Study objective: To compare the bronchodilator efficacy
and safety of tiotropium and placebo.
3-month, randomized, double-blind, placebo-controlled, multicenter
Four hundred seventy patients with stable COPD (mean
FEV1 = 38.6% predicted).
Tiotropium 18 μg (N = 279) or placebo (N = 191) given once daily
via a lactose-based dry-powder inhaler device.
and results: Spirometry was evaluated on days 1, 8, 50, and 92.
Data were expressed as the mean trough (ie, before
morning dose; 23 to 24 h after previous dose) and average response
observed in the 3 h after the dose was received. Tiotropium
produced significant improvement in trough FEV1 and FVC,
averaging 12% greater than baseline on day 8; these improvements were
maintained on days 50 and 92. The average postdose FEV1 was
16% greater than baseline on day 1 and 20% greater than baseline on
day 92; FVC was 17% greater than baseline on day 1 and 19% greater
than baseline on day 92. Tiotropium was significantly more effective
than placebo in both trough and average FEV1 and FVC
response (p < 0.001). These spirometric effects were corroborated by
significant improvements in daily morning and evening peak expiratory
flow rate, as well as a reduction in “as-needed” albuterol use.
Symptoms of wheezing and shortness of breath were significantly less in
patients receiving tiotropium, and the physician global assessment
noted overall improvements with those treated with tiotropium relative
to placebo. The most common reported adverse event after tiotropium was
dry mouth (9.3% vs 1.6% relative to placebo; p < 0.05).
Conclusions: These data demonstrate that tiotropium is a
safe and effective once-daily anticholinergic bronchodilator and should
prove useful as first-line maintenance therapy in