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NCT05937854 · ClinicalTrials.gov registry record · Phase 2
Breathe Easier With Tadalafil Therapy for Dyspnea in COPD-PH
A Phase 2 study of Chronic Obstructive Pulmonary Disease and Pulmonary Hypertension, sponsored by VA Office of Research and Development.
- Recruiting
- Registry status
- Phase 2
- Development phase
- 126
- Enrollment target
- 5
- Study locations
NCT05937854 is a Phase 2 study of Chronic Obstructive Pulmonary Disease and Pulmonary Hypertension that is actively recruiting participants, run by VA Office of Research and Development. The registered enrollment target is 126 participants, below the 1,753-participant average among 86 other Chronic Obstructive Pulmonary Disease trials with a reported enrollment target (93% lower). The trial reports 5 study locations across 5 states.
The verdict
NCT05937854, a Phase 2 study of Chronic Obstructive Pulmonary Disease and Pulmonary Hypertension, is actively recruiting participants, sponsored by VA Office of Research and Development.
- RECRUITING
- Registry status
- Phase 2
- Development phase
- 126 participants
- Enrollment target
- 5
- Study locations
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 Studied
Interventions
- DRUG Placebo
- DRUG Tadalafil
Study Locations (5)
Colorado
- Rocky Mountain Regional VA Medical Center, Aurora, CO - Aurora
Georgia
- Atlanta VA Medical and Rehab Center, Decatur, GA - Decatur
Massachusetts
- VA Boston Healthcare System Jamaica Plain Campus, Jamaica Plain, MA - Boston
Nebraska
- Omaha VA Nebraska-Western Iowa Health Care System, Omaha, NE - Omaha
Rhode Island
- Providence VA Medical Center, Providence, RI - Providence
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 126 participants |
| Start Date | 2024-04-01 |
| Est. Completion | 2027-12-01 |
| Phase | Phase 2 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT05937854
The ClinicalTrials.gov registry entry for NCT05937854 describes a study currently listed as recruiting, categorized as Phase 2. The registered enrollment target is 126 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 1,753-participant average among 86 other Chronic Obstructive Pulmonary Disease trials with a reported enrollment target (93% lower). The listed sponsor is VA Office of Research and Development, which has 1,668 total studies on file at ClinicalTrials.gov.
The record links to 3 conditions, with Chronic Obstructive Pulmonary Disease appearing as the primary indexed condition, and to 2 interventions - of which Placebo is the first listed.
NCT05937854 reports 5 study locations spanning 5 distinct geographic areas - top geographies include Colorado, Georgia, Massachusetts.
Frequently Asked Questions
What is clinical trial NCT05937854 about?
NCT05937854 is a clinical study titled "Breathe Easier With Tadalafil Therapy for Dyspnea in COPD-PH". 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, ex...
What is the current status of trial NCT05937854?
This trial is currently recruiting. It is a Phase 2 study. The enrollment target is 126 participants. The study started on 2024-04-01. Estimated completion is 2027-12-01.
What conditions does trial NCT05937854 study?
This clinical trial studies the following conditions: Chronic Obstructive Pulmonary Disease, Pulmonary Hypertension, Dyspnea.
What interventions are being tested in trial NCT05937854?
The interventions under investigation include: Placebo (DRUG), Tadalafil (DRUG).
Who is sponsoring clinical trial NCT05937854?
This trial is sponsored by VA Office of Research and Development, which has 1,668 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05937854 being conducted?
This trial has 5 study locations across Colorado, Georgia, Massachusetts, Nebraska, Rhode Island. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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