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

No results posted yet for this study

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

More Related Trials

Entities

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 NCT04522596 on ClinicalTrials.gov