COPD · Does any drug slow COPD progression?
A 4-year trial of tiotropium in chronic obstructive pulmonary disease
| Design | Randomised, double-blind, placebo-controlled trial over 4 years |
|---|---|
| Treatment | Tiotropium 18 microg once daily, added to all other respiratory medications except anticholinergics |
| Control | Placebo, with all other respiratory medications permitted |
| Population | 5993 patients with COPD, mean age 65±8, mean post-bronchodilator FEV1 1.32±0.44 L (48% predicted) |
| Follow-up | 4 years |
| Primary endpoint | Rate of decline in FEV1 before and after bronchodilation |
| Result | Absolute FEV1 improvements with tiotropium were sustained throughout — 87 to 103 mL before and 47 to 65 mL after bronchodilation (p<0.001) — but after day 30 the rate of decline did not differ significantly between groups. Quality of life and exacerbations improved with tiotropium. |
| Secondary endpoints | Exacerbations, hospitalisation, St George's Respiratory Questionnaire, mortality |
In patients with COPD, therapy with tiotropium was associated with improvements in lung function, quality of life, and exacerbations during a 4-year period but did not significantly reduce the rate of decline in FEV1.
The trial authors, in the published abstract
The definitive test of whether a bronchodilator alters the natural history of COPD, and the answer was no. The parallel FEV1 curves are the enduring image: a real, sustained shift upward that never becomes a change in slope. That distinction — treating the disease versus modifying it — still frames every conversation about long-term inhaled therapy, and POET-COPD later showed tiotropium's advantage lies in exacerbations rather than decline.
Tashkin DP, Celli B, Senn S, et al. A 4-year trial of tiotropium in chronic obstructive pulmonary disease. N Engl J Med 2008 Oct 9;359(15):1543-54.