Double-blind multicenter controlled clinical study comparing the efficacy of picumast dihydrochloride versus astemizole and placebo in patients with seasonal allergic rhinitis.
The efficacy of picumast dihydrochloride (3,4-dimethyl-7-[ 4-(4-chlorobenzyl)piperazine-1-yl]propoxycoumarine dihydrochloride) in a dosage of 2 mg o.d. vs. astemizole (10 mg o.d.) and placebo was investigated in a double-blind, controlled multicenter study. During the first 3 days of treatment, the patients were administered double their assigned dose as loading dose. A total of 119 patients were enrolled in the study, of whom 103 were evaluable for efficacy (picumast dihydrochloride n = 35, astemizole n = 35 and placebo n = 33). The primary objective was the number of patients for whom the investigator scored the effectiveness of study medication as adequate or better over a treatment period lasting at least 4 days. A statistically significantly improved efficacy over placebo was demonstrated by picumast dihydrochloride in terms of the primary objective as was a trend to improved efficacy over astemizole. Observation of the length of participation of the patients in the study up to the point of premature stopping due to inadequate efficacy, adverse events or non-compliance demonstrated that clearly more patients in both active drug groups remained in the study over the planned duration of 28 days compared with patients in the placebo group. In this respect, more patients on astemizole dropped out of the study prematurely compared with patients on picumast dihydrochloride. Serious adverse events did not occur.(ABSTRACT TRUNCATED AT 250 WORDS)
Franke
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Clinical Research of Boehringer Mannheim GmbH, Fed. Rep. of Germany.
Messinger
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D000328:Adult; D000368:Aged; D016589:Astemizole; D001562:Benzimidazoles / Q000009:adverse effects / Q000627:therapeutic use*; D003374:Coumarins / Q000009:adverse effects / Q000627:therapeutic use*; D004311:Double-Blind Method; D006634:Histamine H1 Antagonists / Q000009:adverse effects / Q000627:therapeutic use*; D006801:Humans; D008875:Middle Aged; D015337:Multicenter Studies as Topic; D010349:Patient Compliance; D016032:Randomized Controlled Trials as Topic; D006255:Rhinitis, Allergic, Seasonal / Q000188:drug therapy* / Q000503:physiopathology
D001562:Benzimidazoles; D003374:Coumarins; D006634:Histamine H1 Antagonists; C013373:picumast; D016589:Astemizole