A long-term clinical trial on the efficacy and safety profile of doxofylline in Asthma: The LESDA study

Publication date: Available online 26 December 2019Source: Pulmonary Pharmacology & TherapeuticsAuthor(s): Luigino Calzetta, Maria Gabriella Matera, Marc F. Goldstein, William R. Fairweather, William W. Howard, Mario Cazzola, Paola RoglianiAbstractDoxofylline, an oral methylxanthine with bronchodilator and anti-inflammatory activities, offers a promising alternative to theophylline due to its superior efficacy/safety profile. No long-term studies on the efficacy and safety on doxofylline are currently available in asthma. The aim of the Long-term clinical trial on the Efficacy and Safety profile of Doxofylline in Asthma (LESDA) study was to investigate the safety and efficacy profile of doxofylline administered for one year in asthmatic patients. LESDA was a multicenter, open-label, Phase III, clinical trial in which adult asthmatic patients received the same treatment (oral doxofylline 400 mg t.i.d.) for one year. 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.Three-hundred nine patients were screened and allocated in the study. Doxofylline significantly improved the change from baseline in forced expiratory volume in 1 s (FEV1) (+16.90 ± 1.81%, P < 0.001 vs. baseline). Doxofylline also significantly improved the rate of asthma events (events/day: 0.57 ± 0.18) and t...
Source: Pulmonary Pharmacology and Therapeutics - Category: Respiratory Medicine Source Type: research