Efficacy and tolerability of picumast dihydrochloride in comparison with placebo in asthmatic patients.
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| Abstract |
In a randomized double-blind study, 107 patients with extrinisic, intrinsic or mixed bronchial asthma and impaired lung function received either picumast dihydrochloride (3,4-dimethyl-7-[4-(4-chlorobenzyl)piperazine-1-yl]propoxycoumarin dihydrochloride) 1 mg or placebo twice daily for 6 weeks after a 2-week placebo phase. Patients given picumast dihydrochloride demonstrated significant improvements compared with baseline in morning and evening peak flow and asthmatic symptoms like morning tightness, cough, dyspnoea, obstruction, number of asthma attacks during night and day, sum of asthmatic symptom scores, in vital capacity and Tiffeneau index, and a significant reduction of inhaled adjuvant medications. In contrast, placebo recipients improved significantly only in daytime asthma attacks, obstruction, sum of symptom scores, and Tiffeneau index. The differences between the picumast dihydrochloride and placebo groups significantly favoured picumast dihydrochloride for improvements in mean number of daytime asthma attacks, morning tightness, aerosol use and sum of symptom scores. Adverse reactions were minor and infrequent; no tiredness occurred with picumast dihydrochloride. Tolerability of both picumast dihydrochloride and placebo was rated as "good" to "very good" by patients and physicians.
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| Authors | D Boerner, K Metz, R Eberhardt |
| Journal | Arzneimittel-Forschung (Arzneimittelforschung) Vol. 39 Issue 10A Pg. 1363-7 (Oct 1989) ISSN: 0004-4172 [Print] Germany |
| PMID | 2576365 (Publication Type: Clinical Trial, Comparative Study, Journal Article, Randomized Controlled Trial) |
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