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RECRUITING Phase 2

Breathe Easier With Tadalafil Therapy for Dyspnea in COPD-PH

NCT05937854 · View on ClinicalTrials.gov ↗

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.

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

FieldValue
Enrollment Target 126 participants
Start Date 2024-04-01
Est. Completion 2027-12-01
Phase Phase 2

Sponsor

VA Office of Research and Development

1,863 total trials

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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. It is categorized as Phase 2, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 126 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is VA Office of Research and Development, which has 1,863 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

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. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.

Geographic footprint matters for practical reasons: NCT05937854 reports 5 study locations spanning 5 distinct geographic areas — top geographies include Colorado, Georgia, Massachusetts. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.

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. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

What interventions are being tested in trial NCT05937854?

The interventions under investigation include: Placebo (DRUG), Tadalafil (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT05937854?

This trial is sponsored by VA Office of Research and Development, which has 1,863 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

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.

Related

Data sourced from official U.S. government datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial