Bronchodilators are the mainstay in symptomatic management of stable chronic obstructive pulmonary disease (COPD). At exacerbation, bronchoconstriction may get worse and thus it is logical to increase the dose and/or frequency of administration of bronchodilator agents. This study aimed to evaluate whether erdosteine used concomitantly with levofloxacin in patients with acute exacerbation of COPD with purulent sputum could reduce the frequency of bronchodilator inhalation during exacerbation episodes. This study is a randomised doubleblind placebo-controlled clinical study with the primary endpoint was the mean frequency of bronchodilator consumption per-day evaluated on day 8. Secondary endpoints were improvement of clinical symptoms and the Global Efficacy Index. Group 1 were treated with erdosteine and levofloxacin, whilst group 2 with placebo and levofloxacin. Erdosteine or its matching placebo was administered 2x 300 mg/day for seven days; while levofloxacin, 500 mg o.d. Ninety patients aged 45-80 years were enrolled. Erdosteine group needed significantly less bronchodilator than those in placebo group, p<0.001. At the end of study, a higher rate of clinical improvement was observed in erdosteine group (61.9%) than placebo group (46.7%) with a slightly greater improvement in sputum purulence and sputum viscosity in erdosteine group as well. No statistical significance found in such secondary endpoints. Majority of adverse events were mild and comparable between groups. Erdosteine in addition to levofloxacin in patients with acute exacerbation of COPD with purulent sputum provided a significant reduction in patients’ need for bronchodilators and was well tolerated.
|Journal||Journal of the Indonesian Medical Association|
|Publication status||Published - Oct 2007|