[Delayed-release salbutamol, a new beta-mimetic with prolonged action. Results of a comparative study against...

Salbutamol controlled-release (CR), a new salbutamol formulation, was compared in asthmatic patients to another long-acting bronchodilator, theophylline L.A., in a randomized (2 salbutamol, 1 theophylline), multicentre, parallel-group study. Among the 83 patients who met the inclusion criteria (mean age 41 years), 55 received salbutamol CR and 28 received theophylline L.A. during 6 weeks. At the end of the study, there was a significant difference (p less than 0.05) in favour of salbutamol CR for FEV1 (2.53 l versus 2.13 l) and VC (4.23 l versus 3.50 l). FEF25-75 and PEF were higher with salbutamol CR, respectively 2.06 l sec-1 versus 1.86 l sec-1 and 6.03 l sec-1 versus 5.03 l sec-1. PEFR, measured by the patient, improved more with salbutamol CR than with theophylline L.A., with a significant difference as from the third week. There was a significant difference at the end of the study too, both morning (408 l min-1 versus 350.1 l min-1, p less than 10(-3] and evening (408.9 l min-1 versus 353 l min-1, p less than 10(-3]. Salbutamol CR and theophylline L.A. were considered as well tolerated, respectively by 95.5% of the patients in the salbutamol group and 92.3% of the patients in the theophylline group. There were equal numbers of minor and usual adverse events in the two groups. Salbutamol CR showed a better efficacy in airways obstruction without systemic safety problems. It is therefore an excellent treatment for patients requiring bronchodilator maintenance therapy.