Efficacy and tolerability of picumast dihydrochloride in comparison with placebo in asthmatic patients.
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.
Boerner
D
D
Department of Product Development, Boehringer Mannheim GmbH, Fed. Rep. of Germany.
Metz
K
K
Eberhardt
R
R
D000328:Adult; D001249:Asthma / Q000188:drug therapy* / Q000503:physiopathology; D003374:Coumarins / Q000009:adverse effects / Q000627:therapeutic use*; D004311:Double-Blind Method; D005260:Female; D005541:Forced Expiratory Volume; D006634:Histamine H1 Antagonists / Q000009:adverse effects / Q000627:therapeutic use*; D006801:Humans; D008297:Male; D008875:Middle Aged; D016032:Randomized Controlled Trials as Topic
D003374:Coumarins; D006634:Histamine H1 Antagonists; C013373:picumast