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

NCT07541378 · Status: SUSPENDED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 100

Last updated 2026-04-21

No results posted yet for this study

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.

Conditions

  • COPD (Chronic Obstructive Pulmonary Disease)

Interventions

DRUG

Tiotropium

Tiotropium bromide, long-acting muscarinic antagonist (LAMA). Administered as 2.5 μg per actuation, 2 inhalations once daily via Respimat inhaler for 28 days.

DRUG

Olodaterol

Olodaterol, long-acting beta2-agonist (LABA). Administered as 2.5 μg per actuation, 2 inhalations once daily via Respimat inhaler for 28 days in combination with tiotropium.

DRUG

Umeclidinium

Umeclidinium bromide, long-acting muscarinic antagonist (LAMA). Administered as 55 μg, 1 inhalation once daily via Ellipta inhaler for 28 days in combination with vilanterol.

DRUG

Vilanterol

Vilanterol, long-acting beta2-agonist (LABA). Administered as 22 μg, 1 inhalation once daily via Ellipta inhaler for 28 days in combination with umeclidinium.

DRUG

Indacaterol

Indacaterol maleate, long-acting beta2-agonist (LABA). Administered as 110 μg, 1 capsule inhaled once daily via Breezhaler device for 28 days in combination with glycopyrronium.

DRUG

Glycopyrronium

Glycopyrronium bromide, long-acting muscarinic antagonist (LAMA). Administered as 54 μg, 1 capsule inhaled once daily via Breezhaler device for 28 days in combination with indacaterol.

Sponsors & Collaborators

  • Medical University of Bialystok

    lead OTHER

Principal Investigators

  • Robert M Mroz, professor · Medical University of Bialystok

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
CROSSOVER

Eligibility

Min Age
30 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-03-11
Primary Completion
2025-02-07
Completion
2027-09-01

Countries

  • Poland

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07541378 on ClinicalTrials.gov