title: A controlled trial of an oral bronchodilator preparation ('Franol') in asthma.
abstract: In view of the lack of published data on the oral bronchodilator preparation 'Franol' (120 mg theophylline, 11 mg ephedrine hydrochloride and 8 mg phenobarbitone per tablet) a double-blind study was carried out to compare the effects on lung function of a single dose of 2 'Franol' tablets, 1 'Franol' plus 1 placebo tablet, or 2 placebo tablets over a period of 8 hours in 30 asthmatic patients with reversible airways resistance (mean FEV1 1.31 l increasing to 1.71 l after 200 micrograms salbutamol inhalation). 'Franol' produced dose-dependent bronchodilation. Two tablets caused significant bronchodilation from 90 minutes to 8 hours (peak change from baseline at 2.5 hours: FEV1 20.8%, PEFR 22.3%). One tablet of 'Franol' produced significant bronchodilation only between 60 minutes and 3 hours (change from baseline at 2.5 hours: FEV1 7.5%, PEFR 7.9%). There was no change in lung function with placebo (change from baseline at 2.5 hours: FEV1 5.4%, PEFR 5.9%). Median serum theophylline levels at 2.5 hours were 6.38 micrograms/ml for 2 tablets and 3.18 micrograms/ml for 1 tablet. Median peak phenobarbitone levels were 0.5 micrograms/ml. There were no clinically relevant changes in pulse rate and blood pressure during the study and no adverse events were reported.
mesh_terms: D000284:Administration, Oral; D000293:Adolescent; D000328:Adult; D000368:Aged; D001249:Asthma / Q000188:drug therapy*; D001993:Bronchodilator Agents / Q000627:therapeutic use*; D002986:Clinical Trials as Topic; D004338:Drug Combinations / Q000627:therapeutic use; D004809:Ephedrine / Q000627:therapeutic use*; D005029:Ethylenediamines / Q000627:therapeutic use*; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D010634:Phenobarbital / Q000627:therapeutic use*; D013806:Theophylline / Q000627:therapeutic use*
chemical_list: D001993:Bronchodilator Agents; D004338:Drug Combinations; D005029:Ethylenediamines; C001258:franol; D013806:Theophylline; D004809:Ephedrine; D010634:Phenobarbital