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1. Effect of Inhaled Corticosteroid Withdrawal on Chronic Obstructive Pulmonary Disease Exacerbations in Patients Taking Triple Therapy at Baseline

Author

Ferguson GT, Shaikh A, Tetzlaff K, Mueller A, Magnussen H, and Watz H

Subjects
copd, dual bronchodilator, glucocorticoid, triple therapy, Diseases of the respiratory system, RC705-779
Abstract

Gary T Ferguson,1 Asif Shaikh,2 Kay Tetzlaff,3 Achim Mueller,3 Helgo Magnussen,4 Henrik Watz4 1Pulmonary Research Institute of Southeast Michigan, Farmington Hills, MI, USA; 2Boehringer Ingelheim Pharmaceuticals, Inc, Ridgefield, CT, USA; 3Boehringer Ingelheim Pharma GmbH & Co. KG, Biberach an der Riss, Germany; 4Pulmonary Research Institute at Lung Clinic Grosshansdorf, Airway Research Center North (ARCN), German Center for Lung Research (DZL), Grosshansdorf, GermanyCorrespondence: Gary T FergusonPulmonary Research Institute of Southeast Michigan, Suite A, 29255 W 10 Mile Road, Farmington Hills, MI, USATel +1 248-478-6561Fax +1 248-478-6908Email garytferguson@msn.comPurpose: In the Withdrawal of Inhaled Steroids during Optimized Bronchodilator Management (WISDOM) trial, inhaled corticosteroid (ICS) withdrawal in patients with chronic obstructive pulmonary disease receiving triple therapy (long-acting β2-agonist+long-acting muscarinic antagonist+ICS) did not change moderate/severe exacerbation risk. However, many patients were not taking triple therapy before study participation. This analysis was conducted to eliminate the impact of non-ICS users on WISDOM results by re-analyzing the data using only the subset of patients who were taking triple therapy at screening.Patients and Methods: The effect of ICS withdrawal on moderate/severe exacerbation risk in the subgroup of WISDOM patients taking triple therapy before enrolling in the study was evaluated in this post hoc analysis. Additionally, the effect of ICS withdrawal in patients with a history of ≥ 2 exacerbations in the previous year and various blood eosinophil counts was assessed.Results: Overall, 39.0% (n=970: ICS continuation, 479; ICS withdrawal, 491) of the WISDOM trial population were taking triple therapy at screening. Baseline characteristics were generally similar between groups. Moderate/severe exacerbation risk between the ICS withdrawal and continuation groups (hazard ratio [HR], 1.05; 95% confidence interval [CI]: 0.89– 1.25) was not increased in patients taking triple therapy at screening versus the overall trial population (HR [95% CI]: 1.06 [0.94– 1.19]). However, in patients with a history of ≥ 2 exacerbations, exacerbation risk (HR [95% CI]) increased nominally with blood eosinophil count from 1.07 [0.81– 1.41] (≥ 100 cells/μL) to 1.45 [0.58– 3.60] (≥ 400 cells/μL).Conclusion: Consistent with results from the overall WISDOM trial population, ICS withdrawal did not increase exacerbation risk in patients taking triple therapy at screening. Patients with a history of frequent exacerbations and higher blood eosinophil counts could benefit from continuation of ICS-based therapy.Keywords: COPD, dual bronchodilator, glucocorticoid, triple therapy

Published
2020

2. Determinants of exacerbation risk in patients with COPD in the TIOSPIR study

Author

Calverley PMA, Tetzlaff K, Dusser D, Wise RA, Mueller A, Metzdorf N, and Anzueto A

Subjects
COPD, exacerbation, frequent exacerbators, Diseases of the respiratory system, RC705-779
Abstract

Peter MA Calverley,1 Kay Tetzlaff,2 Daniel Dusser,3 Robert A Wise,4 Achim Mueller,5 Norbert Metzdorf,2 Antonio Anzueto6 1Clinical Science Centre, Institute of Ageing and Chronic Disease, University of Liverpool, Liverpool, UK; 2Respiratory Medicine, Boehringer Ingelheim Pharma GmbH, Ingelheim am Rhein, Germany; 3Department of Pneumology, Hôpital Cochin, Université Paris Descartes, Sorbonne Paris Cité, Paris, France; 4Division of Pulmonary and Critical Care Medicine, Department of Medicine, Johns Hopkins University School of Medicine, Baltimore, MD, USA; 5Biostatistics and Data Sciences Europe, Boehringer Ingelheim Pharma GmbH, Biberach an der Riss, Germany; 6Pulmonary Medicine and Critical Care, University of Texas Health Sciences Center and South Texas Veterans’ Health Care System, San Antonio, TX, USA Background: Exacerbation history is used to grade the risk of COPD exacerbation, but its reliability and relationship to other risk factors and prior therapy is unclear. To examine these interrelationships, we conducted a post hoc analysis of patients in the TIOSPIR trial with ≥2 years’ follow-up or who died on treatment.Patients and methods: Patients were grouped by their annual exacerbation rate on treatment into nonexacerbators, infrequent, and frequent exacerbators (annual exacerbation rates 0, ≤1, and >1, respectively), and baseline characteristics discriminating among the groups were determined. We used univariate and multivariate analyses to explore the effect of baseline characteristics on risk of exacerbation, hospitalization (severe exacerbation), and death (all causes).Results: Of 13,591 patients, 6,559 (48.3%) were nonexacerbators, 4,568 (33.6%) were infrequent exacerbators, and 2,464 (18.1%) were frequent exacerbators; 45% of patients without exacerbations in the previous year exacerbated on treatment. Multivariate analysis identified baseline pulmonary maintenance medication as a predictive factor of increased exacerbation risk, with inhaled corticosteroid treatment associated with increased exacerbation risk irrespective of exacerbation history.Conclusion: Our data confirm established risk factors for exacerbation, but highlight the limitations of exacerbation history when categorizing patients and the importance of prior treatment when identifying exacerbation risk. Keywords: COPD, exacerbation, frequent exacerbators

Published
2017

3. Daily home-based spirometry during withdrawal of inhaled corticosteroid in severe to very severe chronic obstructive pulmonary disease

Author

Rodriguez-Roisin R, Tetzlaff K, Watz H, Wouters EF, Disse B, Finnigan H, Magnussen H, and Calverley PM

Subjects
FEV1, home-based spirometry, inhaled corticosteroid, lung function, severe COPD, Diseases of the respiratory system, RC705-779
Abstract

Roberto Rodriguez-Roisin,1 Kay Tetzlaff,2,3 Henrik Watz,4 Emiel FM Wouters,5 Bernd Disse,2 Helen Finnigan,6 Helgo Magnussen,4 Peter MA Calverley7 1Respiratory Institute, Servei de Pneumologia, Hospital Clínic IDIBAPS-CIBERES, Universitat de Barcelona, Barcelona, Spain; 2Boehringer Ingelheim Pharma GmbH & Co. KG, Ingelheim, Germany; 3Department of Sports Medicine, University of Tübingen, Tübingen, Germany; 4Pulmonary Research Institute at Lung Clinic Grosshansdorf, Airway Research Center North, German Center for Lung Research, Grosshansdorf, Germany; 5Department of Respiratory Medicine, University Hospital Maastricht, Maastricht University, Maastricht, the Netherlands; 6Department of Biostatistics and Data Sciences, Boehringer Ingelheim, Bracknell, UK; 7Institute of Ageing and Chronic Disease, Aintree University Hospital, Liverpool, UK Abstract: The WISDOM study (NCT00975195) reported a change in lung function following withdrawal of fluticasone propionate in patients with severe to very severe COPD treated with tiotropium and salmeterol. However, little is known about the validity of home-based spirometry measurements of lung function in COPD. Therefore, as part of this study, following suitable training, patients recorded daily home-based spirometry measurements in addition to undergoing periodic in-clinic spirometric testing throughout the study duration. We subsequently determined the validity of home-based spirometry for detecting changes in lung function by comparing in-clinic and home-based forced expiratory volume in 1 second in patients who underwent stepwise fluticasone propionate withdrawal over 12 weeks versus patients remaining on fluticasone propionate for 52 weeks. Bland–Altman analysis of these data confirmed good agreement between in-clinic and home-based measurements, both across all visits and at the individual visits at study weeks 6, 12, 18, and 52. There was a measurable difference between the forced expiratory volume in 1 second values recorded at home and in the clinic (mean difference of -0.05 L), which may be due to suboptimal patient effort in performing unsupervised recordings. However, this difference remained consistent over time. Overall, these data demonstrate that home-based and in-clinic spirometric measurements were equally valid and reliable for assessing lung function in patients with COPD, and suggest that home-based spirometry may be a useful tool to facilitate analysis of changes in lung function on a day-to-day basis. Keywords: FEV1, home-based spirometry, inhaled corticosteroid, lung function, severe COPD

Published
2016

8. Nintedanib for Systemic Sclerosis-Associated Interstitial Lung Disease

Author

Distler, O, Highland, Kb, Gahlemann, M, Azuma, A, Fischer, A, Mayes, Md, Raghu, G, Sauter, W, Girard, M, Alves, M, Clerisme-Beaty, E, Stowasser, S, Tetzlaff, K, Kuwana, M, Maher, Tm, Bergna, M, Casado, G, Mannucci Walter, P, Proudman, S, Stevens, W, Thakkar, V, Troy, L, Loeffler-Ragg, J, Olschewski, H, Bondue, B, Houssiau, F, Smith, V, Wuyts, W, Johnson, S, Keystone, E, Khalidi, N, Levesque, M, Maturana Rozas, R, Silva Orellana, A, Huang, C, Li, J, Jiang, Z, Liu, Y, Xiao, W, Xu, J, Zeng, X, Zheng, Y, Zou, H, Becvar, R, Madsen, H, Søndergaard, K, Kilpeläinen, M, Myllärniemi, M, Agard, C, Allanore, Y, Bourdin, A, Cottin, V, Crestani, B, Diot, E, Dominique, S, Hachulla, E, Jouneau, S, Leroy, S, Nunes, H, Prevot, G, Wallaert, B, Wemeau, L, Aringer, M, Bewig, B, Blaas, S, Distler, J, Ehrchen, J, Ewert, R, Gläser, S, Henes, J, Hunzelmann, N, König, R, Kötter, I, Kreuter, M, Prasse, A, Schulze-Koops, H, Sfikakis, P, Vlachoyiannopoulos, P, Losonczy, G, Behera, D, Gayathri Devi HJ, Kadel, J, Kawedia, M, Kumar, D, Kumar, U, Lokhande, R, Malpani, A, Mohan, M, Nalawade, A, Parakh, U, Swarnakar, R, Shobha, V, Thangakunam, B, Udwadia, Z, Henry, M, O'Reilly, K, Balbir-Gurman, A, Kramer, M, Litinsky, I, Rosner, I, Cutolo, M, Gabrielli, A, Iaccarino, L, Pesci, A, Riccieri, V, Vettori, S, Funakubo, Y, Inoue, Y, Kawakami, A, Kawaguchi, Y, Kawamura, T, Kondoh, Y, Nanki, T, Nishioka, Y, Nozawa, K, Oguragawa, T, Okamoto, M, Sano, H, Sasai, R, Sasaki, N, Suda, T, Takahashi, H, Takeuchi, T, Tanaka, S, Yamasaki, Y, Ch'Ng, Ss, Cheah, C, Kan, S, Raja Mohamed RB, Selman, M, de Vries-Bouwstra JK, van den Toorn, L, Vonken, M, Voskuyl, Ae, Hoffmann-Vold, Am, Seip, M, Dankiewicz-Fares, I, Olesiejuk, R, Pulka, G, Szepietowski, J, Alves, J, Bernardes, M, Cordeiro, A, Costa, J, Neves, S, Salvador, Mj, Alegre Sancho, J, Carreira Delgado, P, Castellví Barranco, I, Cifrián Martínez, J, Guillén Del Castillo, A, Ovalles, Jg, López-Longo, Fj, Rivera Gallego, A, Freire Dapena MC, Román Ivorra JA, Ekwall, Ah, Maurer, B, Mihai, Cm, Müller, R, Mahakkanukrauh, A, Nantiruj, K, Siripaitoon, B, Denton, Cp, Herrick, A, Madhok, R, West, A, Bascom, R, Criner, G, Csuka, Me, Dematte D'Amico, J, Ettinger, N, Gerbino, A, Gerke, A, Glassberg, M, Glazer, C, Golden, J, Gripaldo, R, Gupta, N, Hamblin, M, Highland, K, Ho, L, Huggins, Jt, Hummers, L, Jones, L, Kahaleh, M, Khanna, D, Kim, H, Lancaster, Lh, Luckhardt, T, Mayes, M, Mendoza Ballesteros, F, Mooney, J, Mohabir, P, Morrissey, B, Moua, T, Padilla, M, Patel, N, Perez, R, Roman, J, Rossman, M, Russell, T, Saketkoo, L, Shah, A, Shlobin, O, Scholand, Mb, Simmssetts, R, Spiera, R, Steen, V, Veeraraghavan, S, Weigt, S., Distler, O, Highland, Kb, Gahlemann, M, Azuma, A, Fischer, A, Mayes, Md, Raghu, G, Sauter, W, Girard, M, Alves, M, Clerisme-Beaty, E, Stowasser, S, Tetzlaff, K, Kuwana, M, Maher, Tm, SENSCIS Trial Investigators., Bergna M, Casado, G, Mannucci Walter, P, Proudman, S, Stevens, W, Thakkar, V, Troy, L, Loeffler-Ragg, J, Olschewski, H, Bondue, B, Houssiau, F, Smith, V, Wuyts, W, Johnson, S, Keystone, E, Khalidi, N, Levesque, M, Maturana Rozas, R, Silva Orellana, A, Huang, C, Li, J, Jiang, Z, Liu, Y, Xiao, W, Xu, J, Zeng, X, Zheng, Y, Zou, H, Becvar, R, Madsen, H, Søndergaard, K, Kilpeläinen, M, Myllärniemi, M, Agard, C, Allanore, Y, Bourdin, A, Cottin, V, Crestani, B, Diot, E, Dominique, S, Hachulla, E, Jouneau, S, Leroy, S, Nunes, H, Prevot, G, Wallaert, B, Wemeau, L, Aringer, M, Bewig, B, Blaas, S, Distler, J, Ehrchen, J, Ewert, R, Gläser, S, Henes, J, Hunzelmann, N, König, R, Kötter, I, Kreuter, M, Prasse, A, Schulze-Koops, H, Sfikakis, P, Vlachoyiannopoulos, P, Losonczy, G, Behera, D, Gayathri Devi, Hj, Kadel, J, Kawedia, M, Kumar, D, Kumar, U, Lokhande, R, Malpani, A, Mohan, M, Nalawade, A, Parakh, U, Swarnakar, R, Shobha, V, Thangakunam, B, Udwadia, Z, Henry, M, O'Reilly, K, Balbir-Gurman, A, Kramer, M, Litinsky, I, Rosner, I, Cutolo, M, Gabrielli, A, Iaccarino, Laura, Pesci, A, Riccieri, V, Vettori, S, Funakubo, Y, Inoue, Y, Kawakami, A, Kawaguchi, Y, Kawamura, T, Kondoh, Y, Nanki, T, Nishioka, Y, Nozawa, K, Oguragawa, T, Okamoto, M, Sano, H, Sasai, R, Sasaki, N, Suda, T, Takahashi, H, Takeuchi, T, Tanaka, S, Yamasaki, Y, Ch'Ng, S, Cheah, C, Kan, S, Raja Mohamed, Rb, Selman, M, de Vries-Bouwstra, Jk, van den Toorn, L, Vonken, M, Voskuyl, Ae, Hoffmann-Vold, Am, Seip, M, Dankiewicz-Fares, I, Olesiejuk, R, Pulka, G, Szepietowski, J, Alves, J, Bernardes, M, Cordeiro, A, Costa, J, Neves, S, Salvador, Mj, Alegre Sancho, J, Carreira Delgado, P, Castellví Barranco, I, Cifrián Martínez, J, Guillén Del Castillo, A, Ovalles, Jg, López-Longo, Fj, Rivera Gallego, A, Freire Dapena, Mc, Román Ivorra, Ja, Ekwall, Ah, Maurer, B, Mihai, Cm, Müller, R, Mahakkanukrauh, A, Nantiruj, K, Siripaitoon, B, Denton, Cp, Herrick, A, Madhok, R, West, A, Bascom, R, Criner, G, Csuka, Me, Dematte D'Amico, J, Ettinger, N, Gerbino, A, Gerke, A, Glassberg, M, Glazer, C, Golden, J, Gripaldo, R, Gupta, N, Hamblin, M, Highland, K, Ho, L, Huggins, Jt, Hummers, L, Jones, L, Kahaleh, M, Khanna, D, Kim, H, Lancaster, Lh, Luckhardt, T, Mayes, M, Mendoza Ballesteros, F, Mooney, J, Mohabir, P, Morrissey, B, Moua, T, Padilla, M, Patel, N, Perez, R, Roman, J, Rossman, M, Russell, T, Saketkoo, L, Shah, A, Shlobin, O, Scholand, Mb, Simmssetts, R, Spiera, R, Steen, V, Veeraraghavan, S, Weigt, S., National Institute for Health Research, British Lung Foundation, University of Zurich, and Distler, Oliver

Subjects
Male, Vital capacity, Indoles, Vital Capacity, Administration, Oral, 2700 General Medicine, 030204 cardiovascular system & hematology, Pulmonary function testing, law.invention, oral, Idiopathic pulmonary fibrosis, chemistry.chemical_compound, 0302 clinical medicine, Randomized controlled trial, law, SENSCIS Trial Investigators, CYCLOPHOSPHAMIDE, Clinical endpoint, scleroderma, 030212 general & internal medicine, Enzyme Inhibitors, 11 Medical and Health Sciences, lung diseases, Lung Diseases, Interstitial -- drug therapy -- etiology -- physiopathology, 10051 Rheumatology Clinic and Institute of Physical Medicine, General Medicine, respiratory system, Sciences bio-médicales et agricoles, Middle Aged, Protein-Tyrosine Kinases, MANIFESTATIONS, Disease Progression, Nintedanib, Female, TYROSINE KINASE INHIBITOR, Life Sciences & Biomedicine, CLINICAL-TRIALS, Adult, Diarrhea, medicine.medical_specialty, FIBROBLASTS, 610 Medicine & health, Placebo, administration, behavioral disciplines and activities, 03 medical and health sciences, FEV1/FVC ratio, Medicine, General & Internal, Double-Blind Method, Internal medicine, General & Internal Medicine, Enzyme Inhibitors -- adverse effects -- therapeutic use, SCORE, medicine, Humans, Indoles -- adverse effects -- therapeutic use, Scleroderma, Systemic -- complications -- drug therapy, Science & Technology, Scleroderma, Systemic, Protein-Tyrosine Kinases -- antagonists & inhibitors, business.industry, MORTALITY, interstitial, PULMONARY-FUNCTION, systemic, STANDARDIZATION, medicine.disease, EFFICACY, respiratory tract diseases, body regions, chemistry, adult, diarrhea, disease progression, double-blind method, enzyme inhibitors, female, humans, indoles, lung diseases, interstitial, male, middle aged, protein-tyrosine kinases, scleroderma, systemic, vital capacity, business, Lung Diseases, Interstitial, Diarrhea -- chemically induced
Abstract

Interstitial lung disease (ILD) is a common manifestation of systemic sclerosis and a leading cause of systemic sclerosis-related death. Nintedanib, a tyrosine kinase inhibitor, has been shown to have antifibrotic and antiinflammatory effects in preclinical models of systemic sclerosis and ILD., info:eu-repo/semantics/published

Published
2019

16. Nintedanib in progressive fibrosing interstitial lung diseases

Author

Flaherty, K. R., Wells, A. U., Cottin, V., Devaraj, A., Walsh, S. L. F., Inoue, Y., Richeldi, Luca, Kolb, M., Tetzlaff, K., Stowasser, S., Coeck, C., Clerisme-Beaty, E., Rosenstock, B., Quaresma, M., Haeufel, T., Goeldner, R. -G., Schlenker-Herceg, R., Brown, K. K., Richeldi L. (ORCID:0000-0001-8594-1448), Flaherty, K. R., Wells, A. U., Cottin, V., Devaraj, A., Walsh, S. L. F., Inoue, Y., Richeldi, Luca, Kolb, M., Tetzlaff, K., Stowasser, S., Coeck, C., Clerisme-Beaty, E., Rosenstock, B., Quaresma, M., Haeufel, T., Goeldner, R. -G., Schlenker-Herceg, R., Brown, K. K., and Richeldi L. (ORCID:0000-0001-8594-1448)

Abstract

BACKGROUND Preclinical data have suggested that nintedanib, an intracellular inhibitor of tyrosine kinases, inhibits processes involved in the progression of lung fibrosis. Although the efficacy of nintedanib has been shown in idiopathic pulmonary fibrosis, its efficacy across a broad range of fibrosing lung diseases is unknown. METHODS In this double-blind, placebo-controlled, phase 3 trial conducted in 15 countries, we randomly assigned patients with fibrosing lung disease affecting more than 10% of lung volume on high-resolution computed tomography (CT) to receive nintedanib at a dose of 150 mg twice daily or placebo. All the patients met criteria for progression of interstitial lung disease in the past 24 months despite treatment and had a forced vital capacity (FVC) of at least 45% of the predicted value and a diffusing capacity of the lung for carbon monoxide ranging from 30 to less than 80% of the predicted value. Randomization was stratified according to the fibrotic pattern (a pattern of usual interstitial pneumonia [UIP] or other fibrotic patterns) on high-resolution CT. The primary end point was the annual rate of decline in the FVC, as assessed over a 52-week period. The two primary populations for analysis were the overall population and patients with a UIP-like fibrotic pattern. RESULTS A total of 663 patients were treated. In the overall population, the adjusted rate of decline in the FVC was −80.8 ml per year with nintedanib and −187.8 ml per year with placebo, for a between-group difference of 107.0 ml per year (95% confidence interval [CI], 65.4 to 148.5; P<0.001). In patients with a UIP-like fibrotic pattern, the adjusted rate of decline in the FVC was −82.9 ml per year with nintedanib and −211.1 ml per year with placebo, for a difference of 128.2 ml (95% CI, 70.8 to 185.6; P<0.001). Diarrhea was the most common adverse event, as reported in 66.9% and 23.9% of patients treated with nintedanib and placebo, respectively. Abnormalities on liver

Published
2019

21. Short- and long-term effects of diving on pulmonary function

Author

Tetzlaff, K, Thomas, PS, Tetzlaff, K, and Thomas, PS

Abstract

© ERS 2017. The diving environment provides a challenge to the lung, including exposure to high ambient pressure, altered gas characteristics and cardiovascular effects on the pulmonary circulation. Several factors associated with diving affect pulmonary function acutely and can potentially cause prolonged effects that may accumulate gradually with repeated diving exposure. Evidence from experimental deep dives and longitudinal studies suggests long-term adverse effects of diving on the lungs in commercial deep divers, such as the development of small airways disease and accelerated loss of lung function. In addition, there is an accumulating body of evidence that diving with self-contained underwater breathing apparatus (scuba) may not be associated with deleterious effects on pulmonary function. Although changes in pulmonary function after single scuba dives have been found to be associated with immersion, ambient cold temperatures and decompression stress, changes in lung function were small and suggest a low likelihood of clinical significance. Recent evidence points to no accelerated loss of lung function in military or recreational scuba divers over time. Thus, the impact of diving on pulmonary function largely depends on factors associated with the individual diving exposure. However, in susceptible subjects clinically relevant worsening of lung function may occur even after single shallow-water scuba dives.

Published
2017

22. The 6-minute walk test as a COPD stratification tool: insights from the COPD biomarker qualification consortium

Author

Celli, B, Tetzlaff, K, Criner, G, Polkey, MI, Sciurba, F, Casaburi, R, Tal-Singer, R, Kawata, A, Merrill, D, Rennard, S, and COPD Biomarker Qualification Consortium

Subjects
Male, Consensus Development Conferences as Topic, Respiratory System, Walk Test, COPD Biomarker Qualification Consortium, Outcomes, REFERENCE EQUATIONS, EXERCISE CAPACITY, chronic obstructive pulmonary disease, Pulmonary Disease, Chronic Obstructive, Critical Care Medicine, Predictive Value of Tests, General & Internal Medicine, Functional evaluation, 6-MIN WALK DISTANCE, Humans, COPD, Aged, CLINICALLY IMPORTANT DIFFERENCE, HEALTH-STATUS, Science & Technology, 6-minute-walk distance, Reproducibility of Results, 11 Medical And Health Sciences, Middle Aged, PROGNOSTIC VALUE, CHRONIC LUNG-DISEASE, FUNCTIONAL STATUS, Female, INDIVIDUAL PARTICIPANT DATA, Life Sciences & Biomedicine, Biomarkers, CHRONIC RESPIRATORY-DISEASE
Abstract

BACKGROUND: The 6-minute walk test distance (6MWD) predicts mortality in COPD. Whether variability in study type (observational versus interventional), region performed limits use of the test as a stratification tool or outcome measure for therapeutic trials is unclear. METHODS: Original data from 14,497 COPD patients from 6 observational (n = 9641) and 5 interventional (n=4856) studies larger than 100 patients and longer than 6 months in duration were included. The geographical, anthropometrics, FEV1, dyspnea, co-morbidities and health status scores were measured. Associations between 6MWD with mortality, hospitalizations and exacerbations adjusted by study type, age and gender were evaluated. Thresholds for outcome prediction were calculated using receiver-operating curves. The change in 6MWD after inhaled bronchodilator treatment and surgical lung volume reduction (LVRS) were analyzed to evaluate the responsiveness of the test as an outcome measure. RESULTS: The 6MWD was significantly lower in non-survivors, those hospitalized or who exacerbated compared with those without events at 6, 12 and > 12 months. At these time points, the 6MWD ROC-AUC to predict mortality was 0.71, 0.70 and 0.68 and for hospitalizations was 0.61, 0.60 and 0.59. After treatment, the 6MWD was not different between placebo or bronchodilators but increased after LVRS compared with medical therapy. Variation across study types (observational or therapeutic) or regions did not confound the ability of 6MWD to predict outcome. CONCLUSIONS: The 6MWD may help stratify COPD patients for clinical trials and interventions aimed at modifying exacerbations, hospitalizations or death.

Published
2016

28. Withdrawal of inhaled glucocorticoids and exacerbations of COPD

Author

Magnussen, H., Disse, B., Rodriguez-Roisin, R., Kirsten, A., Watz, H., Tetzlaff, K., Towse, L., Finnigan, H., Dahl, R., Decramer, M., Chanez, P., Wouters, E.F.M., WISDOM Investigators, the, Calverley, P.M.A., Pulmonologie, RS: CAPHRI School for Public Health and Primary Care, RS: NUTRIM - R3 - Chronic inflammatory disease and wasting, RS: CAPHRI - Asthma and COPD, and Universitat de Barcelona

Subjects
Male, Spirometry, Exacerbation, Scopolamine Derivatives, CORTICOSTEROIDS, OBSTRUCTIVE PULMONARY-DISEASE, Fluticasone propionate, ISOLDE, Pulmonary Disease, Chronic Obstructive, SALMETEROL, Double-Blind Method, Forced Expiratory Volume, Administration, Inhalation, medicine, Humans, Albuterol, Chronic obstructive pulmonary diseases, Glucocorticoids, Malalties pulmonars obstructives cròniques, Aged, Proportional Hazards Models, Fluticasone, COPD, medicine.diagnostic_test, FLUTICASONE PROPIONATE, business.industry, Adrenocortical hormones, General Medicine, Tiotropium bromide, Middle Aged, RANDOMIZED CONTROLLED-TRIAL, medicine.disease, Corticosteroides, PREVENTION, Bronchodilator Agents, respiratory tract diseases, Androstadienes, Withholding Treatment, Estudi de casos, Anesthesia, Drug Therapy, Combination, Female, Salmeterol, Case studies, business, TIOTROPIUM, Glucocorticoid, medicine.drug
Abstract

BACKGROUND: Treatment with inhaled glucocorticoids in combination with long-acting bronchodilators is recommended in patients with frequent exacerbations of severe chronic obstructive pulmonary disease (COPD). However, the benefit of inhaled glucocorticoids in addition to two long-acting bronchodilators has not been fully explored.METHODS: In this 12-month, double-blind, parallel-group study, 2485 patients with a history of exacerbation of COPD received triple therapy consisting of tiotropium (at a dose of 18 μg once daily), salmeterol (50 μg twice daily), and the inhaled glucocorticoid fluticasone propionate (500 μg twice daily) during a 6-week run-in period. Patients were then randomly assigned to continued triple therapy or withdrawal of fluticasone in three steps over a 12-week period. The primary end point was the time to the first moderate or severe COPD exacerbation. Spirometric findings, health status, and dyspnea were also monitored.RESULTS: As compared with continued glucocorticoid use, glucocorticoid withdrawal met the prespecified noninferiority criterion of 1.20 for the upper limit of the 95% confidence interval (CI) with respect to the first moderate or severe COPD exacerbation (hazard ratio, 1.06; 95% CI, 0.94 to 1.19). At week 18, when glucocorticoid withdrawal was complete, the adjusted mean reduction from baseline in the trough forced expiratory volume in 1 second was 38 ml greater in the glucocorticoid-withdrawal group than in the glucocorticoid-continuation group (PCONCLUSIONS: In patients with severe COPD receiving tiotropium plus salmeterol, the risk of moderate or severe exacerbations was similar among those who discontinued inhaled glucocorticoids and those who continued glucocorticoid therapy. However, there was a greater decrease in lung function during the final step of glucocorticoid withdrawal. (Funded by Boehringer Ingelheim Pharma; WISDOM ClinicalTrials.gov number, NCT00975195.).

Published
2014
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37. Once-daily tiotropium and olodaterol fixed-dose combination via the Respimat improves outcomes vs mono-components in COPD in two 1-year studies

Author

Buhl, R, primary, Derom, E, additional, Ferguson, G, additional, Maltais, F, additional, Pizzichini, E, additional, Reid, J, additional, Watz, H, additional, Groenke, L, additional, Hamilton, A, additional, Tetzlaff, K, additional, Korducki, L, additional, Huisman, H, additional, Waitere-Wijker, S, additional, and Bateman, E, additional

Published
2015
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38. The impact of stepwise withdrawal of inhaled corticosteroids on lung function in COPD patients receiving dual bronchodilation: WISDOM study

Author

Watz, H, primary, Calverley, P, additional, Chanez, P, additional, Dahl, R, additional, Decramer, M, additional, Disse, B, additional, Finnigan, H, additional, Kirsten, AM, additional, Rodriguez-Roisin, R, additional, Tetzlaff, K, additional, Towse, L, additional, Wouters, E, additional, and Magnussen, H, additional

Published
2015
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39. Safety of once-daily tiotropium and olodaterol fixed-dose combination via the Respimat in chronic obstructive pulmonary disease in two 1-year studies

Author

Buhl, R, primary, Abrahams, R, additional, Bjermer, L, additional, Derom, E, additional, Fležar, M, additional, Hébert, J, additional, Veale, A, additional, Groenke, L, additional, Hamilton, A, additional, Tetzlaff, K, additional, Korducki, L, additional, Huisman, H, additional, Waitere-Wijker, S, additional, and McGarvey, L, additional

Published
2015
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41. The impact of stepwise withdrawal of inhaled corticosteroids on exacerbations in COPD patients receiving dual bronchodilation: WISDOM study

Author

Magnussen, H, primary, Chanez, P, additional, Dahl, R, additional, Decramer, M, additional, Disse, B, additional, Finnigan, H, additional, Kirsten, AM, additional, Rodriguez-Roisin, R, additional, Tetzlaff, K, additional, Towse, L, additional, Watz, H, additional, Wouters, E, additional, and Calverley, P, additional

Published
2015
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42. L’administration une fois par jour d’une association fixe de tiotropium et d’olodatérol par Respimat a amélioré les résultats par rapport aux composants individuels dans les BPCO au cours de deux études d’un an

Author

Buhl, R., primary, Derom, E., additional, Ferguson, G., additional, Maltais, F., additional, Pizzichini, E., additional, Reid, J., additional, Watz, H., additional, Groenke, L., additional, Hamilton, A., additional, Tetzlaff, K., additional, Korducki, L., additional, Huisman, H., additional, Waitere-Wijker, S., additional, and Bateman, E., additional

Published
2015
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43. Safety and efficacy of an inhaled epidermal growth factor receptor inhibitor (BIBW 2948 BS) in chronic obstructive pulmonary disease

Author

Woodruff, P.G., Wolff, M., Hohlfelds, J.M., Krug, N., Dransfield, M.T., Sutherland, E.R., Criner, G.J., Kim, V., Prasse, A., Nivens, M.C., Tetzlaff, K., Heilker, R., Fahy, J.V., and Publica

Subjects
mucin, chronic obstructive, chronic bronchitis, epidermal growth factor receptor, pulmonary disease
Abstract

Rationale Epidermal growth factor receptor (EGFR) activation is implicated in mucin hypersecretion in chronic obstructive pulmonary disease (COPD). Objectives: To investigate the safety and efficacy of an inhaled EGFR antagonist (BIBW 2948) in COPD. Methods: Multicenter, double-blind, placebo-controlled trial of 4 weeks of treatment with two doses of BIBW 2948 (15 and 30 mg twice a day) on safety and mucin-related outcomes in 48 patients with COPD. The effect of BIBW 2948 on EGFR activation in airway epithelial cells was assessed using an ex vivo assay. Efficacy measures included the volume of mucin in the airway epithelium (Vs mu,bala) in bronchial biopsies and the expression of mucin genes in bronchial brushings. Measurements and Main Results: Inhaled BIBW 2948 induced a dose-related inhibition of EGFR internalization (reflecting decreased EGFR activation) in epithelial cells from treated subjects. However, BIBW 2948 was associated with a dose-related increase in adverse events, including reversible liver enzyme elevation (n = 2), and reduction in FEV1. The changes in mucin stores and mucin gene expression were not significantly different in the pooled BIBW 2948 group versus placebo (volume of mucin per surface area of basal lamina = 0.22 +/- 7.11 vs. 0.47 +/- 8.06 mu m(3)/mu m(2); P = 0.93). However, in the 30 mg twice a day group, the reduction in epithelial mucin stores was greatest in subjects with the greatest degree of EGFR inhibition (Pearson r = 0.98; 95% confidence interval, 0.71-0.99). Conclusions: Four-week treatment with BIBW 2948 did not significantly decrease epithelial mucin stores and was poorly tolerated in patients with COPD. Ex vivo analyses suggest that higher doses may be more effective at both EGFR inhibition and decreases in mucin stores but that adverse events should be expected. Clinical trial registered with www.clinicaltrials.gov (NCT00423137).

Published
2010

45. P256 Safety Of Once-daily Tiotropium And Olodaterol Fixed-dose Combination Via The Respimat In Chronic Obstructive Pulmonary Disease In Two 1-year Studies

Author

Buhl, R., primary, Abrahams, R., additional, Bjermer, L., additional, Derom, E., additional, Fle ar, M., additional, Hebert, J., additional, Veale, A., additional, Gronke, L., additional, Hamilton, A., additional, Tetzlaff, K., additional, Korducki, L., additional, Huisman, H., additional, Waitere-Wijker, S., additional, and McGarvey, L., additional

Published
2014
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46. P254 Once-daily Tiotropium And Olodaterol Fixed-dose Combination Via The Respimat(R) Improves Outcomes Versus Mono-components In Copd In Two 1-year Studies

Author

Buhl, R., primary, Derom, E., additional, Ferguson, G., additional, Pizzichini, E., additional, Reid, J., additional, Watz, H., additional, Gronke, L., additional, Hamilton, A., additional, Tetzlaff, K., additional, Korducki, L., additional, Huisman, H., additional, Waitere-Wijker, S., additional, and Maltais, F., additional

Published
2014
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48. Effects of FLIRT on Bubble Growth in Man

Author

Winkler, B., additional, Koch, A., additional, Schoeppenthau, H., additional, Ludwig, T., additional, Tetzlaff, K., additional, Hartig, F., additional, Kaehler, W., additional, Koehler, A., additional, Kanstinger, A., additional, Ciscato, W., additional, and Muth, C.-M., additional

Published
2012
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