Scimago Lab
powered by Scopus
call: +1.631.470.9640
Mon-Fri 10 am - 2 pm EST


Medical Science Monitor Basic Research


eISSN: 1643-3750

Get your full text copy in PDF

Efficacy and safety of doxofylline compared to theophylline in chronic reversible asthma - a double-blind randomized placebo-controlled multicentre clinical trial

Marc F Goldstein, Paul Chervinsky

Med Sci Monit 2002; 8(4): CR297-304

ID: 420864

BACKGROUND: Experimental studies have shown that doxofylline is endowedwith a remarkable bronchodilator activity with less extra-respiratory effects than theophylline. Thistrial was designed to compare the efficacy and safety of doxofylline, theophylline, and placebo in patientswith chronic reversible bronchial asthma. MATERIAL/METHODS: Three hundred forty-six patients were randomlyassigned to a 12-week oral treatment with either doxofylline 400 mg t.i.d. (high dose), doxofylline 200mg t.i.d. (low dose), theophylline 250 mg t.i.d. (active control) or placebo. Pulmonary function tests(PFTs) were performed biweekly. Patients kept records of peak flow meter (PFM) measurements, asthma attackrate and beta-2-agonist use (albuterol). RESULTS: Changes in FEV1 2 hours after the administration oftreatments versus baseline exhibited statistically significant differences between doxofylline 400 mgt.i.d. and placebo and between theophylline and placebo. Similar differences were monitored on the othervariables (FVC, PFER, FEF(25-75%). Asthma attack rate and use of albuterol decreased remarkably withdoxofylline 400 mg t.i.d. and theophylline. There were few statistically significant differences betweendoxofylline 200 mg t.i.d. and placebo. Significantly more patients had to interrupt treatment becauseof adverse events under theophylline than under doxofylline 400 mg t.i.d. (p=0.001). With doxofylline400 mg t.i.d., the number of patients treated to spare one drop-out due to theophylline was 5. CONCLUSIONS:This study provides evidence that doxofylline 400 mg t.i.d. is an effective treatment for relieving airwayobstruction and displays a better safety profile with respect to theophylline 250 mg t.i.d. with a favorablerisk-to-benefit ratio.

This paper has been published under Creative Common Attribution-NonCommercial-NoDerivatives 4.0 International (CC BY-NC-ND 4.0) allowing to download articles and share them with others as long as they credit the authors and the publisher, but without permission to change them in any way or use them commercially.
I agree