Impact of doxofylline compared to theophylline in asthma: A pooled analysis of functional and clinical outcomes from two multicentre, double-blind, randomised studies (DOROTHEO 1 and DOROTHEO 2)

Publication date: Available online 13 September 2018Source: Pulmonary Pharmacology & TherapeuticsAuthor(s): Luigino Calzetta, Nicola A. Hanania, Frank L. Dini, Marc F. Goldstein, William R. Fairweather, William W. Howard, Mario CazzolaAbstractThis pooled analysis of double-blind, randomized, placebo-controlled trials aimed to investigate the Impact of DOxofylline compaRed tO THEOphylline (DOROTHEO 1 and DOROTHEO 2 studies) on functional and clinical outcomes in asthma. Patients with asthma ≥16 years of age with (forced expiratory volume in 1 s [FEV1] ≥50% and <80% and with ≥15% post-bronchodilator increase in FEV1) were randomized in a 1:1:1:1 ratio in DOROTHEO 1 to receive doxofylline 200 mg, doxofylline 400 mg, theophylline 250 mg, or placebo; in DOROTHEO 2 patients were randomized in a 1:1:1 ratio to receive doxofylline 400 mg, theophylline 250 mg, or placebo. All double-blind treatments were taken orally with immediate release formulations and three times daily. Data evaluating the effect of doxofylline 400 mg, theophylline 250 mg and placebo on FEV1, asthma events rate, use of salbutamol as rescue medication and adverse events (AEs) were pooled from both studies. The pooled-analysis of 483 patients demonstrated that both doxofylline 400 mg and theophylline 250 mg significantly increased FEV1, reduced the rate of asthma events and use of salbutamol to relieve asthma symptoms compared to placebo (p < 0.01). No significant differences w...
Source: Pulmonary Pharmacology and Therapeutics - Category: Respiratory Medicine Source Type: research