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Breathe Easier With Tadalafil Therapy for Dyspnea in COPD-PH

NCT05937854 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 126

Last updated 2026-05-15

No results posted yet for this study

Summary

The investigators will study whether the drug tadalafil improves shortness of breath in 126 Veterans with Chronic Obstructive Pulmonary Disease (COPD) and high blood pressure in the lungs. The investigators will also assess whether tadalafil improves quality of life, home daily physical activity, exercise endurance, the frequency of acute flares of COPD, blood pressure in the lungs, and lung function. Veterans who enroll in the trial will be allocated by chance to either active tadalafil or an inactive identical capsule (placebo). Neither the Veteran nor the investigator will know whether the Veteran is taking tadalafil or placebo. Veterans will be followed closely in clinic or by telephone at 1, 2, 3, 4, 5, and 6 months, with attention to side effects and safety. At 1,3, and 6 months the investigators will repeat the questionnaires and testing of blood pressures in the lung and lung function. The investigators anticipate that the results of this study will determine whether tadalafil improves shortness of breath when added to usual medications for COPD.

Conditions

Interventions

DRUG

Tadalafil

one or 2 encapsulated tablets of encapsulated tadalafil (20MG) po QD

DRUG

Placebo

one or two encapsulated tablets of placebo po QD

Sponsors & Collaborators

  • VA Boston Healthcare System

    collaborator FED

  • Atlanta VA Medical Center

    collaborator FED

  • VA Eastern Colorado Health Care System

    collaborator FED

  • VA Nebraska Western Iowa Health Care System

    collaborator FED

  • VA Office of Research and Development

    lead FED

Principal Investigators

  • Sharon I Rounds, MD · Providence VA Medical Center, Providence, RI

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
35 Years
Max Age
89 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-04-01
Primary Completion
2029-03-01
Completion
2029-03-01
FDA Drug
Yes

Countries

  • United States

Study Locations

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Entities

Drugs
Diseases

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 NCT05937854 on ClinicalTrials.gov