A double-masked study was performed to investigate a possible side effect of the antiallergic substance Picumast dihydrochloride on lens transparency. 372 patients with Picumast dihydrochloride- or Ketotifen-treatment regularly underwent ophthalmologic examinations and Scheimpflug photography of the anterior eye segment. Results of slitlamp examinations as well as microdensitometric analyzes of the film negatives after one year treatment did not reveal any evidence that Picumast dihydrochloride compromised lens transparency in humans.

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Picumast dihydrochloride (Auteral), a new anti-allergic inhibitor of mediator release and action.

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Picumast dihydrochloride (PDH), (3,4-dimethyl-7-[4-chlorobenzyl) piperazine-1-yl]propoxycoumarin dihydrochloride) is a prophylactically active anti-allergic compound which combines inhibition of mediator release and action. The activity profile of PDH differs clearly from that of known prophylactic anti-allergic drugs such as DSCG and ketotifen. Other inhibitory actions of PDH in addition to its H1-antagonism (and that of its metabolites M2 and M1) may be the cause of the suppression of immediate and late phase allergic reactions in animals as well as allergic rhinitis and bronchial responsiveness and symptom scores in asthmatic patients.

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A double-masked study was performed to investigate a possible side effect of the antiallergic substance Picumast dihydrochloride on lens transparency. 372 patients with Picumast dihydrochloride- or Ketotifen-treatment regularly underwent ophthalmologic examinations and Scheimpflug photography of the anterior eye segment. Results of slitlamp examinations as well as microdensitometric analyzes of the film negatives after one year treatment did not reveal any evidence that Picumast dihydrochloride compromised lens transparency in humans.

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October 1989

Department of Product Development, Boehringer Mannheim GmbH, Fed Rep. of Germany.

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The efficacy and tolerability of picumast dihydrochloride (3,4-dimethyl-7-[4-(4-chlorobenzyl)piperazine-1-yl]propoxycoumarin dihydrochloride) (2 mg twice daily orally) in comparison with ketotifen (1 mg twice daily orally) was investigated in 400 patients with bronchial asthma (picumast dihydrochloride n = 202, ketotifen n = 198) in a double-blind, controlled, parallel group study. Assessment of therapeutic and preventative efficacy was by means of symptom scores, quantitative measurements (accumulatory threshold dose) of the bronchial hyperreactivity by means of inhalatory acetylcholine provocation, measurements of peak expiratory flow, vital capacity (VC) and 1-s capacity (FEV1) as well as global assessment of efficacy by the doctor and patient. Tolerability was assessed by recording side effects and global assessment of tolerance on a rank scale at the end of the treatment as well as by means of clinico-chemical parameters.

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Efficacy and tolerability of picumast dihydrochloride in comparison with placebo in asthmatic patients.

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Department of Product Development, Boehringer Mannheim GmbH, Fed. Rep. of Germany.

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