Bronchodilator efficacy of tiotropium in patients with mild to moderate COPD.
OBJECTIVE
Evaluation of tiotropium efficacy in patients with mild chronic obstructive pulmonary disease (COPD) defined by the 2003 Swedish Society of Respiratory Medicine guidelines (post-bronchodilator FEV1/FVC <70%; FEV1 >60% predicted).


METHODS
In this 12-week, randomised, double-blind, placebo-controlled study of tiotropium 18 mcg once daily versus placebo, respiratory function was assessed on Days 1, 15 and 85 (baseline: pre-dose Day 1).


RESULTS
Mean+/-SD baseline FEV1 (% predicted) was 73.4+/-12.5 (tiotropium, n=107; placebo, n=117). Tiotropium significantly improved change from baseline in area under the curve from pre-dose to 2 hours post-dose (AUC0-2 h) FEV1 versus placebo, by 166+/-26 mL (mean+/-SE) at study end (p<0.0001). With tiotropium, there were significant increases in the change in AUC0-2 h FVC versus baseline, and trough FEV1 and FVC, versus placebo, on all test days (p<0.01). Adverse event rates were similar.


CONCLUSIONS
Compared with placebo, tiotropium improved lung function in patients with mild COPD.
Nyby Healthcare Centre and Department of Public Health and Caring Sciences, Uppsala University, Uppsala, Sweden. gunnar.johansson@pubcare.uu.se
Gunnar
G
Johansson
Anne
A
Lindberg
Kerstin
K
Romberg
Lars
L
Nordström
Fronke
F
Gerken
Annika
A
Roquet
D001993:Bronchodilator Agents / Q000627:therapeutic use*; D004311:Double-Blind Method; D004417:Dyspnea / Q000188:drug therapy / Q000209:etiology; D005260:Female; D005541:Forced Expiratory Volume / Q000187:drug effects; D006801:Humans; D008297:Male; D008875:Middle Aged; D029424:Pulmonary Disease, Chronic Obstructive / Q000188:drug therapy*; D011788:Quality of Life; D012602:Scopolamine Derivatives / Q000627:therapeutic use*; D012720:Severity of Illness Index; D013147:Spirometry; D000069447:Tiotropium Bromide; D014797:Vital Capacity / Q000187:drug effects
D001993:Bronchodilator Agents; D012602:Scopolamine Derivatives; D000069447:Tiotropium Bromide