamine IV achieved at least a 50% reduction in pain compared to those receiving fentanyl IV (67% vs. 19%, p < 0.001), marking 52 ketamine IV patients as responders to treatment. Vital signs demonstrated a nonsignificant decrease in blood pressure, respiratory rate, heart rate, and GCS. No clinically significant AEs were reported for patients receiving ketamine IV. Conclusion: The significant reduction in pain, significantly high proportion of ketamine responders, and the lack of clinically significant AEs characterizing patients receiving low-dose ketamine IV compared to fentanyl IV, all provide further support for its use as an effective prehospital analgesic. Level of Evidence: Level III, therapeutic. [ABSTRACT FROM AUTHOR]
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- 2019
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7. CARES: A COMMUNITY-WIDE COLLABORATION IDENTIFIES SUPER-UTILIZERS AND REDUCES THEIR 9-1-1 CALL, EMERGENCY DEPARTMENT, AND HOSPITAL VISIT RATES.
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Bronsky, E. Stein, McGraw, Constance, Johnson, Robin, Giordano, Kristin, Orlando, Alessandro, and Bar-Or, David
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CHI-squared test ,EMERGENCY medical services ,SCIENTIFIC observation ,STATISTICAL hypothesis testing ,RETROSPECTIVE studies ,DATA analysis software ,DESCRIPTIVE statistics ,MANN Whitney U Test - Abstract
Background: A subset of individuals who inefficiently and frequently use emergency department (ED) services are called "super-utilizers."Our healthcare system is fragmented and complex, making it difficult for providers to identify super-utilizers and address their wide range of health issues. Objective: The objective of our study was to evaluate a novel community-wide collaboration program called CARES (Community Assistance Referral and Education Services) designed to identify super-utilizers through local partnering organizations. CARES assists patients in developing their personal health andwellness goals, and navigates them away from 9-1-1 calls, emergency room visits, and hospital admissions, and toward more appropriate resources over 90 days. Methods: This was a retrospective observational analysis of the CARES program. Data were collected from March 2013 to December 2015. The study population included: enrolled adults with non-compliance of medication or treatment; behavioral health problems; multiple 9-1-1 responses in a short period of time; three or more ED visits within six months; patients with multiple hospital admissions. Adults who were outside of the study period or had missing outcome information were excluded. The primary outcomes of this study were the median rate of 9-1-1 calls/month/person, ED and hospital visits/month/person. Wilcoxon rank-sum tests were used to compare changes between pre- vs. postenrollment for each subject. Results: A total of 441 subjects were included in this study. The majority of patients (64%) were female, 64% were white, and the median (IQR) age was 48 (35-62) years old. A total of 51% were on Medicaid and 69% identified behavioral health issues as their barriers to optimal health care. Between pre- and post-enrollment periods, the median (IQR) monthly rate of 9-1-1 calls, ED visits, and hospital admissions significantly decreased by 0.26 (-0.06, 0.90), 0.25 (-0.08, 0.71), and 0.18 (0.04, 0.53) (p < 0.001 for all). Conclusions: When health systems in a geographic area share data, they are better able to recognize patterns of overuse, and address them properly. This study demonstrated that a collaborative 90-day intervention identifying super-utilizers reduced the monthly rate of 9-1-1 calls, ED visits, and hospital admissions. [ABSTRACT FROM AUTHOR]
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- 2017
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8. ONCE-DAILY DOSING WITH MOMETASONE FUROATE (MF) IS EFFECTIVE IN PATIENTS WITH MODERATE PERSISTENT ASTHMA WHO REQUIRE TREATMENT WITH INHALED CORTICOSTEROIDS
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Noonan, M, Bronsky, E A., Ramsdell, J W., Bensch, G Wm, and Lutsky, B N.
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Mometasone -- Dosage and administration ,Asthma -- Drug therapy ,Health ,Drug therapy ,Dosage and administration - Abstract
Purpose: To compare several once-daily (QD) dosing strategies of MF administered by dry powder inhaler (DPI) and evaluate the effectiveness of QD dosing versus twice-daily (BID) dosing. Methods: Following MF [...]
- Published
- 1999
9. COMMUNICATION CRISIS: Prevent medical errors & unnecessary spending with effective communication.
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Woodson, James and Bronsky, E. Stein
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- 2018
10. Oral montelukast compared with inhaled salmeterol to prevent exercise-induced bronchoconstriction. A randomized, double-blind trial. Exercise Study Group.
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Edelman JM, Turpin JA, Bronsky EA, Grossman J, Kemp JP, Ghannam AF, DeLucca PT, Gormley GJ, Pearlman DS, Exercise Study Group, Edelman, J M, Turpin, J A, Bronsky, E A, Grossman, J, Kemp, J P, Ghannam, A F, DeLucca, P T, Gormley, G J, and Pearlman, D S
- Abstract
Background: Montelukast, an oral, once-daily leukotriene receptor antagonist, provides protection against exercise-induced bronchoconstriction.Objective: To evaluate the effect of 8 weeks of therapy with salmeterol aerosol or montelukast on exercise-induced bronchoconstriction in adults with asthma.Design: 8-week multicenter, randomized, double-blind study.Setting: 17 asthma treatment centers in the United States.Patients: 191 adults with asthma who had documented exercise-induced bronchoconstriction.Intervention: Qualified patients were randomly assigned to double-blind treatment with montelukast (10 mg once in the evening) or salmeterol (50 microg [2 puffs] twice daily).Measurements: Changes in pre-exercise and postexercise challenge values; percentage inhibition in the maximal percentage decrease in FEV1; the area above the FEV1-time curve; and time to recovery of FEV1 at days 1 to 3, week 4, and week 8 of treatment.Results: By day 3, similar and statistically significant reductions in maximal percentage decrease in FEV1 were seen with both therapies. Sustained improvement occurred in the montelukast group at weeks 4 and 8; at these time points, the bronchoprotective effect of salmeterol decreased significantly. At week 8, the percentage inhibition in the maximal percentage decrease in FEV1 was 57.2% in the montelukast group and 33.0% in the salmeterol group (P = 0.002). By week 8, 67% of patients receiving montelukast and 46% of patients receiving salmeterol had a maximal percentage decrease in FEV1 of less than 20%.Conclusions: The bronchoprotective effect of montelukast was maintained throughout 8 weeks of study. In contrast, significant loss of bronchoprotection at weeks 4 and 8 was seen with salmeterol. Long-term administration of montelukast provided consistent inhibition of exercise-induced bronchoconstriction at the end of the 8-week dosing interval without tolerance. [ABSTRACT FROM AUTHOR]- Published
- 2000
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11. Increased urinary excretion of LTE4 after exercise and attenuation of exercise-induced bronchospasm by montelukast, a cysteinyl leukotriene receptor antagonist.
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Reiss, Theodore F, Hill, James B., Harman, Eloise, Ji Zhang, Tanaka, Wesley K., Bronsky, Edwin, Guerreiro, Debra, Hendeles, Leslie, Reiss, T F, Hill, J B, Harman, E, Zhang, J, Tanaka, W K, Bronsky, E, Guerreiro, D, and Hendeles, L
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ACETIC acid ,COMPARATIVE studies ,CROSSOVER trials ,EXERCISE ,EXERCISE tests ,LEUKOTRIENES ,QUINOLINE ,RESEARCH funding ,STATISTICAL sampling ,EXERCISE-induced asthma ,RANDOMIZED controlled trials ,VITAL capacity (Respiration) ,BLIND experiment ,LEUKOTRIENE antagonists ,THERAPEUTICS - Abstract
Background: A study was undertaken to determine whether montelukast, a new potent cysteinyl leukotriene receptor antagonist, attenuates exercise-induced bronchoconstriction. The relationship between the urinary excretion of LTE4 and exercise-induced bronchoconstriction was also investigated.Methods: Nineteen non-smoking asthmatic patients with a forced expiratory volume in one second (FEV1) of > or = 65% of the predicted value and a reproducible fall in FEV1 after exercise of at least 20% were enrolled. Subjects received placebo and montelukast 100 mg once daily in the evening or 50 mg twice daily, each for two days, in a three-period, randomised, double blind, crossover design. In the evening, approximately 20-24 hours after the once daily dose or 12 hours after the twice daily dose, a standardised exercise challenge was performed. Data from 14 patients were available for complete analysis.Results: The mean (SD) maximal percentage decrease in FEV1 after exercise was 29.6 (16.0), 17.1 (8.2), and 14.0 (9.4) for placebo, once daily, and twice daily regimens, respectively. The mean (95% CI) percentage protection was 37 (15 to 59) for the group who received 50 mg twice daily and 50 (31 to 69) for those who received 100 mg once daily. Active treatments were not different from each other. The mean (SD) plasma concentrations of montelukast were higher after the twice daily regimen (1.27 (0.81) microgram/ml) than after the once daily regimen (0.12 (0.09) microgram/ml); there was no correlation between the percentage protection against exercise-induced bronchoconstriction and plasma concentrations. After exercise urinary excretion of LTE4 increased significantly during placebo treatment (from 34.3 to 73.7 pg/mg creatinine; p < 0.05) but did not correlate with the extent of exercise-induced bronchoconstriction.Conclusions: Montelukast protects similarly against exercise-induced bronchoconstriction between plasma concentrations of 0.12 and 1.27 micrograms/ml. The increase in the urinary excretion of LTE4 after exercise and the protection from exercise-induced bronchoconstriction with a cysteinyl leukotriene receptor antagonist provide further evidence of the role of leukotrienes in the pathogenesis of exercise-induced bronchoconstriction. [ABSTRACT FROM AUTHOR]- Published
- 1997
12. Oral montelukast was better than inhaled salmeterol for reducing exercise induced bronchoconstriction in adults with asthma.
- Author
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Edelman, J. M., Turpin, J. A., and Bronsky, E. A.
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- 2000
13. 436 A study of procaterol hydrochloride and isoproterenol aerosol in pediatric outpatients with asthma
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Segal, A, Kemp, J, Bock, S, Nathan, R, Shapiro, G, Siegel, S, Wolfe, J, Spangler, D, Pinnas, J, Mendelson, L, Grossman, J, Chervinsky, P, Bronsky, E, and Cummins, L
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- 1988
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14. 464 Fluticasone propionate (FP) aerosol in asthma
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Chervinsky, P, Bronsky, E, Dockhorn, R, LaForce, C, Noonan, M, Pearlman, D, Pleskow, W, Seltzer, J, Schoenwetter, W, van As, A, Webb, R, Fluticasone Study Group, and Dartmouth, N.
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- 1991
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15. 461 Effect of beclomethasone and theophylline on nonspecific bronchial hyperresponsiveness (BHR) in asthmatics exposed and not exposed to allergens to which they are sensitive
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Areson, J, Nelson, HS, Pearlman, D, Nathan, R, Bronsky, E, and Bell, T
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- 1991
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16. 61 Fluticasone propionate once daily is as effective as beclomethasone dipropionate twice daily for perennial allergic rhinitis
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van As, A, Bronsky, E, Chervinsky, P, Dockhorn, R, Furukawa, C, Grossman, J, Lockey, R, Lumry, W, Meltzer, E, Nathan, R, Seltzer, J, van Bavel, J, and Rogenes, P
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- 1991
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17. 1009 Efficacy and safety of fexofenadine HCl in fall seasonal allergic rhinitis
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Tinkelman, D., Falliers, C., Bronsky, E., Kaiser, H., and Mason, J.
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- 1996
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18. 697 Fluticasone propionate 50MCG BID and 100MCG BID improves functional status and decreases sleep disturbances in children with asthma
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Mahajan, P., Okamoto, L., Bosh, T., Kellerman, D., Baker, K., and Bronsky, E.
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- 1996
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19. PRODUCTION OF TOLERANCE IN IMMUNIZED MICE AND THE EFFECTS OF IMMUNOSUPPRESSION.
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Bronsky, E
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- 1966
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20. Out-of-Hospital Ketamine: Indications for Use, Patient Outcomes, and Associated Mortality.
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Fernandez AR, Bourn SS, Crowe RP, Bronsky ES, Scheppke KA, Antevy P, and Myers JB
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- Adolescent, Adult, Aged, Aged, 80 and over, Child, Female, Humans, Male, Middle Aged, Retrospective Studies, Anesthetics, Dissociative administration & dosage, Emergency Medical Services, Ketamine administration & dosage
- Abstract
Study Objective: To describe out-of-hospital ketamine use, patient outcomes, and the potential contribution of ketamine to patient death., Methods: We retrospectively evaluated consecutive occurrences of out-of-hospital ketamine administration from January 1, 2019 to December 31, 2019 reported to the national ESO Data Collaborative (Austin, TX), a consortium of 1,322 emergency medical service agencies distributed throughout the United States. We descriptively assessed indications for ketamine administration, dosing, route, transport disposition, hypoxia, hypercapnia, and mortality. We reviewed cases involving patient death to determine whether ketamine could be excluded as a potential contributing factor., Results: Indications for out-of-hospital ketamine administrations in our 11,291 patients were trauma/pain (49%; n=5,575), altered mental status/behavioral indications (34%; n=3,795), cardiovascular/pulmonary indications (13%; n=1,454), seizure (2%; n=248), and other (2%; n=219). The highest median dose was for altered mental status/behavioral indications at 3.7 mg/kg (interquartile range, 2.2 to 4.4 mg/kg). Over 99% of patients (n=11,274) were transported to a hospital. Following ketamine administration, hypoxia and hypercapnia were documented in 8.4% (n=897) and 17.2% (n=1,311) of patients, respectively. Eight on-scene and 120 in-hospital deaths were reviewed. Ketamine could not be excluded as a contributing factor in 2 on-scene deaths, representing 0.02% (95% confidence interval 0.00% to 0.07%) of those who received out-of-hospital ketamine. Among those with in-hospital data, ketamine could not be excluded as a contributing factor in 6 deaths (0.3%; 95% confidence interval 0.1% to 0.7%)., Conclusion: In this large sample, out-of-hospital ketamine was administered for a variety of indications. Patient mortality was rare. Ketamine could not be ruled out as a contributing factor in 8 deaths, representing 0.07% of those who received ketamine., (Copyright © 2021 American College of Emergency Physicians. Published by Elsevier Inc. All rights reserved.)
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- 2021
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21. The relationship of large city out-of-hospital cardiac arrests and the prevalence of COVID-19.
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McVaney KE, Pepe PE, Maloney LM, Bronsky ES, Crowe RP, Augustine JJ, Gilliam SO, Asaeda GH, Eckstein M, Mattu A, Fumagalli R, Aufderheide TP, and Osterholm MT
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Background: Though variable, many major metropolitan cities reported profound and unprecedented increases in out-of-hospital cardiac arrest (OHCA) in early 2020. This study examined the relative magnitude of those increases and their relationship to COVID-19 prevalence., Methods: EMS (9-1-1 system) medical directors for 50 of the largest U.S. cities agreed to provide the aggregate, de-identified, pre-existing monthly tallies of OHCA among adults (age >18 years) occurring between January and June 2020 within their respective jurisdictions. Identical comparison data were also provided for corresponding time periods in 2018 and 2019. Equivalent data were obtained from the largest cities in Italy, United Kingdom and France, as well as Perth, Australia and Auckland, New Zealand., Findings: Significant OHCA escalations generally paralleled local prevalence of COVID-19. During April, most U.S. cities (34/50) had >20% increases in OHCA versus 2018-2019 which reflected high local COVID-19 prevalence. Thirteen observed 1·5-fold increases in OHCA and three COVID-19 epicenters had >100% increases (2·5-fold in New York City). Conversely, cities with lesser COVID-19 impact observed unchanged (or even diminished) OHCA numbers. Altogether ( n = 50), on average, OHCA cases/city rose 59% during April ( p = 0·03). By June, however, after mitigating COVID-19 spread, cities with the highest OHCA escalations returned to (or approached) pre-COVID OHCA numbers while cities minimally affected by COVID-19 during April (and not experiencing OHCA increases), then had marked OHCA escalations when COVID-19 began to surge locally. European, Australian, and New Zealand cities mirrored the U.S. experience., Interpretation: Most metropolitan cities experienced profound escalations of OHCA generally paralleling local prevalence of COVID-19. Most of these patients were pronounced dead without COVID-19 testing., Funding: No funding was involved. Cities provided de-identified aggregate data collected routinely for standard quality assurance functions., Competing Interests: None of the authors or contributing investigators have any conflict of interest with respect to this observational, epidemiological, population-based cross-sectional research study which was based on routinely-collected public agency data sets., (© 2021 The Authors.)
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- 2021
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22. Once-daily desloratadine improves the signs and symptoms of chronic idiopathic urticaria: a randomized, double-blind, placebo-controlled study.
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Ring J, Hein R, Gauger A, Bronsky E, and Miller B
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- Adolescent, Adult, Aged, Cholinergic Antagonists adverse effects, Chronic Disease, Dizziness chemically induced, Double-Blind Method, Drug Administration Schedule, Fatigue chemically induced, Female, Headache chemically induced, Humans, Loratadine adverse effects, Male, Middle Aged, Pharyngitis chemically induced, Pruritus prevention & control, Respiratory Tract Infections chemically induced, Treatment Outcome, Urticaria pathology, Virus Diseases chemically induced, Cholinergic Antagonists therapeutic use, Loratadine analogs & derivatives, Loratadine therapeutic use, Urticaria drug therapy
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Background: Chronic idiopathic urticaria (CIU) is the most common type of chronic urticaria, and pruritus is the most prominent symptom. Antihistamines are the first-line treatment for CIU. Sedation and anticholinergic adverse effects are often experienced with the first-generation antihistamines and there is a risk of cardiovascular adverse effects and drug interactions with some second-generation agents. Hence, new treatment options are needed. Desloratadine is a new, potent, nonsedating antihistamine that has an excellent cardiovascular safety profile., Methods: This was a multicenter, randomized, double-blind, placebo-controlled study designed to determine the efficacy and safety of desloratadine in the treatment of moderate-to-severe CIU. A total of 190 patients, aged 12-79 years, with at least a 6-week history of CIU and who were currently experiencing a flare of at least moderate severity, were randomly assigned to therapy with desloratadine 5 mg or placebo once daily for 6 weeks. Twice daily, patients rated the severity of CIU symptoms (pruritus, number of hives, and size of largest hive), as well as the impact of CIU symptoms on sleep and daily activity. Patients and investigators jointly evaluated therapeutic response and overall condition. Safety evaluations included the incidence of treatment-emergent adverse events, discontinuations due to adverse events, and changes from baseline in vital signs, laboratory parameters, and ECG intervals., Results: Desloratadine was superior to placebo in controlling pruritus and total symptoms after the first dose and maintained this superiority to the end of the study. Measures of sleep, daily activity, therapeutic response, and global CIU status were also significantly better with desloratadine after the first dose; these clinical benefits were also maintained throughout the 6-week study. No significant adverse events occured., Conclusions: Desloratadine 5 mg daily is a safe and effective treatment for CIU with significant benefits within 24 h and maintained through the treatment period.
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- 2001
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23. Clinical comparability of ventolin formulated with hydrofluoroalkane or conventional chlorofluorocarbon propellants in children with asthma.
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Shapiro G, Bronsky E, Murray A, Barnhart F, VanderMeer A, and Reisner C
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- Aerosols, Alkanes, Chemistry, Pharmaceutical, Child, Child, Preschool, Chlorofluorocarbons, Double-Blind Method, Female, Humans, Male, Peak Expiratory Flow Rate drug effects, Albuterol administration & dosage, Asthma drug therapy, Bronchodilator Agents administration & dosage
- Abstract
Background: Aerosolized asthma medications with chlorofluorocarbon (CFC) propellants are being phased out because of environmental concerns about the ozone layer. Medications are being reformulated with non-ozone-depleting propellants., Objective: To evaluate the clinical comparability of albuterol sulfate formulated in a new hydrofluoroalkane-134a (HFA) propellant (Ventolin HFA Inhalation Aerosol), and conventional CFC-containing albuterol (Ventolin Inhalation Aerosol) in children with asthma., Design: Randomized, double-blind, placebo-controlled 2-week clinical trial with a 1- to 2-week run-in period. During the run-in, patients took Ventolin CFC as needed. Patients (n = 135) aged 4 to 11 years with asthma then were assigned randomly to treatment with Ventolin HFA, Ventolin CFC, or placebo administered 4 times daily via metered-dose inhaler for 2 weeks. All patients were allowed rescue albuterol use in matching propellant as needed for relief of breakthrough symptoms. The main outcome measure was the mean percentage of predicted peak expiratory flow (PEF) after the morning dose of study drug on day 1 and after 2 weeks as assessed by results of 6-hour serial tests., Results: At day 1, the mean (+/- SE) percentage of predicted PEF increased postdose by 14% (+/- 1%) in the Ventolin HFA group and 13% (+/- 1%) in the Ventolin CFC group compared with 6% (+/- 2%) in the placebo group (P=.006). At week 2, mean postdose increases were 11% (+/- 1%) in the Ventolin HFA and CFC groups compared with 5% (+/- 1%) in the placebo group (P<.001). There were no significant differences between the Ventolin HFA and CFC groups in postdose increases in pulmonary function, time to onset of response, duration of response, or peak effects. Safety profiles were similar among the 3 groups., Conclusion: Ventolin HFA is clinically comparable to Ventolin formulated with the conventional CFC-containing propellant when administered to children with asthma. Arch Pediatr Adolesc Med. 2000;154:1219-1225.
- Published
- 2000
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24. Inhaled mometasone furoate reduces oral prednisone requirements while improving respiratory function and health-related quality of life in patients with severe persistent asthma.
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Fish JE, Karpel JP, Craig TJ, Bensch GW, Noonan M, Webb DR, Silverman B, Schenkel EJ, Rooklin AR, Ramsdell JW, Nathan R, Leflein JG, Grossman J, Graft DF, Gower RG, Garay SM, Frigas E, Degraff AC, Bronsky EA, Bernstein DI, Berger W, Shneyer L, Nolop KB, and Harrison JE
- Subjects
- Administration, Inhalation, Administration, Oral, Adolescent, Adult, Aged, Anti-Asthmatic Agents administration & dosage, Anti-Inflammatory Agents administration & dosage, Asthma physiopathology, Consumer Product Safety, Double-Blind Method, Female, Glucocorticoids administration & dosage, Health Status, Humans, Male, Middle Aged, Mometasone Furoate, Prednisone administration & dosage, Pregnadienediols administration & dosage, Respiratory Function Tests, Anti-Asthmatic Agents therapeutic use, Anti-Inflammatory Agents therapeutic use, Asthma drug therapy, Glucocorticoids therapeutic use, Prednisone therapeutic use, Pregnadienediols therapeutic use, Quality of Life
- Abstract
Background: Inhaled corticosteroid therapy in severe persistent asthma has been shown to reduce or eliminate oral corticosteroid (OCS) use while retaining effective asthma control., Objective: We sought to evaluate the ability of mometasone furoate (MF) delivered by means of dry powder inhaler to reduce daily oral prednisone requirements in OCS-dependent patients with severe persistent asthma., Methods: We performed a 12-week, double-blind, placebocontrolled trial (21 centers, 132 patients) comparing 2 doses of MF (400 and 800 microg administered twice daily) with placebo, followed by a 9-month open-label phase in which 128 patients received treatment with MF., Results: At the endpoint of the double-blind trial, MF 400 and 800 mg twice daily reduced daily OCS requirements by 46.0% and 23.9%, respectively, whereas placebo increased OCS requirements by 164.4% (P <.01). Oral steroids were eliminated in 40%, 37%, and 0% of patients in the MF 400 and 800 mg twice daily and placebo groups, respectively. Pulmonary function and quality of life significantly increased for MF-treated patients. Further reductions in OCS requirements were achieved with long-term MF treatment in the open-label phase., Conclusion: MF inhaled orally as a dry powder is an effective alternative to systemic corticosteroids in patients with severe persistent asthma.
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- 2000
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25. Absence of growth retardation in children with perennial allergic rhinitis after one year of treatment with mometasone furoate aqueous nasal spray.
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Schenkel EJ, Skoner DP, Bronsky EA, Miller SD, Pearlman DS, Rooklin A, Rosen JP, Ruff ME, Vandewalker ML, Wanderer A, Damaraju CV, Nolop KB, and Mesarina-Wicki B
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- Administration, Intranasal, Anti-Inflammatory Agents adverse effects, Child, Double-Blind Method, Female, Glucocorticoids, Growth Disorders chemically induced, Humans, Male, Mometasone Furoate, Pregnadienediols adverse effects, Anti-Inflammatory Agents therapeutic use, Growth drug effects, Pregnadienediols therapeutic use, Rhinitis, Allergic, Perennial drug therapy
- Abstract
Objective: Intranasal corticosteroids are used widely for the treatment of allergic rhinitis because they are effective and well tolerated. However, their potential to suppress growth of pediatric subjects with allergic rhinitis continues to be a concern, particularly in light of reports of growth suppression after treatment with intranasal beclomethasone dipropionate or intranasal budesonide (see the article by Skoner et al in this month's issue). A 1-year study of prepubertal patients between 3 and 9 years of age with perennial allergic rhinitis was conducted to assess the effects on growth of mometasone furoate aqueous nasal spray (MFNS), a new once-daily (QD) intranasal corticosteroid with negligible bioavailability., Methods: This was a randomized, placebo-controlled, double-blind, multicenter study. Ninety-eight subjects were randomized to treatment with either MFNS 100 microg QD or placebo for 1 year. Each subject's height was required to be between the 5th and 95th percentile at baseline, and skeletal age at screening was required to be within 2 years of chronological age, as determined by left wrist x-rays. Washout periods for medications that affect either childhood growth or allergic rhinitis symptoms were established based on estimated period of effect, and these medications were prohibited during the study. However, short courses of either oral prednisone lasting no longer than 7 days or low-potency topical dermatologic corticosteroids lasting no longer than 10 days were permitted if necessary. Height was measured with a calibrated stadiometer at baseline and at 4, 8, 12, 26, 39, and 52 weeks, and the primary safety variable was the change in standing height. The rate of growth was also calculated for each subject as the slope (linear regression) of the change in height from baseline using data from all visits of subjects who had at least 2 visits. Hypothalamic-pituitary-adrenocortical- (HPA)-axis function was assessed via cosyntropin stimulation testing at baseline and at 26 and 52 weeks. All analyses were based on all randomized subjects (intent-to-treat principle). The change from baseline in standing height was analyzed by a 2-way analysis of variance that extracted sources of variation attributable to treatment, center, and treatment-by-center interaction., Results: Demographic characteristics were similar at baseline. Eighty-two subjects completed the study (42 in the MFNS group and 40 in the placebo group), and 93% of subjects achieved at least 80% compliance with therapy. After 1 year of treatment, no suppression of growth was seen in subjects treated with MFNS, and mean standing heights were similar for both treatment groups at all time points. For the primary safety variable (change in height from baseline), both treatment groups were similar at all time points except for weeks 8 and 52. Subjects treated with MFNS had a slightly greater mean increase in height than subjects treated with placebo at these time points: the change in height was 6.95 cm versus 6.35 cm at the 1-year time point. However, the rate of growth (.018 cm/day) averaged for all time points over the course of the study was similar for both treatment groups. Additional analyses found that MFNS did not retard growth in any sex or age subgroup of subjects. The use of exogenous corticosteroids other than the study drug was also similar among the 2 treatment groups. Results from cosyntropin stimulation testing confirmed the absence of systemic effects of MFNS. The change from baseline in the difference between prestimulation and poststimulation levels was similar for both treatment groups after 1 year of treatment, with no evidence of HPA-axis suppression in MFNS-treated subjects at any time point. Incidences of treatment-related adverse events were similar for both treatment groups, with 16% of MFNS-treated subjects reporting adverse events, compared with 22% of placebo-treated subjects., Conclusions: (ABSTRACT TRUNCATED)
- Published
- 2000
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26. Prevention of exercise-induced bronchospasm in pediatric asthma patients: A comparison of two salmeterol powder delivery devices.
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Bronsky EA, Pearlman DS, Pobiner BF, Scott C, Wang Y, and Stahl E
- Subjects
- Administration, Inhalation, Adrenergic beta-Agonists therapeutic use, Albuterol administration & dosage, Albuterol therapeutic use, Asthma, Exercise-Induced physiopathology, Child, Child, Preschool, Cross-Over Studies, Double-Blind Method, Exercise Test, Female, Humans, Male, Powders, Salmeterol Xinafoate, Time Factors, Adrenergic beta-Agonists administration & dosage, Albuterol analogs & derivatives, Asthma, Exercise-Induced drug therapy, Bronchial Spasm prevention & control, Nebulizers and Vaporizers
- Abstract
Background: A powder formulation of salmeterol has been shown to prevent exercise-induced bronchospasm (EIB) in asthmatic children and adults; however, the delivery device (Diskhaler; Glaxo Wellcome Inc, Research Triangle Park, NC) must be reloaded after 4 doses. A new multidose powder inhaler (Diskus) provides 60 doses of salmeterol in a blister pack presentation with a dose counter., Objective: To evaluate the safety and efficacy of 50-microg salmeterol powder via two different delivery systems (Diskhaler and Diskus) in preventing EIB in asthmatic children., Study Design: A randomized, double-blind, double-dummy, single-dose, placebo-controlled, three-way crossover study was conducted in 24 children 4 to 11 years of age demonstrating EIB and mild to moderate asthma. Serial forced expiratory volume in 1 second (FEV(1)) was measured before and after treadmill exercise challenges conducted at 1, 6, and 12 hours after study drug administration. Adverse events were also assessed., Results: During all exercise challenges, EIB-mediated reductions in FEV(1) were minimized or prevented in patients receiving single doses of salmeterol powder compared with placebo. Single doses of salmeterol powder delivered via either system were equally effective in preventing EIB. There were no drug-related adverse events, cardiovascular, or other clinically relevant safety concerns., Conclusions: Single doses of salmeterol powder delivered by either delivery system are safe and effective in preventing EIB for >/=12 hours in asthmatic children.
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- 1999
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27. A dose-ranging study of mometasone furoate aqueous nasal spray in children with seasonal allergic rhinitis.
- Author
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Meltzer EO, Berger WE, Berkowitz RB, Bronsky EA, Dvorin DJ, Finn AF, Galant SP, Grossman J, Hampel FC, Ratner PH, Ruff ME, Schenkel EJ, Segal AT, Segall N, Stewart GE 2nd, Tripathy I, Skoner DP, Anolik R, Dockhorn RJ, van Bavel J, Mesarina-Wicki B, and Nolop K
- Subjects
- Administration, Intranasal, Anti-Inflammatory Agents pharmacokinetics, Child, Child, Preschool, Dose-Response Relationship, Drug, Double-Blind Method, Drug Tolerance, Female, Glucocorticoids, Humans, Male, Mometasone Furoate, Placebos, Pregnadienediols pharmacokinetics, Therapeutic Equivalency, Anti-Inflammatory Agents administration & dosage, Pregnadienediols administration & dosage, Rhinitis, Allergic, Seasonal drug therapy
- Abstract
Background: The efficacy and safety of mometasone furoate aqueous nasal spray (MFNS; Nasonex) 200 microg once daily for the treatment and prophylaxis of seasonal allergic rhinitis (SAR) and treatment of perennial rhinitis have been demonstrated in adults. However, the dose response of MFNS in pediatric patients has not yet been characterized., Objective: This study was conducted to determine the dose-response relationship of 3 different doses of MFNS in a pediatric population., Methods: This was a multicenter, double-blind, active- and placebo-controlled study of 679 children 6 to 11 years of age with histories of SAR and documented positive skin test responses. Patients were randomized to one of the following treatment groups for 4 weeks: MFNS 25 microgram once daily, MFNS 100 microgram once daily, MFNS 200 microgram once daily, beclomethasone dipropionate 84 microgram twice daily (168 microgram/day), or placebo. Physician evaluations were performed at days 4, 8, 15, and 29, and patient evaluations were analyzed for days 1 to 15 and 16 to 29., Results: The mean reduction from baseline in physician-evaluated total nasal symptom scores at day 8 (the primary efficacy variable) was significantly greater in the MFNS and beclomethasone dipropionate groups than in the placebo group (P =.02). No significant differences were observed among the 3 MFNS groups. However, as treatment continued, symptoms in patients treated with MFNS 100 or 200 microgram once daily continued to improve, whereas those treated with MFNS 25 microgram once daily demonstrated little further improvement. By day 29, MFNS 100 and 200 microgram once daily both were significantly more effective than MFNS 25 microgram once daily in relieving symptoms of SAR, but MFNS 200 microgram provided no additional benefit over MFNS 100 microgram. All doses of MFNS were well tolerated, and cosyntropin stimulation tests performed before and after treatment found no evidence of hypothalamic-pituitary-adrenal axis suppression., Conclusion: These results indicate that the most appropriate therapeutic dosage of MFNS in the treatment of SAR in children 6 to 11 years of age is 100 microgram once daily. In addition, MFNS at doses up to 200 microgram once daily for 4 weeks was well tolerated and had no detectable effects on hypothalamic-pituitary-adrenal axis function.
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- 1999
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28. Ipratropium bromide nasal spray 0.03% and beclomethasone nasal spray alone and in combination for the treatment of rhinorrhea in perennial rhinitis.
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Dockhorn R, Aaronson D, Bronsky E, Chervinsky P, Cohen R, Ehtessabian R, Finn A, Grossman J, Howland W, Kaiser H, Pearlman D, Sublett J, Ratner P, Settipane G, Sim T, Storms W, Webb R, Drda K, and Wood C
- Subjects
- Administration, Inhalation, Adolescent, Adult, Aged, Anti-Asthmatic Agents administration & dosage, Anti-Asthmatic Agents adverse effects, Anti-Asthmatic Agents therapeutic use, Beclomethasone administration & dosage, Beclomethasone adverse effects, Bronchodilator Agents administration & dosage, Bronchodilator Agents adverse effects, Bronchodilator Agents therapeutic use, Child, Double-Blind Method, Drug Therapy, Combination, Female, Humans, Ipratropium administration & dosage, Ipratropium adverse effects, Male, Middle Aged, Quality of Life, Beclomethasone therapeutic use, Ipratropium therapeutic use, Rhinitis drug therapy, Rhinitis, Allergic, Perennial drug therapy
- Abstract
Background: Perennial rhinitis is a common condition that affects up to 10% to 20% of the population. Multiple agents are frequently administered since no single agent provides complete relief. Studies assessing the benefit/risk of combined therapy are important especially for newly approved agents such as ipratropium bromide nasal spray 0.03%, a topical anticholinergic agent, approved specifically for the treatment of rhinorrhea in allergic and non-allergic perennial rhinitis., Objective: To compare the efficacy and safety of the combined use of ipratropium bromide nasal spray 0.03% (42 microg per nostril tid) and beclomethasone dipropionate nasal spray (84 microg per nostril bid) against that of either active agent alone for the treatment of rhinorrhea., Design: Multicenter, 6-week, double-blind, randomized active- and placebo-controlled, parallel trial., Setting: Allergist and general practitioner clinical practices., Patients: Five hundred thirty-three patients with perennial rhinitis (279 allergic and 274 non-allergic), 8 to 75 years of age, who had at least a mild degree of severity of rhinorrhea for a minimum of 2 hours per day during the 1 week screening period as well as congestion or sneezing also of at least mild severity., Intervention: Either (1) ipratropium bromide nasal spray 0.03% (42 microg per nostril tid) plus beclomethasone dipropionate nasal spray (84 microg per nostril bid), (2) ipratropium bromide nasal spray 0.03% (42 microg per nostril tid) alone, (3) beclomethasone dipropionate nasal spray (84 microg per nostril bid) alone, or (4) vehicle [matching placebo nasal spray for the ipratropium bromide (2 sprays per nostril tid)] or beclomethasone dipropionate (2 sprays per nostril bid)., Main Outcome Measure: Severity and duration of rhinorrhea, and patient and physician global assessment of control of rhinorrhea., Results: Ipratropium bromide nasal spray plus beclomethasone nasal spray was more effective than either active agent alone or vehicle in reducing the average severity and duration of rhinorrhea during 4 weeks of treatment. The advantage of ipratropium bromide plus beclomethasone nasal spray was evident by the first day of combined treatment and continued throughout the 2-week treatment period. Ipratropium bromide nasal spray had a faster onset of action during the first week of treatment and reduced the duration of rhinorrhea more than beclomethasone. Beclomethasone nasal spray was more effective in reducing the severity of congestion and sneezing than ipratropium. In patients who had not responded well to a nasal steroid prior to participation in the study based on a questionnaire administered at screening, ipratropium bromide was as effective in the steroid non-responders as steroid responders, whereas beclomethasone was more effective in steroid responders. Combined active therapy was well tolerated with no increase in adverse events over that seen previously with ipratropium bromide or beclomethasone nasal spray alone., Conclusions: The combined use of ipratropium bromide nasal spray with beclomethasone dipropionate nasal spray is more effective than either active agent for the treatment of rhinorrhea, and does not result in a potentiation of adverse drug reactions. Ipratropium bromide nasal spray 0.03% alone should be considered in patients for whom rhinorrhea is the primary symptom, and its use in combination with a nasal steroid should be considered in patients where rhinorrhea is one of the predominant symptoms, or in patients with rhinorrhea not fully responsive to other therapy.
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- 1999
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29. The leukotriene D4-receptor antagonist zafirlukast attenuates exercise-induced bronchoconstriction in children.
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Pearlman DS, Ostrom NK, Bronsky EA, Bonuccelli CM, and Hanby LA
- Subjects
- Administration, Oral, Adolescent, Analysis of Variance, Anti-Asthmatic Agents adverse effects, Asthma, Exercise-Induced physiopathology, Child, Dose-Response Relationship, Drug, Double-Blind Method, Exercise Test statistics & numerical data, Female, Humans, Indoles, Leukotriene Antagonists adverse effects, Male, Phenylcarbamates, Spirometry statistics & numerical data, Sulfonamides, Time Factors, Tosyl Compounds adverse effects, Anti-Asthmatic Agents administration & dosage, Asthma, Exercise-Induced drug therapy, Bronchoconstriction drug effects, Leukotriene Antagonists administration & dosage, Tosyl Compounds administration & dosage
- Abstract
Objective: To determine the effects of zafirlukast on exercise-induced bronchoconstriction in children., Study Design: Exercise challenges were done 4 hours after single oral doses of zafirlukast or placebo were administered in asthmatic children (6 to 14 years) treated with beta 2-agonists alone. Subjects randomized to treatment had a >/=20% decrease in forced expiratory volume in 1 second (FEV1 ) after a screening challenge. In a randomized, double-blind, 3-way, crossover design, group 1 (n = 20) received placebo and 5 and 20 mg zafirlukast, and group 2 (n = 19) received placebo and 10 and 40 mg zafirlukast. Maximal percentage fall in FEV1, area under the curve, and time to recovery of FEV1 to within 5% of baseline after the challenge were compared with analysis of variance., Results: Mean values for maximal fall in FEV1 ranged from -8.7% +/- 1.7% to -11.1% +/- 1.9% after zafirlukast compared with -17.1% +/- 1.8% and -16.3% +/- 1.9% after placebo. Differences from placebo for fall in FEV1 and area under the curve were significant (P =.05) after 5, 20, and 40 mg zafirlukast and approached significance (P =.08) after 10 mg zafirlukast. After all zafirlukast doses, recovery times (means of 5 to 7 minutes) decreased significantly (P =.05) and by approximately half compared with placebo (11 and 14 minutes). Safety assessments did not differ among treatments., Conclusion: Four hours after dosing, zafirlukast attenuated exercise-induced bronchoconstriction in children.
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- 1999
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30. Switching patients with asthma from chlorofluorocarbon (CFC) albuterol to hydrofluoroalkane-134a (HFA) albuterol.
- Author
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Bronsky E, Ekholm BP, Klinger NM, and Colice GL
- Subjects
- Adult, Albuterol adverse effects, Albuterol therapeutic use, Asthma physiopathology, Female, Forced Expiratory Volume physiology, Humans, Male, Middle Aged, Nebulizers and Vaporizers, Aerosol Propellants adverse effects, Albuterol administration & dosage, Asthma drug therapy, Chlorofluorocarbons adverse effects, Chlorofluorocarbons, Methane adverse effects, Hydrocarbons, Fluorinated adverse effects
- Abstract
Chlorofluorocarbon (CFC) propellants deplete stratospheric ozone. Production and use of CFCs, except for certain critical exemptions, has been prohibited by the Montreal Protocol. Use of CFCs as propellants in metered-dose inhalers (MDIs) is still allowed, but the U.S. Food and Drug Administration is planning the transition to alternative propellants for use in MDIs. Hydrofluoroalkane-134a (HFA), a non-ozone-depleting propellant, has been used to reformulate albuterol (HFA albuterol). This study evaluates whether comparable safety and efficacy continues for 12 weeks after patients with asthma are switched from CFC albuterol to HFA albuterol. Patients with asthma stabilized on CFC albuterol during a 12-week safety and efficacy trial were randomized to either continue receiving CFC albuterol or to be switched to receive HFA albuterol in a yearlong safety and efficacy trial. Safety and efficacy were compared over the first 12 weeks of the yearlong trial between patients who had remained on CFC albuterol and those who had been switched to HFA albuterol. Bronchodilator efficacy was evaluated by serial spirometry for 6 hr after the patients self-administered the study drug in the clinic. Safety was assessed by measuring changes in pulse rate, blood pressure, and electrocardiogram (ECG) intervals after dosing with study drug, monitoring adverse events, and performing prestudy and poststudy laboratory testing and physical examinations. No significant differences in bronchodilator efficacy between the patients continuing to receive CFC albuterol and those switched to HFA albuterol were found in the 12 weeks after the switch. No differences between the two products were found for changes in pulse rate, blood pressure, and ECG intervals. Adverse event profiles were similar for the two products, except the patients remaining on CFC albuterol reported increased asthma symptoms and rhinitis significantly more often than the patients switched to HFA albuterol. No clinically meaningful changes in laboratory tests or physical examinations were found in either treatment group. Patients with asthma switched from CFC albuterol to HFA albuterol receive comparable bronchodilation with a similar safety profile as those continuing to receive CFC albuterol.
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- 1999
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31. Tri-Nasal triamcinolone acetonide nasal spray 200 and 400 micrograms qd versus placebo and Nasacort triamcinolone acetonide nasal aerosol 440 micrograms qd in patients suffering from seasonal allergic rhinitis during the grass season.
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Rosenthal R, Berger W, Bronsky E, Dockhorn R, Korenblat P, Lampl K, Lumry W, Pollard S, Raphael G, Rohr C, Shapiro G, Valentine M, Wanderer A, Fleming L, LaVallee N, Stepanians M, Karafilidis J, Shilstone J, and Ellis E
- Subjects
- Administration, Intranasal, Adolescent, Adult, Aerosols, Aged, Double-Blind Method, Drug Administration Schedule, Female, Glucocorticoids adverse effects, Humans, Male, Middle Aged, Rhinitis, Allergic, Seasonal physiopathology, Triamcinolone Acetonide adverse effects, Glucocorticoids administration & dosage, Rhinitis, Allergic, Seasonal drug therapy, Triamcinolone Acetonide administration & dosage
- Abstract
Tri-Nasal Nasal Spray is an investigational solution of triamcinolone acetonide (TAA) currently being evaluated as a treatment for allergic rhinitis. The safety and efficacy of 200 and 400 micrograms once daily doses of Tri-Nasal Nasal Spray, an active control (440 micrograms once daily of Nasacort Nasal aerosol), and Tri-Nasal Nasal Spray placebo were compared over a 2-week treatment period in a double-blind (the Nasacort treatment was not blinded), parallel design trial. A total of 377 adult patients in 13 centers were enrolled during the grass pollen season. The primary efficacy variable was the weekly average of the SSI (Symptom Severity Index), the sum of daily nasal congestion, rhinorrhea, and sneezing severity scores from the patient diary. A total of 355 patients completed the study. All active treatments were significantly more effective than placebo in relieving nasal symptoms at each treatment week. The 400 micrograms Tri-Nasal Nasal Spray and Nasacort treatments had a rapid onset of action, demonstrating significant improvement in the SSI versus placebo by the second day of treatment. Results for the individual nasal symptoms and other secondary efficacy measures paralleled those of the primary efficacy variables. Tri-Nasal Nasal Spray and Nasacort were comparable in safety, and in treating the nonocular symptoms of seasonal allergic rhinitis.
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- 1998
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32. Montelukast, a leukotriene-receptor antagonist, for the treatment of mild asthma and exercise-induced bronchoconstriction.
- Author
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Leff JA, Busse WW, Pearlman D, Bronsky EA, Kemp J, Hendeles L, Dockhorn R, Kundu S, Zhang J, Seidenberg BC, and Reiss TF
- Subjects
- Acetates pharmacology, Adolescent, Adrenergic beta-Agonists therapeutic use, Adult, Anti-Asthmatic Agents pharmacology, Asthma, Exercise-Induced physiopathology, Bronchial Provocation Tests, Bronchoconstriction drug effects, Cyclopropanes, Double-Blind Method, Exercise, Female, Forced Expiratory Volume drug effects, Humans, Male, Methacholine Chloride, Middle Aged, Quinolines pharmacology, Sulfides, Acetates therapeutic use, Anti-Asthmatic Agents therapeutic use, Asthma, Exercise-Induced drug therapy, Leukotriene Antagonists, Quinolines therapeutic use
- Abstract
Background: Patients with mild asthma frequently have only exercise-induced bronchoconstriction, a symptom of inadequate control of asthma. We evaluated the ability of montelukast, a leukotriene-receptor antagonist, to protect such patients against exercise-induced bronchoconstriction., Methods: We randomly assigned 110 patients (age, 15 to 45 years) with mild asthma and a decrease in the forced expiratory volume in one second (FEV1) of at least 20 percent after exercise on two occasions during a placebo run-in period to receive 10 mg of montelukast (54 patients) or placebo (56 patients) once daily at bedtime for 12 weeks in a double-blind study. Treatment was followed by a two-week, single-blind washout period during which all patients received placebo. Exercise challenges were performed at base line; 20 to 24 hours after dosing at weeks 4, 8, and 12; and at the end of the washout period. The primary end point was the area under the curve for FEV1 (expressed as the percent change from base-line values) in the first 60 minutes after exercise. This measure summarized the extent and duration of bronchoconstriction after exercise., Results: At 12 weeks, montelukast therapy offered significantly greater protection against exercise-induced bronchoconstriction than placebo therapy (expressed as the percentage of inhibition of the end points), as evidenced by the improvement in the area under the FEV1 curve (degree of inhibition, 47.4 percent; P=0.002). Montelukast therapy was also associated with a significant improvement in the maximal decrease in FEV1 after exercise (P=0.003) and the time from the maximal decrease in FEV1 to the return of lung function to within 5 percent of pre-exercise values (P=0.04). The differences between groups in the various measures of lung function were similar at 4, 8, and 12 weeks; there was no evidence of rebound worsening of lung function in the montelukast group after the washout period. After 12 weeks of treatment, patients in the montelukast group were more likely to rate their asthma control as better and less likely to require rescue therapy with a beta-agonist during or after exercise challenge. The rates of adverse events were similar in the two groups., Conclusions: As compared with placebo, once-daily treatment with montelukast provided significant protection against exercise-induced asthma over a 12-week period. Tolerance to the medication and rebound worsening of lung function after discontinuation of treatment were not seen.
- Published
- 1998
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33. Efficacy of salmeterol xinafoate powder in children with chronic persistent asthma.
- Author
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Weinstein SF, Pearlman DS, Bronsky EA, Byrne A, Arledge T, Liddle R, and Stahl E
- Subjects
- Albuterol adverse effects, Albuterol therapeutic use, Asthma physiopathology, Child, Child, Preschool, Chronic Disease, Double-Blind Method, Female, Forced Expiratory Volume drug effects, Humans, Male, Powders, Salmeterol Xinafoate, Albuterol analogs & derivatives, Asthma drug therapy, Bronchodilator Agents therapeutic use
- Abstract
Background: The efficacy and safety of salmeterol powder have not previously been evaluated in children with asthma in the United States., Objective: The efficacy and safety of salmeterol powder versus placebo were compared in children between the ages of 4 and 11 years with chronic persistent asthma., Methods: A randomized, double-blind, placebo-controlled, parallel group trial was performed at 11 clinical centers. Two hundred seven patients were randomly assigned to receive 50 microg salmeterol powder or placebo (and albuterol as needed) twice daily via a breath-actuated device for 12 weeks. Twelve-hour serial pulmonary function assessments were conducted on day 1 and at week 12. Daily recordings of morning and evening peak expiratory flow (PEF), supplemental albuterol use, asthma symptoms, and nocturnal awakenings were assessed., Results: On day 1 and at week 12, weighted mean percent of predicted PEF (P < .001, day 1 and P=.008, week 12) and weighted mean forced expiratory volume in one second (P < .001, day 1 and week 12) were significantly higher at all timepoints evaluated over the 12-hour postdosing period in patients treated with salmeterol powder compared with placebo. Overall reductions in supplemental albuterol use and mean asthma symptom scores were also significantly greater in children administered salmeterol compared with placebo (P=.004 and P=.006, respectively). The frequency of adverse events was similar in the two treatment groups., Conclusion: Salmeterol powder (50 microg twice daily) is effective and safe in producing bronchodilation and relieving symptoms in children with chronic persistent asthma during 12 weeks of treatment.
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- 1998
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34. Comparative efficacy and safety of once-daily versus twice-daily loratadine-pseudoephedrine combinations versus placebo in seasonal allergic rhinitis.
- Author
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Kaiser HB, Banov CH, Berkowitz RR, Bernstein DI, Bronsky EA, Georgitis JW, Mendelson LM, Rooklin AR, Sholler LJ, Stricker WW, Harrison JE, Danzig MR, and Lorber RR
- Subjects
- Adolescent, Adult, Aged, Analysis of Variance, Anti-Allergic Agents adverse effects, Child, Delayed-Action Preparations, Double-Blind Method, Drug Administration Schedule, Drug Combinations, Ephedrine adverse effects, Female, Humans, Loratadine adverse effects, Male, Middle Aged, Tablets, Treatment Outcome, United States, Vasoconstrictor Agents adverse effects, Anti-Allergic Agents administration & dosage, Ephedrine administration & dosage, Loratadine administration & dosage, Rhinitis, Allergic, Seasonal drug therapy, Vasoconstrictor Agents administration & dosage
- Abstract
The objective of this study was to compare the efficacy and safety of Claritin-D 24 Hour (once daily) with that of Claritin-D 12 Hour (twice daily) and placebo in the treatment of patients with seasonal allergic rhinitis (SAR). In this double-blind, placebo-controlled, multicenter study, 469 patients with moderate-to-severe SAR symptoms were treated for 2 weeks with one of the following: Claritin-D 24 Hour (a combination tablet formulation of loratadine 10 mg in the coating and pseudoephedrine sulfate 240 mg in an extended-release core), Claritin-D 12 Hour (a combination tablet formulation of loratadine 5 mg in the tablet coating and 120 mg pseudoephedrine sulfate, 60 mg in the coating and 60 mg in the core), or placebo. Claritin-D 24 Hour and Claritin-D 12 Hour were consistently superior to placebo (P < 0.01) in reducing total, nasal, and nonnasal symptom scores. Patients in the Claritin-D 24 Hour and Claritin-D 12 Hour groups also had significantly greater (P = 0.05) relief of rhinorrhea and nasal stuffiness as compared with placebo. Insomnia was reported significantly more often (P < 0.01) in Claritin-D 12 Hour (15%) patients compared with Claritin-D 24 Hour (4%) and placebo (2%) patients. Dry mouth was reported significantly more often (P < 0.05) in Claritin-D 24 Hour (13%) and Claritin-D 12 Hour (13%) groups compared with placebo (4%). Claritin-D 24 Hour has efficacy comparable to Claritin-D 12 Hour in relieving allergic rhinitis symptoms while producing significantly less insomnia.
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- 1998
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35. Dose-related efficacy of budesonide administered via a dry powder inhaler in the treatment of children with moderate to severe persistent asthma.
- Author
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Shapiro G, Bronsky EA, LaForce CF, Mendelson L, Pearlman D, Schwartz RH, and Szefler SJ
- Subjects
- Administration, Inhalation, Administration, Topical, Adolescent, Anti-Inflammatory Agents therapeutic use, Bronchodilator Agents therapeutic use, Budesonide therapeutic use, Child, Dose-Response Relationship, Drug, Double-Blind Method, Drug Administration Schedule, Female, Forced Expiratory Volume drug effects, Humans, Hydrocortisone blood, Male, Nebulizers and Vaporizers, Peak Expiratory Flow Rate drug effects, Powders, Anti-Inflammatory Agents administration & dosage, Asthma drug therapy, Bronchodilator Agents administration & dosage, Budesonide administration & dosage
- Abstract
Objective: To determine the efficacy and safety of budesonide delivered by an inhalation-driven dry powder inhaler (Turbuhaler) in children with moderate to severe persistent asthma., Study Design: In our randomized, double-blind, placebo-controlled, parallel-group, multicenter study, a total of 404 children with asthma, who were aged 6 to 18 years and who had been receiving inhaled glucocorticosteroid therapy, were randomly assigned to receive either 100, 200, or 400 micrograms of budesonide or placebo twice daily for 12 weeks. At baseline, mean forced expiratory volume in 1 second (FEV1) was 74.6% (range, 30.7% to 123.3%) of the predicted normal value., Results: Patients in each of the three budesonide treatment groups showed significant dose-related improvements in lung function (morning peak expiratory flow and FEV1), in asthma symptoms, and with a significant decrease in inhaled beta 2-agonist use in comparison with placebo. Improvements were evident within 2 weeks and were maintained throughout the 12 weeks. Budesonide treatment had no significant effect on hypothalamic-pituitary-adrenal axis function, and the incidence of reported adverse events was similar in all treatment groups., Conclusion: Budesonide administered via a dry powder inhaler provided dose-related improvements in lung function and clinical status and was well tolerated by children (6 to 18 years of age) with moderate to severe persistent asthma.
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- 1998
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36. Effectiveness and safety of fexofenadine, a new nonsedating H1-receptor antagonist, in the treatment of fall allergies.
- Author
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Bronsky EA, Falliers CJ, Kaiser HB, Ahlbrandt R, and Mason JM
- Subjects
- Administration, Oral, Adolescent, Adult, Double-Blind Method, Female, Histamine Antagonists adverse effects, Humans, Male, Middle Aged, Single-Blind Method, Terfenadine adverse effects, Terfenadine therapeutic use, Treatment Outcome, Histamine Antagonists therapeutic use, Rhinitis, Allergic, Seasonal drug therapy, Terfenadine analogs & derivatives
- Abstract
Fexofenadine HCl is a new, nonsedating H1-receptor antagonist approved for treatment of seasonal allergic rhinitis (SAR). In a double-blind, randomized, placebo-controlled, multicenter trial, 588 patients with fall SAR rated the severity of their symptoms using a scoring system at a screening visit and during a 3-day placebo lead-in period. Patients who did not respond to placebo and met symptom severity criteria were randomized to receive placebo or fexofenadine HCl at 40, 60, or 120 mg bid at 7:00 a.m. and 7:00 p.m. for 14 days. Patients continued to rate the severity of their symptoms immediately before receiving each dose (at trough). A total of 545 patients were included in an intent-to-treat analysis. The change from baseline in the primary efficacy variable (average daily 7:00 p.m. reflective symptom scores) was significantly greater in patients receiving all dosages of fexofenadine HCl than placebo (p < 0.01). All active dosages produced significant decreases (p < 0.05) in secondary end points: 7:00 a.m. reflective symptom scoring; 7:00 a.m. and 7:00 p.m. scoring 1-hour before dose; and bedtime scoring 1-3 hours after the 7:00 p.m. dose. All dosages of fexofenadine HCl were well tolerated, and no effect on QTc was observed. In conclusion, fexofenadine HCl is safe and effective in the treatment of fall SAR, with 60 mg bid being the optimal therapeutic dosage.
- Published
- 1998
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37. Comparative clinical study of inhaled beclomethasone dipropionate and triamcinolone acetonide in persistent asthma.
- Author
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Bronsky E, Korenblat P, Harris AG, and Chen R
- Subjects
- Administration, Inhalation, Adolescent, Adult, Aged, Double-Blind Method, Female, Forced Expiratory Volume, Humans, Male, Middle Aged, Anti-Asthmatic Agents therapeutic use, Asthma drug therapy, Beclomethasone therapeutic use, Glucocorticoids therapeutic use, Triamcinolone Acetonide therapeutic use
- Abstract
Unlabelled: At this time, no placebo-controlled studies in the clinical literature compare the efficacy and safety of the most widely prescribed oral inhaled corticosteroids when dosed at their recommended daily doses. This study compared the efficacy and safety of beclomethasone dipropionate (BDP) 336 microg/day administered by metered dose inhaler (MDI) alone, and triamcinolone acetonide (TA) 800 microg/day by MDI with a built-in tube extender in adults with persistent asthma., Methods: This 56-day, randomized, double-blind, double-dummy, placebo-controlled, multicenter trial was conducted in 328 adults with mild to moderately severe asthma (FEV1 50% to 90% of predicted while maintained on inhaled corticosteroids). Patients were seen at a baseline visit and on study days 28 and 56. Efficacy variables included pulmonary function tests, physician and patient assessments of asthma condition, and use of rescue medication., Results: Statistically significant improvements from baseline in most efficacy measures were demonstrated for both active treatments versus placebo, and with the following exception were the same between active treatments: mean increase in FEV1 in the beclomethasone dipropionate group was statistically significantly greater than in the triamcinolone acetonide group on day 28. Throughout the study, BDP was statistically superior to TA with respect to mean change from baseline in total asthma symptom scores and for 3 of 8 weeks in reducing the mean average weekly use of rescue albuterol (the two active treatments were comparable for this variable at all other time points). Beclomethasone dipropionate and TA were comparable in safety., Conclusion: In adult patients with mild to moderately severe persistent asthma, treatment with BDP consistently conferred greater improvement from baseline in mean FEV1 than TA. This difference achieved statistical significance after 28 days of therapy but was not maintained to endpoint. Decreases in overall asthma symptom scores and in the use of rescue albuterol were statistically significantly greater for the BDP group compared with the TA group. Based on these findings, we conclude that BDP is at least as effective as TA in the treatment of persistent asthma in adults, and judged by some measures, may be superior.
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- 1998
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38. Growth in asthmatic children treated with fluticasone propionate. Fluticasone Propionate Asthma Study Group.
- Author
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Allen DB, Bronsky EA, LaForce CF, Nathan RA, Tinkelman DG, Vandewalker ML, and Konig P
- Subjects
- Administration, Inhalation, Androstadienes adverse effects, Anti-Asthmatic Agents adverse effects, Anti-Asthmatic Agents pharmacology, Asthma physiopathology, Child, Child, Preschool, Dose-Response Relationship, Drug, Double-Blind Method, Female, Fluticasone, Glucocorticoids adverse effects, Glucocorticoids pharmacology, Humans, Male, Androstadienes administration & dosage, Anti-Asthmatic Agents therapeutic use, Asthma drug therapy, Glucocorticoids therapeutic use, Growth drug effects
- Abstract
Objective: To determine whether inhaled fluticasone propionate has long-term effects on growth in children with persistent asthma., Study Design: In a double-blind, randomized, parallel-group, multicenter study, 325 prepubescent children with persistent asthma and normal growth rates were treated with placebo or inhaled fluticasone propionate powder 50 microg or 100 microg administered twice daily by a breath-actuated device for 1 year. Growth was evaluated monthly, whereas other safety variables and pulmonary function were evaluated periodically., Results: The prepubescent patients showed no statistically significant differences in mean height, mean growth velocity, or mean skeletal age between any of the treatment groups at any time. Over a period of 1 year, mean height (+/- SE) increased 6.15 +/- 0.17 cm in the placebo group, 5.94 +/- 0.16 cm in the fluticasone propionate 50 microg group, and 5.73 +/- 0.13 cm in the fluticasone propionate 100 microg group (p = 0.308, overall)., Conclusions: Prepubescent children treated with fluticasone propionate 50 microg and 100 microg administered twice daily for 1 year grew at rates similar to placebo-treated control subjects and at rates equal to expected growth velocity for age.
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- 1998
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39. Efficacy and safety of loratadine plus pseudoephedrine in patients with seasonal allergic rhinitis and mild asthma.
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Corren J, Harris AG, Aaronson D, Beaucher W, Berkowitz R, Bronsky E, Chen R, Chervinsky P, Cohen R, Fourre J, Grossman J, Meltzer E, Pedinoff A, Stricker W, and Wanderer A
- Subjects
- Adolescent, Adult, Aged, Albuterol therapeutic use, Asthma physiopathology, Child, Double-Blind Method, Drug Therapy, Combination, Ephedrine adverse effects, Female, Humans, Loratadine adverse effects, Male, Middle Aged, Quality of Life, Respiratory Function Tests, Rhinitis, Allergic, Seasonal physiopathology, Treatment Outcome, Asthma drug therapy, Ephedrine therapeutic use, Loratadine therapeutic use, Rhinitis, Allergic, Seasonal drug therapy
- Abstract
Background: Antihistamines have been shown to have a variety of therapeutic effects in asthma. Although nasal obstruction may play an important role in modulating lower airway function, no prior trial has used a decongestant in combination with an antihistamine in patients with allergic rhinitis and concomitant asthma., Objective: We sought to determine the efficacy and safety of loratadine (5 mg) plus pseudoephedrine (120 mg) (L/P) twice daily in patients with seasonal allergic rhinitis and mild asthma., Methods: We conducted a randomized, double-blind, placebo-controlled trial of L/P in 193 subjects during the fall allergy season. Nasal and chest symptoms, albuterol use, and peak expiratory flow rates were recorded daily for 6 weeks. Spirometry was measured at baseline and after 1, 2, 4, and 6 weeks of therapy, and health-related quality of life was rated at the beginning and end of the study., Results: Total rhinitis and asthma symptom severity scores were significantly reduced in patients receiving active therapy compared with those receiving placebo throughout the 6-week study. Peak expiratory flow rates improved significantly in patients treated with L/P during weeks 2 through 6 (peak effect [mean +/- SEM]: L/P, 26.23 +/- 4.64 L/min vs placebo, 8.52 +/- 3.53 L/min, p = 0.002) as did FEV1 (peak effect [mean +/- SEM]: L/P, 170 +/- 53 ml vs placebo, 20 +/- 40 ml, p = 0.01) at all clinic visits. In addition, select measures of asthma-specific quality of life improved significantly relative to placebo., Conclusions: L/P significantly improved nasal and asthma symptoms, pulmonary function, and quality of life in patients with seasonal allergic rhinitis and concomitant mild asthma.
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- 1997
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40. Dose-related protection of exercise bronchoconstriction by montelukast, a cysteinyl leukotriene-receptor antagonist, at the end of a once-daily dosing interval.
- Author
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Bronsky EA, Kemp JP, Zhang J, Guerreiro D, and Reiss TF
- Subjects
- Acetates administration & dosage, Adult, Analysis of Variance, Area Under Curve, Cross-Over Studies, Cyclopropanes, Dose-Response Relationship, Drug, Double-Blind Method, Drug Administration Schedule, Humans, Middle Aged, Quinolines administration & dosage, Sulfides, Acetates pharmacology, Bronchoconstriction drug effects, Exercise, Quinolines pharmacology, Receptors, Leukotriene B4 drug effects
- Abstract
The dose-related protective effects of montelukast, a potent and selective cysteinyl leukotriene-receptor antagonist, against exercise-induced bronchoconstriction were investigated in a five-period, randomized, incomplete-block, crossover study with montelukast (0.4, 2, 10, 50 mg) and placebo. The study subjects were 27 nonsmoking, healthy stable patients with asthma (mean forced expiratory volume in 1 second [FEV1], 82.0% predicted) who demonstrated a > or = 20% decrease in FEV1 while beta-agonist was withheld for 6 hours before treadmill exercise. The standard exercise challenge was performed 20 to 24 hours, and again 32 to 36 hours, after the second of two once-daily doses. The effect of oral montelukast on exercise was measured by the area above the postexercise percentage decrease in FEV1 versus time curve from 0 to 60 minutes [AUC(0-60)], the maximal percentage decrease in FEV1 after exercise, and time after maximal decrease to recovery of FEV1 to within 5% of the preexercise baseline. Twenty to 24 hours after administration, montelukast caused dose-related protection, while providing similar protection against exercise-induced bronchoconstriction at the two highest doses. The AUC(0-60) values (mean +/- SD) were 637 +/- 898, 715 +/- 870, 988 +/- 1147, and 927 +/- 968 min. % for 50, 10, 2, and 0.4 mg montelukast, respectively, and 1193 +/- 1097 min. % for placebo (p = 0.003). No important clinical effect was present 36 hours after dosing. Montelukast was generally well tolerated at all dose levels. In conclusion, montelukast caused dose-related protection against exercise-induced bronchoconstriction at the end of a once-daily dosing interval. Protection against exercise-induced bronchoconstriction can be used to determine appropriate dose selection.
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- 1997
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41. Dose ranging study of mometasone furoate (Nasonex) in seasonal allergic rhinitis.
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Bronsky EA, Aaronson DW, Berkowitz RB, Chervinsky P, Graft D, Kaiser HB, Moss B, Nathan RA, Pearlman DS, Ratner PH, Adelglass JM, Southern DL, van Bavel J, Hampel F, Stricker WE, Fourré JA, Cuss FM, and Nolop KB
- Subjects
- Administration, Intranasal, Adolescent, Adult, Aged, Dose-Response Relationship, Drug, Double-Blind Method, Female, Glucocorticoids, Humans, Male, Middle Aged, Mometasone Furoate, Anti-Inflammatory Agents administration & dosage, Pregnadienediols administration & dosage, Rhinitis, Allergic, Seasonal drug therapy
- Abstract
Background: Topical nasal corticosteroids are rapidly gaining acceptance as first-line therapy for seasonal allergic rhinitis, but there is a desire for effective corticosteroids with an improved safety profile over existing products., Objective: A multicenter, double-blind dose ranging study was conducted to compare the activity and tolerance of four doses of mometasone furoate nasal spray (tradename Nasonex) and placebo in adult patients with seasonal allergic rhinitis., Methods: Four hundred eighty patients with seasonal allergic rhinitis were enrolled and randomized to receive mometasone furoate nasal spray 50 micrograms (n = 96), 100 micrograms (n = 95), 200 micrograms (n = 98) or 800 micrograms (n = 95), or placebo vehicle (n = 95) once daily for 28 days., Results: All of the doses of mometasone furoate nasal spray showed activity in reducing the severity of rhinitis. The 200-microgram dose reduced total nasal symptom scores and total symptom scores throughout the study (P < .05 versus placebo vehicle). The 50-microgram dose and the 100-microgram dose showed less consistent activity at early timepoints (days 3 and 7), while the 800 microgram dose did not provide significant additional benefits over the 200-microgram dose. All dose levels were well tolerated, Conclusion: The results of this trial indicate that 200 micrograms once daily is the optimum dose of mometasone furoate nasal spray for the treatment of seasonal allergic rhinitis.
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- 1997
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42. The effectiveness of once-daily dosing of inhaled flunisolide in maintaining asthma control.
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ZuWallack RL, Rosen JP, Cohen L, Rachelefsky GS, Gong H Jr, Goldsobel AB, Kaliner MA, White MV, Bronsky EA, Chervinsky P, Lotner GZ, Corren J, and Bodenheimer S
- Subjects
- Administration, Inhalation, Adolescent, Adult, Albuterol therapeutic use, Bronchial Provocation Tests, Bronchodilator Agents therapeutic use, Child, Double-Blind Method, Female, Fluocinolone Acetonide administration & dosage, Fluocinolone Acetonide therapeutic use, Forced Expiratory Volume, Humans, Hydrocortisone analysis, Hydrocortisone urine, Male, Methacholine Chloride pharmacology, Middle Aged, Peak Expiratory Flow Rate, Anti-Inflammatory Agents administration & dosage, Anti-Inflammatory Agents therapeutic use, Asthma drug therapy, Fluocinolone Acetonide analogs & derivatives
- Abstract
Objective: The purpose of this study was to evaluate the feasibility of switching to once-daily (qd) administration of flunisolide in patients with asthma that was controlled by twice-daily (bid) dosing of this inhaled steroid., Methods: Three hundred sixty-six adults and children with bronchial asthma that was controlled with inhaled steroids were recruited for this prospective, double-blind, parallel-group study. After a 4-week, stable baseline period of flunisolide administration, 2 inhalations (500 microg) twice daily, each patient was randomized into one of four 12-week flunisolide treatment groups: group 1, 2 inhalations (500 microg) bid; group 2, 4 inhalations (1000 microg) qd in the morning; group 3, 4 inhalations (1000 microg) qd in the evening; or group 4, 2 inhalations (500 microg) qd in the morning. Outcome measures included morning and evening asthma symptoms (scale of 0 to 3), daytime and nighttime albuterol use, morning and evening peak expiratory flow rate (PEFR), FEV1, and methacholine PC20. In addition, a subset of patients in each group had 24-hour urinary cortisol levels measured before and after randomization., Results: Outcome measures in the four groups were not significantly different at baseline before randomization. The three groups that received maintenance therapy with flunisolide, 1000 microg daily, did not show significant changes from baseline values and remained comparable in all outcome areas. Asthma control in the group randomized to flunisolide 500 microg qd, however, deteriorated significantly: morning symptoms increased by 0.21 units (48%), evening symptoms increased by 0.15 units (31%), daytime albuterol use increased by 0.42 inhalations per day (37%), nighttime albuterol use increased by 0.48 inhalations per night (91%), morning PEFR decreased by 17.1 L/min (4%), and evening PEFR decreased by 12.6 L/min (3%). There were no significant changes in PC20 or 24-hour urinary cortisol levels in any group., Conclusions: For patients with asthma that was stabilized by 2 inhalations of flunisolide (500 microg) bid, switching to 4 inhalations (1000 microg) qd in either the morning or evening is effective in maintaining asthma control. Reducing the dose to 2 inhalations (500 microg) qd in the morning, however, leads to a deterioration in asthma control.
- Published
- 1997
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43. A one-week dose-ranging study of inhaled salmeterol in children with asthma.
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Weinstein S, Chervinsky P, Pollard SJ, Bronsky EA, Nathan RA, Prenner B, Howland WC 3rd, Stahl E, and Liddle R
- Subjects
- Administration, Inhalation, Albuterol administration & dosage, Albuterol adverse effects, Bronchodilator Agents adverse effects, Child, Child, Preschool, Dose-Response Relationship, Drug, Double-Blind Method, Heart Rate drug effects, Humans, Respiratory Mechanics drug effects, Salmeterol Xinafoate, Treatment Outcome, Albuterol analogs & derivatives, Asthma drug therapy, Bronchodilator Agents administration & dosage
- Abstract
This was a 1-week study evaluating the safety and efficacy of two dosage regimens of salmeterol in children with asthma. A total of 243 children, aged 4-11 years, with mild-to-moderate asthma were enrolled in a randomized, double-blind, placebo-controlled, parallel-group, multicenter study evaluating salmeterol xinafoate 21 micrograms and 42 micrograms administered via metered-dose inhaler (MDI) twice daily for 1 week. Patients were allowed to use albuterol MDI as needed for relief of acute symptoms. Inhaled corticosteroids and/or cromolyn at fixed dosages could be continued during the study, but theophylline and oral beta-agonists were not allowed. Twelve-hour serial spirometry (for patients aged 6-11 years) and serial peak expiratory flow rate (PEFR) (all patients) were performed on days 1 and 8 of treatment; morning and evening PEFR were recorded each day prior to inhalation of the study drug. Safety was assessed by monitoring adverse events, clinical laboratory values, vital signs, electrocardiogram (ECG), and 24-hr ECG (Holter) monitoring. Both the 21-micrograms and 42-micrograms doses of salmeterol produced significantly greater bronchodilation, as measured by 12-hr serial forced expiratory volume in 1 sec (FEV1) (p < or = 0.02) and PEFR (p < or = 0.001), than did placebo on days 1 and 8. A small dose-response was observed, with the 42-micrograms dosage producing consistently higher serial FEV1 and PEFR than did the 21-micrograms dosage, although the differences were not statistically significant. Morning and evening PEFR increased significantly (p < or = 0.008) with both dosages of salmeterol compared with placebo. Twelve patients (5%) experienced potentially drug-related adverse events, with headache (4% in each salmeterol group) being the most common. There were no clinically significant changes in heart rate as measured by Holter monitoring, ECGs, vital signs, or clinical laboratory values following treatment with either dose of salmeterol. Salmeterol 21 micrograms or 42 micrograms twice daily was effective in producing bronchodilation in children aged 4-11 years, and both dosages had good safety profiles. Patients treated with salmeterol 42 micrograms twice daily showed a trend toward greater improvement in asthma control compared with those who received salmeterol 21 micrograms.
- Published
- 1997
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44. Results of the first U.S. double-blind, placebo-controlled, multicenter clinical study in asthma with pranlukast, a novel leukotriene receptor antagonist.
- Author
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Grossman J, Faiferman I, Dubb JW, Tompson DJ, Busse W, Bronsky E, Montanaro A, Southern L, and Tinkelman D
- Subjects
- Adult, Anti-Asthmatic Agents adverse effects, Anti-Asthmatic Agents pharmacokinetics, Chromones adverse effects, Chromones pharmacokinetics, Double-Blind Method, Female, Forced Expiratory Volume drug effects, Humans, Leukotriene Antagonists, Male, United States, Anti-Asthmatic Agents therapeutic use, Asthma drug therapy, Chromones therapeutic use
- Abstract
Pranlukast (SB 205312; ONO-1078), a potent, orally active selective cysteinyl-leukotriene receptor antagonist (LTRA), was developed in Japan for the treatment of asthma. This article reports results of the initial U.S. clinical evaluation of pranlukast. The primary objective of this multicenter study was to evaluate the safety and tolerability of pranlukast administered at doses of 337.5 mg b.i.d. and 450 mg b.i.d. in 65 patients with mild to moderate asthma. Pranlukast, a novel LTRA, is safe and well tolerated at doses of 337.5 mg b.i.d. and 450 mg b.i.d. Pranlukast has demonstrated clinical activity in patients with asthma.
- Published
- 1997
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45. Fluticasone propionate aqueous nasal spray compared with terfenadine tablets in the treatment of seasonal allergic rhinitis.
- Author
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Bronsky EA, Dockhorn RJ, Meltzer EO, Shapiro G, Boltansky H, LaForce C, Ransom J, Weiler JM, Blumenthal M, Weakley S, Wisniewski M, Field E, and Rogenes P
- Subjects
- Administration, Intranasal, Administration, Oral, Adolescent, Adult, Aged, Androstadienes administration & dosage, Androstadienes adverse effects, Anti-Allergic Agents administration & dosage, Anti-Allergic Agents adverse effects, Child, Double-Blind Method, Female, Fluticasone, Humans, Male, Middle Aged, Nebulizers and Vaporizers, Rhinitis, Allergic, Seasonal complications, Tablets, Terfenadine administration & dosage, Androstadienes therapeutic use, Anti-Allergic Agents therapeutic use, Rhinitis, Allergic, Seasonal drug therapy, Terfenadine therapeutic use
- Abstract
Background: Comparative studies with topical corticosteroids and antihistamines for treatment of allergic rhinitis have not always demonstrated clear distinctions between the two on the basis of therapeutic efficacy., Objective: This study was designed to compare the efficacy and tolerability of fluticasone propionate aqueous nasal spray with those of terfenadine in the treatment of seasonal allergic rhinitis., Methods: Three hundred forty-eight patients with allergic rhinitis were given fluticasone propionate aqueous nasal spray (200 micrograms once daily), terfenadine tablets (60 mg twice daily), or placebo for 4 weeks in a multicenter, randomized, double-blind, double-dummy, parallel-group study., Results: Clinician-rated total nasal symptom scores after 1, 2, 3, and 4 weeks of therapy and patient-rated total nasal symptom scores throughout treatment were significantly (p <0.05) lower in the fluticasone propionate group compared with the terfenadine group or the placebo group. Terfenadine was not statistically different from placebo on the basis of clinician-related nasal symptom scores, except for sneezing. Total nasal airflow, measured by rhinomanometry, significantly (p <0.05) improved in the fluticasone propionate group compared with the terfenadine group or the placebo group. More fluticasone propionate-treated patients compared with placebo-treated patients had reduced nasal mucosal eosinophil counts after 4 weeks of therapy (p <0.05). No serious or unusual drug-related adverse events were reported. Morning plasma cortisol concentrations after 4 weeks of therapy did not differ among groups., Conclusion: Fluticasone propionate aqueous nasal spray is more effective than terfenadine tablets for treatment of seasonal allergic rhinitis.
- Published
- 1996
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46. Cetirizine and astemizole therapy for chronic idiopathic urticaria: a double-blind, placebo-controlled, comparative trial.
- Author
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Breneman D, Bronsky EA, Bruce S, Kalivas JT, Klein GL, Roth HL, Tharp MD, Treger C, and Soter N
- Subjects
- Adult, Astemizole adverse effects, Astemizole pharmacokinetics, Cetirizine adverse effects, Cetirizine pharmacokinetics, Double-Blind Method, Drug Administration Schedule, Female, Humans, Male, Time Factors, Astemizole administration & dosage, Cetirizine administration & dosage, Urticaria drug therapy
- Abstract
Background: Cetirizine and astemizole have been shown to be safe and effective in the treatment of patients with chronic idiopathic urticaria. Cetirizine brings about clinical benefit more rapidly., Objective: The purpose of this study was to compare the efficacy of single daily doses of cetirizine and astemizole in relieving the symptoms of chronic idiopathic urticaria, with particular emphasis on the commencement of action., Methods: Patients with chronic idiopathic urticaria were randomly assigned to relieve either 10 mg of cetirizine, 10 mg of astemizole, or placebo for 4 weeks in a multicenter double-blind trial. Patients rated symptom severity each night, and investigators rated symptoms weekly., Results: One hundred eighty-seven patients were enrolled in the trial; 180 were included in the safety analysis and 177 were included in at least one efficacy analysis. Both cetirizine and astemizole were significantly superior to placebo in relieving symptoms of chronic idiopathic urticaria. Both patients' and investigators' ratings indicated that cetirizine acted more rapidly. Both active treatments were well tolerated, and the incidence of somnolence did not differ statistically between cetirizine (14.5%) and astemizole (10.3%)., Conclusion: Both cetirizine and astemizole provide effective relief of the symptoms of chronic idiopathic urticaria with similar side-effect profiles. However, clinical benefit occurs significantly more rapidly with cetirizine.
- Published
- 1995
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47. Comparative efficacy and safety of a once-daily loratadine-pseudoephedrine combination versus its components alone and placebo in the management of seasonal allergic rhinitis.
- Author
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Bronsky E, Boggs P, Findlay S, Gawchik S, Georgitis J, Mansmann H, Sholler L, Wolfe J, Meltzer E, and Morris R
- Subjects
- Adolescent, Adult, Aged, Aged, 80 and over, Child, Double-Blind Method, Drug Therapy, Combination, Ephedrine adverse effects, Ephedrine therapeutic use, Female, Humans, Loratadine adverse effects, Loratadine therapeutic use, Male, Middle Aged, Ephedrine administration & dosage, Loratadine administration & dosage, Rhinitis, Allergic, Seasonal drug therapy
- Abstract
Background: The treatment of symptoms of seasonal allergic rhinitis often requires the use of a decongestant to improve nasal congestion, along with an antihistamine to adequately control other nasal, as well as nonnasal symptoms., Methods: In this double-blind, placebo-controlled, multicenter study, 874 patients with moderate to severe symptoms of seasonal allergic rhinitis were treated with one of the following: SCH 434 QD (a combination of 10 mg of loratadine in the coating and 240 mg of pseudoephedrine sulfate in an extended-release core) once daily, 10 mg of loratadine once daily, 120 mg of pseudoephedrine sulfate every 12 hours, or placebo for 2 weeks., Results: SCH 434 QD was consistently superior to placebo in controlling the symptoms of seasonal allergic rhinitis. Composite symptom scores (total, total nasal, and total nonnasal) were reduced significantly in patients treated with SCH 434 QD as compared with placebo (p < 0.01). When compared with its individual components, reductions in mean symptom scores were consistently greater, numerically, in patients treated with SCH 434 QD than in patients who were treated with either loratadine or pseudoephedrine alone. SCH 434 QD was superior to pseudoephedrine in reducing nonnasal symptoms at all time points (p < 0.01), and superior to loratadine in relieving nasal stuffiness at end point (p < 0.01). In the physicians' evaluation of therapeutic response, the SCH 434 QD group had the greatest number of patients with a good or excellent response at end point (58%). All treatments were generally well tolerated with no serious or unusual adverse events. Insomnia and nervousness, adverse events commonly associated with pseudoephedrine, were noted in a significantly greater number of patients treated with SCH 434 QD or pseudoephedrine (p < or = 0.04) as compared with those treated with loratadine or placebo., Conclusions: The results of the study demonstrate that SCH 434 QD is more effective than placebo or either of its components alone in the treatment of seasonal allergic rhinitis.
- Published
- 1995
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48. Use of ipratropium bromide nasal spray in chronic treatment of nonallergic perennial rhinitis, alone and in combination with other perennial rhinitis medications.
- Author
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Grossman J, Banov C, Boggs P, Bronsky EA, Dockhorn RJ, Druce H, Findlay SR, Georgitis JW, Hampel FC, and Kaiser H
- Subjects
- Adult, Aged, Drug Therapy, Combination, Drug Tolerance, Female, Glucocorticoids therapeutic use, Histamine H1 Antagonists therapeutic use, Humans, Ipratropium administration & dosage, Ipratropium adverse effects, Longitudinal Studies, Male, Middle Aged, Nasal Decongestants therapeutic use, Nasal Mucosa drug effects, Nebulizers and Vaporizers, Ipratropium therapeutic use, Rhinitis, Allergic, Perennial drug therapy
- Abstract
To study the long-term safety and effectiveness of ipratropium bromide nasal spray 0.03% in the treatment of nonallergic perennial rhinitis, we administered this medication for 1 year in an open-label trial involving 285 patients. Our intention was to maintain the highest protocol dose possible to gain a clearer picture of the long-term side effect profile of the compound. Ipratropium bromide was well tolerated with no serious side effects in this patient population. It provided a significant improvement in rhinorrhea throughout the year-long trial; only 17 of 285 patients (6%) were considered treatment failures. There was an improvement in patient quality of life, as well as a substantial reduction in the need for other medications (antihistamines, decongestants, and nasal steroids) used to treat perennial rhinitis symptoms.
- Published
- 1995
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49. A clinical trial of ipratropium bromide nasal spray in patients with perennial nonallergic rhinitis.
- Author
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Bronsky EA, Druce H, Findlay SR, Hampel FC, Kaiser H, Ratner P, Valentine MD, and Wood CC
- Subjects
- Adult, Double-Blind Method, Drug Tolerance, Female, Humans, Ipratropium adverse effects, Ipratropium therapeutic use, Male, Nasal Mucosa drug effects, Nebulizers and Vaporizers, Ipratropium administration & dosage, Rhinitis, Allergic, Perennial drug therapy
- Abstract
Intranasal ipratropium bromide has been shown to significantly reduce rhinorrhea. Use of a freon-propelled intranasal preparation has resulted in side effects associated with the drying properties of the propellant. The purpose of the present trial was to study the safety and efficacy of a new isotonic aqueous ipratropium bromide nasal spray pump, specifically in patients with perennial nonallergic rhinitis. Two hundred thirty-three patients participated in an 8-week double-blind parallel comparison of ipratropium bromide nasal spray with its vehicle, a saline solution. Treatment with the ipratropium spray resulted in a 30% reduction in rhinorrhea; this reduction was significantly greater than that seen with the saline vehicle. There was a modest reduction in postnasal drip, sneezing, and congestion with both treatments, which may be attributable to the salutary effects of the saline solution. Patients also perceived a significant reduction in the degree to which rhinorrhea interfered with their daily activities and moods. Treatment was well tolerated, with no drug-related systemic adverse events and no evidence of nasal rebound on discontinuation of treatment. Minor, infrequent episodes of nasal dryness and epistaxis were the only significant adverse events reported; these did not limit treatment.
- Published
- 1995
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50. Albuterol aerosol versus albuterol Rotacaps in exercise-induced bronchospasm in children.
- Author
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Bronsky EA, Spector SL, Pearlman DS, Justus SE, and Bishop AL
- Subjects
- Administration, Inhalation, Aerosols, Albuterol therapeutic use, Analysis of Variance, Asthma, Exercise-Induced physiopathology, Child, Child, Preschool, Cross-Over Studies, Double-Blind Method, Female, Forced Expiratory Volume drug effects, Humans, Male, Powders, Albuterol administration & dosage, Asthma, Exercise-Induced prevention & control
- Abstract
The purpose of this study was to determine the safety and effectiveness of albuterol aerosol 180 micrograms and albuterol powder 200 micrograms in the prevention of exercise-induced bronchospasm in children. Forty-six patients aged 4-11 years with asthma and exercise-induced bronchospasm were enrolled in this randomized, double-blind, single-dose, three-way crossover study comparing albuterol aerosol, albuterol powder, and placebo. Exercise challenge was performed at the screening visit for qualifying and baseline determinations of pulmonary function and then 15 min after drug administration at each of three visits. Prevention of exercise-induced bronchospasm was assessed by comparing across all treatment groups the percentage change in FEV1 from pre- to postexercise, the percentage of patients protected by treatment, postexercise minimum FEV1, and postexercise change in FEV1. Safety was assessed by observation of clinical adverse events, laboratory tests, physical examination, electrocardiogram and rhythm strips, vital signs, and pulmonary auscultation. Forty-four patients completed the study. Mean postexercise FEV1 decreased 6% from preexercise values when patients were treated with either albuterol formulation; FEV1 decreased 23% when patients were treated with placebo. Exercise-induced bronchospasm was prevented in 95% of patients when treated with albuterol powder, in 91% treated with albuterol aerosol, and in 57% treated with placebo. Patients maintained significantly higher mean minimum FEV1 values after treatment with albuterol powder and albuterol aerosol than when treated with placebo. Treatment with either albuterol formulation produced a significantly smaller decrease in mean FEV1 from pre- to postexercise than treatment with placebo. No drug-related adverse events were reported, and safety assessments were within normal limits.(ABSTRACT TRUNCATED AT 250 WORDS)
- Published
- 1995
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