Efficacy, safety and cost effectiveness of oral Doxofylline and Theophylline for mild to moderate persistent bronchial asthma: A randomized prospective open labeled comparative study.

Abstract

AIM : To compare the efficacy, safety and cost effectiveness of oral Doxofylline and Theophylline for mild to moderate persistent bronchial asthma patients. MATERIALS AND METHODS: A Randomized prospective, open labeled comparative study of 1 year (Jul 2014-Jun 2015) duration was conducted in 186 patients who were attending the thoracic medicine outpatient department of Chengalpattu Medical College satisfying the inclusion and exclusion criteria after obtaining ethical clearance. METHODOLOGY: The study subjects were randomly allocated into two groups. Group 1 patients were treated with Doxofylline 400mg once daily and group 2 patients were treated with Theophylline twice daily. Demographic data, history, clinical examination and details of drug prescription by the treating physician were recorded in the study proforma. Relevant lab investigations were done at the beginning and at the end of the study. The patients were followed up for 12 weeks. The schedule of patient visit is as follows Visit 1 for initial or baseline assessment and follow-up at 4, 8 & 12 weeks. STATISTICAL ANALYSIS: The data collected were analyzed using Student t test (two tailed, independent) to find the significance of study parameters on continuous scale between two groups. Chi-square/ Fisher Exact test was used to find the significance of study parameters on categorical scale between two or more groups. RESULT: Doxofylline was better than deriphylline in subjective parameters of asthma control test questionnaire and subjective rating of asthma control. Doxofylline had equal efficacy as that of deriphylline in spirometric parameters (p ≤ 0.001). Doxofylline was significantly safe compared to deriphylline as inferred from lesser incidence of adverse drug reactions. Adverse reactions are encountered in 10% of doxofylline and 22% of deriphylline group. Deriphylline was the cheaper and cost effective methylxanthene for the treatment of bronchial asthma in developing countries at population level. Doxofylline even though costlier had better safety profile with less adverse reactions compared to deriphylline. It can be used as an individual based approach in asthma management. CONCLUSION: Doxofylline is a newer methylxanthine with few adverse effects and equal efficacy as compared with deriphylline. It is a better alternative in the management of bronchial asthma