A total of 30 patients (27 males and 3 females) with a mean age of 62.6 +/- 3.9 years, suffering from chronic obstructive pulmonary disease were recruited into this open study to evaluate the clinical efficacy and the safety of a short course of treatment with 100 mg acebrophylline, twice daily for 14 days. To assess the effectiveness of the drug, symptoms and signs, such as cough intensity and frequency, auscultatory pattern, dyspnoea, cyanosis, difficulty of expectoration, sputum quantity, appearance and density, were evaluated at baseline and after 1, 3, 5, 7, 10 and 14 days of therapy. In addition the rheological properties of the bronchial mucus (viscosity and spinnability) were measured and respiratory function tests were performed before and after treatment. There was a progressive improvement of all evaluated symptoms and signs, resulting in improvement of the auscultatory pattern, as well as dyspnoea. This was accompanied by improvement or normalization of the respiratory function indices, which showed statistically significant differences (P < 0.01) between the baseline and the endpoint values, apart from total lung capacity. Blood-gas analysis demonstrated a significant increase of PaO2 and a significant decrease of PaCO2 values at the end of the treatment period (both P < 0.01). In general, acebrophylline was well tolerated. No clinically relevant or significant changes in any of the routine laboratory parameters were found on comparing the values obtained before and after treatment, Only three patients complained of epigastric pain, but this was not so severe or long-lasting as to require the discontinuation of the treatment.
