ACEBROPHYLLINE AND THEOPHYLLINE IN THE TREATMENT OF BRONCHIAL-ASTHMA - AN OPEN COMPARATIVE, RANDOMIZED STUDY

Therapeutic activity and safety of acebrophylline syrup (100 mg b.i.d. ) and theophylline elixir(158 mg t.i.d.), each given for 10 days, were compared in 30 adult patients (20 males, 10 females) with chronic obs tructive lung disease and asthma (mean age 47.9 +/- 19.4 years). Patie nts were randomly allocated to treatment. To evaluate efficacy, sympto ms and signs, including cough, dyspnoea, cyanosis, chest rales, diffic ult expectoration, and the qualitative-quantitative characteristics of sputum were assessed every day throughout the study. Respiratory func tion parameters, including forced expiratory volume per second (FEV,) and vital capacity (VC), were determined and Tiffeneau's index (TI) wa s calculated before and after treatment. Adverse events were recorded and routine laboratory tests were performed before and after treatment to evaluate safety. The results showed improvement in respiratory fun ction tests after both acebrophylline and theophylline, without signif icant differences between drugs. Improvement of symptoms and signs occ urred earlier and was more marked in the acebrophylline group than in the group receiving reference drug. These results are consistent with previous findings that acebrophylline possesses both muco-regulating a nd bronchodilator effects in comparison with theophylline which has on ly bronchodilator effects. Both drugs showed good tolerability; only t wo patients receiving theophylline and one assigned to acebrophylline complained of transient and mild gastric disorders which did not requi re discontinuation of treatment or specific therapy.