Acceptability, safety and efficacy of picumast dihydrochloride on long-term use in patients with perennial bronchial asthma. 1989

D Boerner, and K Metz, and R Eberhardt
Department of Product Development, Boehringer Mannheim GmbH, Fed Rep. of Germany.

104 adult patients with predominantly extrinsic perennial asthma who were maintained on bronchodilator or glucocorticoid therapy, were entered into a one-year open study designed to evaluate the efficacy, safety and acceptability of picumast dihydrochloride (3,4-dimethyl-7-[4-(4-chlorobenzyl)piperazine-1-yl]propoxycoumarin dihydrochloride) (2 mg twice daily). 74 patients completed the 12-month treatment period and a further 18 (total 92) were followed up for at least 2 months. Adverse drug reactions were reported in 14 patients and 5 of them were withdrawn from the trial for only non serious reactions. 12 patients were excluded from the analysis of efficacy because they dropped out early and no sufficient data were available for a judgement. Although this was an open study, analysis of diary card measurements and clinical assessments indicate that picumast dihydrochloride could represent a new and effective prophylactic therapy in the long-term management of bronchial asthma. Picumast dihydrochloride improved forced expiratory volume in 1 s (FEV1), peak flow and subjective asthmatic symptoms in 51%, 64% and 70% of the patients, respectively. 92% of those who participated in this study were willing to take the study drug again.

UI MeSH Term Description Entries
D008297 Male Males
D003374 Coumarins Synthetic or naturally occurring substances related to coumarin, the delta-lactone of coumarinic acid. 1,2-Benzopyrone Derivatives,1,2-Benzopyrones,Coumarin Derivative,Coumarine,1,2-Benzo-Pyrones,Benzopyran-2-ones,Coumarin Derivatives,Coumarines,1,2 Benzo Pyrones,1,2 Benzopyrone Derivatives,1,2 Benzopyrones,Benzopyran 2 ones,Derivative, Coumarin,Derivatives, 1,2-Benzopyrone,Derivatives, Coumarin
D005260 Female Females
D005541 Forced Expiratory Volume Measure of the maximum amount of air that can be expelled in a given number of seconds during a FORCED VITAL CAPACITY determination . It is usually given as FEV followed by a subscript indicating the number of seconds over which the measurement is made, although it is sometimes given as a percentage of forced vital capacity. Forced Vital Capacity, Timed,Timed Vital Capacity,Vital Capacity, Timed,FEVt,Capacities, Timed Vital,Capacity, Timed Vital,Expiratory Volume, Forced,Expiratory Volumes, Forced,Forced Expiratory Volumes,Timed Vital Capacities,Vital Capacities, Timed,Volume, Forced Expiratory,Volumes, Forced Expiratory
D006634 Histamine H1 Antagonists Drugs that selectively bind to but do not activate histamine H1 receptors, thereby blocking the actions of endogenous histamine. Included here are the classical antihistaminics that antagonize or prevent the action of histamine mainly in immediate hypersensitivity. They act in the bronchi, capillaries, and some other smooth muscles, and are used to prevent or allay motion sickness, seasonal rhinitis, and allergic dermatitis and to induce somnolence. The effects of blocking central nervous system H1 receptors are not as well understood. Antihistamines, Classical,Antihistaminics, Classical,Antihistaminics, H1,Histamine H1 Antagonist,Histamine H1 Receptor Antagonist,Histamine H1 Receptor Antagonists,Histamine H1 Receptor Blockaders,Antagonists, Histamine H1,Antagonists, Histamine H1 Receptor,Antihistamines, Sedating,Blockaders, Histamine H1 Receptor,First Generation H1 Antagonists,H1 Receptor Blockaders,Histamine H1 Blockers,Receptor Blockaders, H1,Antagonist, Histamine H1,Classical Antihistamines,Classical Antihistaminics,H1 Antagonist, Histamine,H1 Antagonists, Histamine,H1 Antihistaminics,Sedating Antihistamines
D006801 Humans Members of the species Homo sapiens. Homo sapiens,Man (Taxonomy),Human,Man, Modern,Modern Man
D000328 Adult A person having attained full growth or maturity. Adults are of 19 through 44 years of age. For a person between 19 and 24 years of age, YOUNG ADULT is available. Adults
D001249 Asthma A form of bronchial disorder with three distinct components: airway hyper-responsiveness (RESPIRATORY HYPERSENSITIVITY), airway INFLAMMATION, and intermittent AIRWAY OBSTRUCTION. It is characterized by spasmodic contraction of airway smooth muscle, WHEEZING, and dyspnea (DYSPNEA, PAROXYSMAL). Asthma, Bronchial,Bronchial Asthma,Asthmas
D014797 Vital Capacity The volume of air that is exhaled by a maximal expiration following a maximal inspiration. Forced Vital Capacity,Capacities, Forced Vital,Capacities, Vital,Capacity, Forced Vital,Capacity, Vital,Forced Vital Capacities,Vital Capacities,Vital Capacities, Forced,Vital Capacity, Forced

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