Comparison of intravenously administered doxofylline and placebo for the treatment of severe acute airways obstruction.

This double-blind, randomized, placebo-controlled study investigated the therapeutic effects of a single dose of doxofylline, a methylxanthine derivative, in 10 patients aged 26-79 years. All patients had acute exacerbation of chronic obstructive airways disease partially reversible with salbutamol inhaler. Doxofylline was administered intravenously at a dose of 200 mg over 15 min on two different occasions separated by at least 24 h. Doxofylline increased forced expiratory volume in the first second of expiration compared with baseline as follows: +20% after 2 h (P less than 0.01); +31% after 4 h (P less than 0.01); and +13% after 6 h (NS). Changes produced by placebo at these times were -4.4%, -14% and -5% (all NS). The average differences between the groups were significant at all observation times. At the end of the observation period eight out of 10 patients given doxofylline and one out of 10 patients given placebo had improved clinically according to the patients' own opinion. Clinical tolerability of doxofylline proved to be good since no signs of local or general side-effects were observed in any of the patients treated.

RCT Entities:   Population Interventions Outcomes