A long-term (2 years) efficacy and safety study of doxofylline in the treatment of asthma

Abstract

Background: Recent RCTs (DOROTHEO 1 and DOROTHEO 2) demonstrated that doxofylline, an oral methylxanthine with bronchodilator and anti-inflammatory activities, offers a promising alternative to theophylline with a superior efficacy/safety profile in the management of patients with asthma. However, to date long-term studies on the efficacy and safety doxofylline are still missing in asthma. Aims and Objectives: To investigate the long-term safety and efficacy of doxofylline in the treatment of subjects with asthma. Methods: In an open-label study, adult asthmatic patients received the same treatment (oral doxofylline 400 mg t.i.d) for up to 2 years. Efficacy was assessed through periodic pulmonary function tests and by having the subjects keep monthly records of asthma events rates and use of salbutamol as rescue medication. The rate of adverse events (AEs) was recorded during the study. Results: 309 patients were screened and 227 subjects were enrolled. Doxofylline significantly (P Conclusions: This study suggests that doxofylline is effective and well tolerated when administered chronically in asthmatic patients.