SuspendedNot Applicable

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

Stopped: Recruitment was temporarily suspended pending additional funding and activation of additional study centers. The pilot phase has been completed and is currently being evaluated. The suspension was not related to safety concerns.

Poland100 participantsStarted 2024-03-11

Plain-language 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.

Who can participate

Age range30 Years – 70 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: Signed informed consent for study participation Diagnosis of COPD Age ≥30 years and ≤70 years Post-bronchodilator FEV₁ ≤80% and ≥30% predicted BMI ≥15 kg/m² and \<40 kg/m² Exclusion Criteria: * Lack of informed consent for study participation No confirmed diagnosis of COPD Age \<30 years or \>70 years FEV₁ \>80% or \<30% predicted BMI \<15 kg/m² or ≥40 kg/m² Inability to self-care or lack of long-term family or caregiver support Recent myocardial infarction (within 3 months before enrollment) Unstable angina Uncontrolled arrhythmias detected on ECG at screening or immediately before CPET Critical aortic stenosis at screening Acute myocarditis or pericarditis Acute cardiovascular conditions such as pulmonary embolism, aortic dissection, or endocarditis Acute systemic conditions that may interfere with exercise testing or worsen under stress (e.g., infections, renal failure, thyrotoxicosis) Deep vein thrombosis Uncontrolled asthma Physical disability preventing safe and adequate CPET performance Cognitive impairment precluding cooperation

What they're measuring

Endurance time during constant-work-rate cycle ergometry (CWRCE)

Timeframe: Baseline and after 28 days of each treatment period

Trial details

NCT IDNCT07541378

SponsorMedical University of Bialystok

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2025-02-07