A controlled trial of an oral bronchodilator preparation ('Franol') in asthma.
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| 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.
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| Authors | S Owen, P Stone, L Campbell, S Webster, A A Woodstock |
| Journal | Pharmatherapeutica (Pharmatherapeutica) Vol. 5 Issue 4 Pg. 240-5 ( 1988) ISSN: 0308-051X [Print] England |
| PMID | 3051044 (Publication Type: Clinical Trial, Controlled Clinical Trial, Journal Article, Randomized Controlled Trial) |
| Chemical References |
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