What question did this study set out to answer?

This research evaluates the outcomes of tiotropium versus salmeterol in maintaining COPD treatment for GOLD II and maintenance-naïve patients.

March 14, 2026

Tiotropium vs salmeterol in GOLD II and maintenance-naïve COPD patients: Subgroup analyses of POET-COPD™ trial

Key Points

This research evaluates the outcomes of tiotropium versus salmeterol in maintaining COPD treatment for GOLD II and maintenance-naïve patients.
Conducted a 1-year randomized, double-blind, double-dummy, parallel-group trial
Included patients with a history of COPD and specific baseline characteristics
Evaluated the primary endpoint of time to first exacerbation
Tiotropium prolonged time to first exacerbation in both subgroups with a hazard ratio of 0.88 for GOLD II and 0.79 for maintenance-naïve
Exacerbation rates per patient-year showed a trend favoring tiotropium in GOLD II: 0.55 vs 0.60
Significant reduction in exacerbation rates for maintenance-naïve patients with tiotropium at 0.38 compared to 0.49 for salmeterol

Abstract

Background: Chronic obstructive pulmonary disease (COPD) guidelines recommend long-acting bronchodilator (muscarinic antagonist or β 2 -agonist) maintenance therapy from GOLD stage II (moderate) disease onwards. Aims and objectives: Prespecified subgroup analyses of POET-COPD™ trial, evaluating exacerbation outcomes of tiotropium (18 μg qd) vs salmeterol (50 μg bid), in a) GOLD II and b) maintenance-naïve (not previously receiving maintenance therapy) COPD patients. Methods: 1-yr randomized, double-blind, double-dummy, parallel-group, multicenter trial. Inclusion criteria: COPD, smoking history >10 pk-yrs, post-bronch forced expiratory volume in 1s (FEV 1 ) <70% pred, FEV 1 /forced vital capacity (FVC) <0.7, history of ≥1 moderate or severe exacerbation in prior year. Primary endpoint: time to first exacerbation. Results: Of 7376 patients randomized and treated, 3614 were GOLD II and 1343 maintenance naïve at randomization. GOLD II: 69.3% men, age 63.2 yrs, 37.3 pk-yrs. Maintenance naïve: 72.2% men, age 60.9 yrs, 34.6 pk-yrs. Tiotropium prolonged time to first exacerbation in both GOLD II and maintenance-naïve groups: hazard ratio (95% confidence interval CI), tiotropium vs salmeterol: 0.88 (0.79-0.99), P =0.028 and 0.79 (0.65-0.97), P =0.028. Exacerbation rates (per pt-yr), tiotropium vs salmeterol: GOLD II, 0.55 vs 0.60, rate ratio (RR) (95% CI) 0.91 (0.81-1.01), P =0.072; maintenance naïve, 0.38 vs 0.49, RR (95% CI) 0.77 (0.63-0.94), P <0.05. Conclusion: Similar to overall cohort in POET-COPD™, tiotropium improved exacerbation outcomes vs salmeterol in GOLD II and maintenance-naïve subgroups of COPD patients with an exacerbation history. Funded by Boehringer Ingelheim/Pfizer

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