No phaseSuspended
Comparative Efficacy of Once-daily LAMA/LABA Combinations Versus Tiotropium on Constant-work-rate Cycle Endurance in COPD (COMPETE)
Comparative Efficacy of Once-daily LAMA/LABA Combinations Versus Tiotropium on Constant-work-rate Cycle Endurance in COPD: Randomised Crossover Study (COMPETE)
- Sponsor
- Medical University of Bialystok (Academic or other)
- Enrolment
- 100 planned
- Conditions
- COPD (Chronic Obstructive Pulmonary Disease)
- Interventions
- Tiotropium; Olodaterol; Umeclidinium; Vilanterol; Indacaterol; Glycopyrronium
- Ages
- adults, older adults
- Registry
- NCT07541378
Full record on ClinicalTrials.gov
From the registry
This study is designed to directly compare the effects of widely available long-acting bronchodilator therapies in patients with chronic obstructive pulmonary disease (COPD). The trial evaluates three fixed-dose combinations of a long-acting beta-2 agonist and a long-acting muscarinic antagonist (LABA/uLAMA)-umeclidinium/vilanterol (Anoro® Ellipta), indacaterol/glycopyrronium (Ultibro® Breezhaler), and tiotropium/olodaterol (Spiolto® Respimat)-against tiotropium (Spiriva®), a long-acting muscarinic antagonist (LAMA) used as monotherapy. The primary aim is to assess their impact on exercise capacity, with additional evaluation of pharmacoeconomic outcomes. The study follows a prospective, randomized, open-label, four-period crossover design. Approximately 100 patients with stable COPD will be enrolled from the 2nd Department of Pulmonology and Tuberculosis, Medical University of Białystok, and the University Hospital Pulmonology Outpatient Clinic. Each treatment will last 28 days, separated by a 7-day wash-out period, so that every participant will receive each therapy. Assessments…
Primary outcomes
- Endurance time during constant-work-rate cycle ergometry (CWRCE)
History
Study completion expected
Last registry update
Registered
Primary completion
Started