COPD Trial Compares Anoro, Ultibro, Spiolto to Tiotropium
ClinicalTrials.gov Studies
Summary
ClinicalTrials.gov registered a Phase 4 crossover trial (NCT07541378) at Medical University of Białystok and University Hospital Pulmonology Outpatient Clinic in Poland. The study will directly compare three LABA/LAMA fixed-dose combinations (umeclidinium/vilanterol, indacaterol/glycopyrronium, tiotropium/olodaterol) against tiotropium monotherapy in approximately 100 stable COPD patients over four 28-day treatment periods with 7-day washouts.
What changed
This ClinicalTrials.gov entry registers a prospective, randomized, open-label, four-period crossover trial evaluating the comparative efficacy of three FDA-approved LABA/LAMA fixed-dose combinations versus tiotropium alone on constant-workrate cycle endurance in COPD patients.
Healthcare providers and clinical investigators conducting bronchodilator studies may reference this trial for pharmacoeconomic and exercise-capacity outcome data. The trial's comprehensive assessment battery (spirometry, CPET, 6MWT, validated questionnaires) will generate comparative evidence across these widely-used COPD maintenance therapies.
Archived snapshot
Apr 21, 2026GovPing captured this document from the original source. If the source has since changed or been removed, this is the text as it existed at that time.
Comparative Efficacy of Once-daily LAMA/LABA Combinations Versus Tiotropium on Constant-work-rate Cycle Endurance in COPD
N/A NCT07541378 Kind: NA Apr 21, 2026
Abstract
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 will include standard clinical examinations, lung function testing (spirometry, body plethysmography, DLCO, multiple-breath washout), cardiopulmonary exercise testing (CPET) on a cycle ergometer, the 6-minute walk test, validated questionnaires (SGRQ, CAT, mMRC, BODE index), laboratory tests, and imaging. These procedures are part of routine COPD evaluation and will allow detailed monitoring of...
Conditions: COPD (Chronic Obstructive Pulmonary Disease)
Interventions: Tiotropium, Olodaterol, Umeclidinium, Vilanterol, Indacaterol, Glycopyrronium
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