A multicenter randomized double-blind placebo-controlled trial published in the New England Journal of Medicine demonstrated that the use of tiotropium improved lung function and quality of life in patients with mild or moderate chronic obstructive pulmonary disease (COPD).
This study (Tie-COPD; ClinicalTrials.gov identifier: NCT01455129), which was conducted in China, randomly assigned a group of 841 patients with COPD classified according to the Global Initiative for Chronic Obstructive Lung Disease (GOLD) as stage 1 (mild) or stage 2 (moderate) severity to receive once-daily inhaled tiotropium 18 μg (n=419) or placebo (n=422) for 2 years.
The primary end point was the between-group difference in change from baseline to 24 months in FEV1 before bronchodilator use. Secondary end points included between-group differences in the following: change from baseline to 24 months in FEV1 after bronchodilator use and in annual decline in FEV1 before and after bronchodilator use from day 30 to month 24.
Of the 841 randomized patients, a total of 388 in the tiotropium group and 383 in the placebo group were included in the full analysis. Findings from the study showed that FEV1 in patients treated with tiotropium was higher than in patients given placebo throughout the duration of the trial (range of mean differences, 127-169 mL before bronchodilator use vs 71-133 mL after bronchodilator use; P <.001 for all comparisons).
No significant improvement was observed in mean annual decline in FEV1 before bronchodilator use, with a decline of 38 mL per year in the tiotropium group vs 53 mL per year in the placebo group (95% CI, −1 to 31 mL; P =.06). In comparison, annual decline in FEV1 after bronchodilator use was significantly lower in the tiotropium group than in the placebo group (29 mL per year vs 51 mL per year, respectively; 95% CI, 6-37 mL; P =.006).
Treatment with tiotropium was associated with a higher FEV1 vs placebo at 24 months. The use of tiotropium stalled the annual decline in FEV1 after bronchodilator use in patients with GOLD stage 1 or 2 COPD. Further research is warranted to examine whether early intervention with tiotropium alters the long-term course of COPD.
Zhou Y, Zhong NS, Li X, et al. Tiotropium in early-stage chronic obstructive pulmonary disease. N Engl J Med. 2017;377(10):923-935.