Pharmacokinetics and clinical response to single- and multiple-dose sustained-release theophylline compounds in perennial bronchial asthma.

Nine adult subjects with perennial bronchial asthma participated in a single-blind, cross-over, placebo-controlled study to evaluate and compare the effectiveness of a 24-hour sustained-release theophylline formulation, Uniphyl, with that of a twice-daily compound, Theo-Dur. The subjects took each drug for two weeks and monitored peak expiratory flow and recorded their symptoms in a diary three times daily. At the end of each experimental period, they were hospitalized for 24 hours for determination of the pharmacokinetics of the compound they were taking and the relationship between fluctuations in theophylline blood levels and changes in pulmonary mechanics. Both drugs were highly effective, and no significant differences between formulations were found in any aspects of the study. The results demonstrate that a single daily dose of Uniphyl is an efficacious form of therapy for controlling perennial asthma in adults.

RCT Entities:   Population Interventions Outcomes