2002 | R. Casaburi*, D.A. Mahler#, P.W. Jones*, A. Wanner†, G. San Pedro§, R.L. ZuWallack†, S.S. Menjoge**, C.W. Serby**, T. Witek Jr**
This study evaluates the long-term safety and efficacy of tiotropium, a once-daily anticholinergic bronchodilator, in patients with chronic obstructive pulmonary disease (COPD). Two identical randomized double-blind placebo-controlled trials were conducted, enrolling 921 patients with stable COPD. Patients inhaled tiotropium 18 μg or placebo once daily for 1 year. The primary outcome was trough FEV1, with additional assessments of dyspnoea, health status, and adverse events. Tiotropium significantly improved FEV1 and peak expiratory flow rate (PEFR) compared to placebo, with sustained bronchodilation over the 12-month period. Patients on tiotropium experienced less dyspnoea, better health status, fewer exacerbations, and reduced hospitalizations. Adverse events were comparable between groups, except for dry mouth, which was more common in the tiotropium group. The study concludes that tiotropium is an effective, once-daily bronchodilator that reduces dyspnoea, exacerbation frequency, and improves health status, making it a valuable addition to COPD therapy.This study evaluates the long-term safety and efficacy of tiotropium, a once-daily anticholinergic bronchodilator, in patients with chronic obstructive pulmonary disease (COPD). Two identical randomized double-blind placebo-controlled trials were conducted, enrolling 921 patients with stable COPD. Patients inhaled tiotropium 18 μg or placebo once daily for 1 year. The primary outcome was trough FEV1, with additional assessments of dyspnoea, health status, and adverse events. Tiotropium significantly improved FEV1 and peak expiratory flow rate (PEFR) compared to placebo, with sustained bronchodilation over the 12-month period. Patients on tiotropium experienced less dyspnoea, better health status, fewer exacerbations, and reduced hospitalizations. Adverse events were comparable between groups, except for dry mouth, which was more common in the tiotropium group. The study concludes that tiotropium is an effective, once-daily bronchodilator that reduces dyspnoea, exacerbation frequency, and improves health status, making it a valuable addition to COPD therapy.