Tadalafil for Shortness of Breath in COPD and Pulmonary Hypertension

Breathe Easier With Tadalafil Therapy for Dyspnea in COPD-PH

Recruiting Phase 2 Interventional Study
Chronic Obstructive Pulmonary Disease Pulmonary Hypertension Dyspnea
Prior Safety Data This treatment has already been tested in at least one earlier human trial.
Ready to participate?

Review the details below, then apply to join this clinical trial.

At a Glance
Age
35 – 89
Sex
Any
Trial phase
Phase 2
Study type
Interventional
Purpose
Treatment
Participants needed
126 (estimated)
Sponsor
VA Office of Research and Development · Federal
Who this trial is looking for

This trial is looking for veterans with Chronic Obstructive Pulmonary Disease (COPD) and high blood pressure in the lungs who experience shortness of breath. Participants will take either the drug tadalafil or a placebo and will be monitored over six months to see if their breathing improves.

Are You a Good Fit for This Trial?
Must be taking Long-acting bronchodilator
Must not be taking Doxazosin
Rules you out Severe renal insufficiencySevere liver impairmentPulmonary veno-occlusive disease

You may be able to join if

  • I have been diagnosed with COPD.
  • I have high blood pressure in my lungs.
  • I experience shortness of breath.
  • I am taking at least one long-acting bronchodilator.
  • I am between 35 and 89 years old.
  • I have been using contraception if I am a woman of childbearing potential.
  • I have a negative pregnancy test if I am a woman of childbearing potential.

You may not be able to join if

  • I have been diagnosed with certain types of pulmonary hypertension.
  • I have low blood pressure.
  • I have severe liver or kidney problems.
  • I have severe heart problems.
  • I have certain eye disorders.
  • I am currently pregnant or breastfeeding.
  • I had a COPD or heart failure flare-up in the past four weeks.
  • I am taking certain disallowed medications.

Summarized in plain language from this trial's official eligibility criteria. The full criteria are further down this page — only the research team can confirm whether you qualify.

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Check Your Eligibility
About This Trial
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 funct…
Trial Locations
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Eligibility Criteria
Inclusion Criteria: 1. Outpatients with COPD, defined as airflow limitation with post-bronchodilator obstruction on baseline visit spirometry, identified by FEV1/FVC \< 70% or \< the lower limit of normal (5th percentile of a normal population based on Global Lung Function Initiative reference equa…
Contacts

Sharon I Rounds, MD

(401) 273-7100

sharon.rounds@va.gov

CONTACT

Ronald H Goldstein, MD

(857) 203-6578

Ronald.Goldstein@va.gov

CONTACT