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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: Recruiting Phase 2 study of Chronic Obstructive Pulmonary Disease and Pulmonary Hypertension, sponsored by VA Office of Research and Development.
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. According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
Assessed by the University of California-San Diego Shortness of Breath Questionnaire (UCSD-SOBQ). Score range = 0-120 with higher scores indicating worse outcomes. Minimum score for inclusion in the study is 10.
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 |
What NCT05937854 shows while recruiting
NCT05937854 is an interventional study that assigns participants to a tested intervention. The registered 126 participants enrollment target is mid-sized for trials with a published cap, below the 1,753-participant average among 86 other Chronic Obstructive Pulmonary Disease trials with a reported enrollment target (93% lower).
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 lists 5 locations in 5 states (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.
Learn More About Clinical Trials
Similar trials for Chronic Obstructive Pulmonary Disease
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT05937854's enrollment target sits among peer trials
126 46th of 86 higher than 40 of 86 other Chronic Obstructive Pulmonary Disease trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Chronic Obstructive Pulmonary Disease trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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