Comparative Efficacy of Once-daily LAMA/LABA Combinations Versus Tiotropium on Constant-work-rate Cycle Endurance in COPD

Summary

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 respiratory function, exercise tolerance, and quality of life. The study aims to determine whether dual bronchodilation with LABA/uLAMA combinations provides superior improvements in exercise performance and overall efficiency compared to tiotropium alone. Results may help guide clinical decision-making and optimize cost-effectiveness in COPD management.

Timeline

Start

2024-03-11

Primary completion

2025-02-07

Completion

2027-09-01

Publications

• Results Mejza F.: Postępowanie w przewlekłej obturacyjnej chorobie płuc. Podsumowanie wytycznych Global Initiative for Obstructive Lung Disease (GOLD) 2020. Med. Prakt., 2020; 2: 38-50
• Results Koarai A, Sugiura H, Yamada M, Ichikawa T, Fujino N, Kawayama T, Ichinose M. Treatment with LABA versus LAMA for stable COPD: a systematic review and meta-analysis. BMC Pulm Med. 2020 Apr 29;20(1):111. doi: 10.1186/s12890-020-1152-8.
• Results Bourdin A, Burgel PR, Chanez P, Garcia G, Perez T, Roche N. Recent advances in COPD: pathophysiology, respiratory physiology and clinical aspects, including comorbidities. Eur Respir Rev. 2009 Dec;18(114):198-212. doi: 10.1183/09059180.00005509. No abstract available.
• Results Brashier BB, Kodgule R. Risk factors and pathophysiology of chronic obstructive pulmonary disease (COPD). J Assoc Physicians India. 2012 Feb;60 Suppl:17-21. No abstract available.
• Results 1. World Health Organization. Chronic Obstructive Pulmonary Disease. Key Facts https://www.who.int/news-room/fact-sheets/detail/chronic-obstructive-pulmonary-disease- (copd)

Drugs

Indications