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Therapeutic equivalence between bambuterol, 10 mg once daily, and terbutaline controlled release, 5 mg twice daily, in mild to moderate asthma. 1993

A M Fugleholm, and T B Ibsen, and L Laxmyr, and U G Svendsen
Dept of Pulmonary Medicine/Allergology Y, Gentofte County Hospital, University of Copenhagen, Hellerup, Denmark.

Bambuterol is the first long-acting oral beta 2-agonist with a 24 h effective duration. In order to investigate the possibility of replacing established treatment modalities with bambuterol once daily, we wanted to compare the bronchodilating and tremorogenic effects of bambuterol, 10 mg once daily, and terbutaline, 5 mg controlled-release (CR) tablets twice daily. The study was of a double-blind, double-dummy, randomized, cross-over design and involved two, two week treatment periods, separated by a one week wash-out period. Peak expiratory flow (PEF) recorded in patients' diaries was the primary efficacy variable. Seventy adult, asthmatic out-patients with mild to moderate asthma were included (forced expiratory volume in one second (FEV1) > or = 50% predicted). After treatment with bambuterol, mean morning and evening PEF (SD) were 347 (122) and 365 (121) l.min-1, respectively and 346 (121) and 365 (122) l.min-1, respectively, after treatment with terbutaline. FEV1 (SD) was 2.21 (0.91) l and 2.27 (0.93) l after bambuterol and terbutaline treatments, respectively. Tremor scores tended to be lower during treatment with bambuterol, although not significantly so. Tremor scores were low, in general. In conclusion, no difference in the bronchodilating effect was demonstrated between bambuterol, 10 mg once daily, and controlled release terbutaline, 5 mg twice daily. A tendency towards less tremor was seen with bambuterol.

UI MeSH Term Description Entries
D008297 Male Males
D010366 Peak Expiratory Flow Rate Measurement of the maximum rate of airflow attained during a FORCED VITAL CAPACITY determination. Common abbreviations are PEFR and PFR. Expiratory Peak Flow Rate,Flow Rate, Peak Expiratory,PEFR
D001993 Bronchodilator Agents Agents that cause an increase in the expansion of a bronchus or bronchial tubes. Bronchial-Dilating Agents,Bronchodilator,Bronchodilator Agent,Broncholytic Agent,Bronchodilator Effect,Bronchodilator Effects,Bronchodilators,Broncholytic Agents,Broncholytic Effect,Broncholytic Effects,Agent, Bronchodilator,Agent, Broncholytic,Agents, Bronchial-Dilating,Agents, Bronchodilator,Agents, Broncholytic,Bronchial Dilating Agents,Effect, Bronchodilator,Effect, Broncholytic,Effects, Bronchodilator,Effects, Broncholytic
D003692 Delayed-Action Preparations Dosage forms of a drug that act over a period of time by controlled-release processes or technology. Controlled Release Formulation,Controlled-Release Formulation,Controlled-Release Preparation,Delayed-Action Preparation,Depot Preparation,Depot Preparations,Extended Release Formulation,Extended Release Preparation,Prolonged-Action Preparation,Prolonged-Action Preparations,Sustained Release Formulation,Sustained-Release Preparation,Sustained-Release Preparations,Timed-Release Preparation,Timed-Release Preparations,Controlled-Release Formulations,Controlled-Release Preparations,Extended Release Formulations,Extended Release Preparations,Slow Release Formulation,Sustained Release Formulations,Controlled Release Formulations,Controlled Release Preparation,Controlled Release Preparations,Delayed Action Preparation,Delayed Action Preparations,Formulation, Controlled Release,Formulations, Controlled Release,Prolonged Action Preparation,Release Formulation, Controlled,Release Formulations, Controlled,Sustained Release Preparation,Timed Release Preparation,Timed Release Preparations
D004311 Double-Blind Method A method of studying a drug or procedure in which both the subjects and investigators are kept unaware of who is actually getting which specific treatment. Double-Masked Study,Double-Blind Study,Double-Masked Method,Double Blind Method,Double Blind Study,Double Masked Method,Double Masked Study,Double-Blind Methods,Double-Blind Studies,Double-Masked Methods,Double-Masked Studies,Method, Double-Blind,Method, Double-Masked,Methods, Double-Blind,Methods, Double-Masked,Studies, Double-Blind,Studies, Double-Masked,Study, Double-Blind,Study, Double-Masked
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
D006801 Humans Members of the species Homo sapiens. Homo sapiens,Man (Taxonomy),Human,Man, Modern,Modern Man
D000293 Adolescent A person 13 to 18 years of age. Adolescence,Youth,Adolescents,Adolescents, Female,Adolescents, Male,Teenagers,Teens,Adolescent, Female,Adolescent, Male,Female Adolescent,Female Adolescents,Male Adolescent,Male Adolescents,Teen,Teenager,Youths
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

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