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Objective: The clinical efficacy, tolerability and acceptability of a new multidose powder inhaler (MDPI) [Easyhaler, Orion Pharma, Finland] containing a high dose (500 µg/dose) of beclomethasone dipropionate (BDP) were compared with those of BDP metered dose inhaler administered with a large volume spacer (MDI-spacer). Patients and Study Design: Recruited patients were adult asthmatics currently receiving 800 to 1000 µg/day of inhaled corticosteroid. The dose of BDP during the study was 1000 mg/day. The study was an open, randomised, parallel-group multicentre study and included a 2-week run-in period followed by a 12-week treatment period. Results: 74 patients were randomised to both groups. During the run-in period the mean morning peak expiratory flow (PEF) was 489 and 478 L/min in the MDPI and MDI-spacer groups, respectively. During the last 2 weeks of the study the morning PEF was 485 L/min in the MDPI group and 477 L/min in the MDI-spacer group. Asthma symptom scores and use of rescue medication were low in both groups. The median dose of histamine required to decrease forced expiratory volume in 1 second (FEV) by 15% was 1.05mg in the MDPI group and 0.64mg in the MDI-spacer group. The most frequent adverse events were hoarseness and sore throat. Mean serum cortisol levels were not affected in either treatment group. Patients' personal opinion regarding acceptability of the devices clearly favoured the MDPI. Conclusion: In conclusion, the novel powder inhaler was well tolerated and at least equally effective compared with the conventional MDI-spacer combination in the treatment of asthma with BDP. However, in everyday use the patients clearly favoured the powder inhaler. [ABSTRACT FROM AUTHOR]

Background: An investigator-driven, real-life follow-up study of adult-onset steroid-naïve, newly diagnosed asthma (162 patients) to investigate the treatment results over the 25-year course of the disease and whether the first treatment year's forced expiratory volume in one second (FEV 1 ) predicts the long-term prognosis., Methods: Eighty-three per cent of the 133 living patients participated in the 25-year examinations. At this visit, basic asthma examinations including lung function, as well as questionnaires for health-related quality of life (HRQoL), GINA and the Asthma Control Test, were used for evaluation. The use of medication and remission was verified., Results: There was no statistically significant change in mean FEV 1 % predicted (FEV 1 %) from baseline to the 25-year control. The changes in FEV 1 % during the first year predicted the results at the end of follow-up. Normal FEV 1 % at the end of the first year predicted normal FEV 1 , and below-normal FEV 1 % at 1 year predicted below-normal FEV 1 % at 25 years. Twenty-nine patients (26.4%) had discontinued their medication, and six (5.5%) used ICS periodically. Clinical remission was reached by 16.4% of the patients, and 7.6% reached functional remission. The general HRQoL remained unchanged., Conclusion: In adult-onset asthma, the level of FEV 1 reached during the first treatment year seems to predict the later lung function level. One quarter of the patients discontinued the asthma treatment, but their HRQoL was better than that of those continuing to use ICS. Clinical remission was reached by 16% of the patients, which is in concordance with other studies., (© 2019 EAACI and John Wiley and Sons A/S. Published by John Wiley and Sons Ltd.)

Objective: We assessed the 10-year effectiveness of self-management guidance in a prospective follow-up study of patients with asthma when inhaled corticosteroids were used from the beginning in the treatment., Methods: Consecutive newly diagnosed asthmatics (n = 162) were randomized: 80 to an intervention group (IG) and 82 to a control group (CG). Lung function (LF), airway hyperresponsiveness (AHR), and health-related quality of life (HRQoL) were examined at 10 years., Results: The advantages of intensive education with regards to LF measured by forced expiratory volume in 1 second and forced vital capacity were seen only after the first year. Later, there were no statistically significant differences in any parameters between the groups. However, during 10-year follow-up, peak expiratory flow, AHR, and HRQoL improved significantly in both groups (no differences as regards gender, smoking, or atopy). At 10 years, 68% of the IG and 75% of the CG patients still showed AHR after histamine challenge. Generic HRQoL scores in both groups equaled that of the age-standardized group a general population but only 50% in the IG and 55% in the CG had normal disease-specific HRQoL scores. According to Global Initiative for Asthma (GINA) criteria 23% of patients in the IG and 25% in the CG had asthma under control., Conclusions: The effectiveness of intensive self-management education could be shown only in the short term. The groups did not differ significantly in any of the parameters investigated, and showed nearly normal LF and HRQoL. AHR improved only partly and only a minority of the patients had asthma under good control according to GINA criteria. This study showed that evaluation of asthma using LF alone does not show the whole truth about asthma treatment results. HRQoL should be used in conjunction with GINA criteria, to assess asthma treatment outcomes. The value and importance of AHR for the evaluation of treatment remains obscure.

The authors assessed the health effects of emission reduction of malodorous sulfur compounds in a prospective cohort study with a controlled natural experiment. A total of 810 subjects (83%) participated in the follow up: 316 from the severely polluted, 306 from the moderately polluted, and 188 from the nonpolluted communities. In the severely polluted community, the annual ambient air concentration of total reduced sulfur compounds decreased from 11 microg/m3 to 6 microg/m3. Compared with the nonpolluted community, the relative decrease in acute respiratory infections, adjusted for a change in smoking habits, was 0.53 episodes/person-year (95% confidence interval = 0.22, 0.83) in the severely polluted community and 0.36 episodes/person-year (95% confidence interval = 0.06, 0.66) in the moderately polluted community. In addition, the frequency of nasal symptoms (p = .004) and cough (p = .037) decreased significantly. The results are consistent with the hypothesis that exposure to malodorous sulfur compounds increases the risk of acute respiratory infections and symptoms of the respiratory tract.

Two types of health-related quality-of-life (HRQoL) index, the disease-specific St George's Respiratory Questionnaire (SGRQ) and the generic 15D, were compared for indication of HRQoL changes and correlation with clinical parameters in 157 newly diagnosed asthmatics. The asthmatics were treated with inhaled anti-inflammatory therapy. Measurements at baseline, and after one and three years treatment. Both HRQoL indices indicated a significant improvement in HRQoL during treatment. The changes in total HRQoL scores correlated moderately well. Changes in airway responsiveness correlated fairly well with those of the total SGRQ score (r = 0.29 between baseline and one yr treatment and 0.36 between baseline and three yrs treatment, p < 0.001) and with those of 15D (r = 0.21 between baseline and three yrs treatment; p < 0.05). This may indicate that airway hyperresponsiveness influences the personal assessment of HRQoL. On the other hand, the varying correlation between lung function and HRQoL scores may indicate that they measure largely unrelated factors. Both the disease-specific and the generic health-related quality-of-life indices changed with treatment and indicated an improved health-related quality-of-life for mild asthmatics during a three-year treatment.

Exposure to very low levels of ambient-air malodorous sulfur compounds and their effect on eye irritation, respiratory-tract symptoms, and central nervous system symptoms in adults were assessed. A cross-sectional self-administered questionnaire (response rate = 77%) was distributed during March and April 1992 to adults (n = 336) who lived in a neighborhood that contained a pulp mill and in a nonpolluted reference community (n = 380). In the exposed community, the measured annual mean concentrations of total reduced sulfur compounds and sulfur dioxide measured in two stations were 2 to 3 micrograms/m3 and 1 micrograms/m3, respectively. In the reference community, the annual mean concentration of sulfur dioxide was 1 micrograms/m3. The residents of the community near the pulp mill reported an excess of cough, respiratory infections, and headache during the previous 4 wk, as well as during the preceding 12 mo. The relative risk for headache was increased significantly in the exposed community, compared with the reference area: the adjusted odds ratio (aOR) was 1.83 (95% confidence interval [95% CI] = 1.06-3.15] during the previous 4 wk and 1.70 (95% CI = 1.05-2.73) during the preceding 12 mo. The relative risk for cough was also increased during the preceding 12 mo (aOR = 1.64, 95% CI = 1.01-2.64). These results indicated that adverse health effects of malodorous sulfur compounds occur at lower concentrations than reported previously.

The paper mills in South Karelia, the southeast part of Finland, are responsible for releasing a substantial amount of malodorous sulfur compounds such as hydrogen sulfide (H2S), methyl mercaptan (CH3SH), and methyl sulfides [(CH3)2S and (CH3)2S2], into ambient air. In the most polluted residential area the annual mean concentrations of hydrogen sulfide and methyl mercaptan are estimated to be 8 and 2 to 5 micrograms/m3 and the highest daily average concentration 100 and 50 micrograms/m3. The annual mean and highest daily concentrations of sulfur dioxide (SO2) are very low. We studied the effects of malodorous sulfur compounds on eye, nasal and respiratory symptoms, and headache in adults. A cross-sectional self-administered questionnaire was distributed in February 1987 and responded to by 488 adults living in a severely (n = 198), a moderately (n = 204), and a nonpolluted community (n = 86). This included questions about occurrence of the symptoms of interest during the previous 4 wk and 12 months and individual, behavioral, and other environmental determinants of the symptoms. The response rate was 83%. The odds ratios (OR) for symptoms experienced often or constantly in severely versus nonpolluted and moderately versus nonpolluted communities were estimated in logistic regression analysis controlling potential confounders. The odds ratios for eye (moderate exposure OR 11.70, Cl95% 2.33 to 58.65; severe exposure OR 11.78, Cl95% 2.35 to 59.09) and nasal symptoms (OR 2.01, Cl95% 0.97 to 4.15; OR 2.19, Cl95% 1.06 to 4.55) and cough (OR 1.89, Cl95% 0.61 to 5.86; OR 3.06, Cl95% 1.02 to 9.29) during the previous 12 months were increased, with a dose-response pattern.(ABSTRACT TRUNCATED AT 250 WORDS)

192 patients, most of them ambulatory, with acute exacerbation of chronic bronchitis were treated with 10- to 14-day courses of oral ofloxacin receiving 400 mg once daily or doxycycline first 200 mg and then 100 mg once daily in this randomized observer-blinded multicentre study. 98 patients were included in the ofloxacin group and 94 in the doxycycline group. The clinical efficacy was 86/87 (98.8%) in the ofloxacin group and 87/91 (91.2%) in the doxycycline group. The bacteriological efficacy was 31/34 (91.2%) in the ofloxacin group and 19/24 (79.2%) in the doxycycline group. Some patients had more than one pathogen. There was no statistically significant difference in efficacy between the two treatment groups; both treatments were highly effective and well tolerated. The adverse events showed an expected pattern. Ofloxacin treatment was discontinued in three patients. In conclusion, both treatments were found to have similar safety and efficacy and were well tolerated when used for treatment of acute exacerbations of chronic bronchitis.

Immunotherapy with a dialysed aqueous extracted alum absorbed extract of grass pollens and with undialysed pyridine extracted alum precipitated extract of grass pollens (Allpyral) was compared in 58 patients with hay fever over a three year period in a randomized open study. Both types of treatment resulted in similar immunological responses as measured by changes in grass specific serum IgE and IgG. The dialysis of the grass pollen material did not decrease or increase the stimulation of specific immunoglobulins. The incidence of both local and systemic side effects was similar in both treatments. More injection site granulomata occurred in patients treated with the new alum adsorbed extract, although the difference did not achieve statistical significance. Symptom-medication data showed that patients who received the conventional pyridine extracted materials obtained a better clinical response, but all treatments gave continuing clinical benefit in each successive year.

We studied the clinical effect of a combination aerosol containing salbutamol and beclomethasone dipropionate in comparison to doubling the standard dose of salbutamol from an inhaler. Fifty-seven patients completed the double-blind, crossover study. They were treated with either an aerosol of 100 micrograms beclomethasone dipropionate and 200 micrograms salbutamol or 400 micrograms salbutamol alone. Both regimens were administered four times a day for 4 weeks. The patients showed significant improvement in FEV1, PEFR, and symptom scores after treatment with beclomethasone dipropionate and salbutamol compared with pre-trial values and with treatment with double the dose of salbutamol. The patients demonstrated a clear preference for treatment with the combination of beclomethasone dipropionate and salbutamol. Regular treatment with beclomethasone dipropionate in addition to salbutamol as a combination inhaler provides much better control of asthma than merely increasing the dose of salbutamol in those patients poorly controlled on standard doses of inhaled bronchodilators.

In a double-blind, cross-over trial comprising 19 adult asthmatic patients a sustained-release preparation of theophylline (Theo-Dur), given twice daily, was compared with a conventional fast-release preparation (Nuelin), given three times daily. The theophylline doses were individually titrated to give plasma concentrations in the lower region of the therapeutic interval. The sustained-release preparation gave higher morning theophylline concentrations than the fast-release preparation (9.2 vs 5.9 mg/l). This resulted in somewhat higher morning peak flow values during Theo-Dur treatment. However, the difference in asthma symptoms was not significant and the patients showed no preference for either preparation. We conclude that the advantage of a sustained-release preparation over a conventional fast-release theophylline preparation is the lower dosing frequency rather than the better clinical effect in patients who suffer from chronic asthma, but whose disease is in a relatively stable phase.