Effect of Dual Bronchodilation With Umeclidinium/Vilanterol on Patients With COPD, Hyperinflation and Heart Failure
NCT04522596 · Status: RECRUITING · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 60
Last updated 2024-02-28
Summary
Double-blind, randomized, two-period crossover, placebo-controlled, single-center study, to determine the effect of umeclidinium/vilanterol 55/22 μg compared with placebo on the increase in left systolic chamber function during exercise in patients with COPD, lung hyperinflation and mild to moderate left ventricular dysfunction.
Conditions
Interventions
- DRUG
-
Umeclidinium/vilanterol
Umeclidinium/vilanterol 55/22 μg inhaled once a day
- OTHER
-
Placebo
Placebo inhaled once a day
Sponsors & Collaborators
-
Luis Puente Maestu
lead OTHER
Principal Investigators
-
Luis Puente-Maestu, Prof · Instituto de Investigación Sanitaria Gregorio Mrañón
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- QUADRUPLE
- Model
- CROSSOVER
Eligibility
- Min Age
- 40 Years
- Max Age
- 85 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2021-05-21
- Primary Completion
- 2024-12-31
- Completion
- 2024-12-31
Countries
- Spain
Study Locations
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