Effect of Dual Bronchodilation With Umeclidinium/Vilanterol on Patients With COPD, Hyperinflation and Heart Failure

NCT04522596 | Recruiting Phase 4

• 2 other identifiers: CHHEF2019-004427-20
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief 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

Copd; Heart Failure

Keywords

COPD; Heart failure; Hyperinflation

Outcome Measures

Primary Outcomes (2)

• Change from baseline on the increase in exercise stroke volume.

  Baseline-corrected, time-velocity integral (a direct surrogate of SV) during peak exercise, as measured by exercise Doppler-echocardiography.

  0, 14, 42 days (Visits 4, 5 and 7 respectively)

• Change from baseline on the increase in exercise oxygen pulse.

  Maximal oxygen pulse on a cardiopulmonary exercise test on Cycle-ergometer

  0, 14, 42 days (Visits 4, 5 and 7 respectively)

Secondary Outcomes (8)

• Change from baseline on the reduction of resting hyperinflation..

  Screening (-14), 0, 14, 42 days (Visits 4, 5 and 7 respectively)

• Change from baseline on the reduction of dynamic hyperinflation.

  Screening (-14), 0, 14, 42 days (Visits 4, 5 and 7 respectively)

• Change from baseline on resting dyastolic left heart function.

  0, 14, 42 days (Visits 4, 5 and 7 respectively)

• Change from baseline on resting systolic left cardiac function.

  0, 14, 42 days (Visits 4, 5 and 7 respectively)

• Change from baseline on resting right cardiac function.

  0, 14, 42 days (Visits 4, 5 and 7 respectively)

Study Arms (2)

Umeclidinium/vilanterol

EXPERIMENTAL

Umeclidinium/vilanterol 55/22 μg inhaled once a day for 14 days.

Drug: Umeclidinium/vilanterol

Placebo

PLACEBO COMPARATOR

Placebo inhaled once a day for 14 days.

Other: Placebo

Interventions

Umeclidinium/vilanterol DRUG

Umeclidinium/vilanterol 55/22 μg inhaled once a day

Umeclidinium/vilanterol

Placebo OTHER

Placebo inhaled once a day

Placebo

Eligibility Criteria

• Age: 40 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age between 40 and 85 years with a clinical diagnosis of COPD
• Airflow limitation indicated by a screening post-bronchodilator FEV1 \< 80% and \>35% predicted and a post-bronchodilator FEV1/FVC \< 0.7
• Smoking history of at least ten pack-years
• Baseline lung hyperinflation with a residual volume of more than 135% predicted
• Stable heart failure
• Left ventricle ejection fraction in the range of 35% to 55%.
• A suitable ultrasonic window from the apical view
• No exacerbation within 2 months before study recruitment (defined as the use of systemic corticoids, antibiotics, or hospitalization)

You may not qualify if:

• Do not sign the informed consent
• Unstable cardiovascular diseases
• Atrial fibrillation or other arrhythmias requiring treatment
• Unstable ischemic heart disease
• Uncontrolled hypertension
• Patients unable to undergo cardiac MR scanning (claustrophobia or carrying non-MR-compatible devices)
• Patients unable to perform an exercise test (locomotor conditions)

Sponsors & Collaborators

• Luis Puente Maestu: lead

Study Sites (1)

Hospital General Universitario Gregorio Marañón

Madrid, 28007, Spain

RECRUITING

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive; Heart Failure

Interventions

GSK573719; vilanterol

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Heart Diseases; Cardiovascular Diseases

Study Officials

• Luis Puente-Maestu, Prof

  Instituto de Investigación Sanitaria Gregorio Mrañón

  STUDY DIRECTOR

Central Study Contacts

Luis Puente-Maestú, Prof

CONTACT

914703910; luis.puente@salud.madrid.org

Walther I Giron, MD

CONTACT

+34658566028; walter_giron2@hotmail.com

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor

Model Details: Phase IV clinical trial, single-center, double-blind, randomized, two-period crossover, placebo-controlled.

Study Record Dates

• First Submitted: August 17, 2020
• First Posted: August 21, 2020
• Study Start: May 21, 2021
• Primary Completion: December 1, 2024
• Study Completion: December 1, 2024
• Last Updated: February 28, 2024

Record last verified: 2024-02

Locations

ES (1)