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 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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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 equations), OR any emphysema on chest CT noted in a clinical radiology report confirmed by study investigator review.
Main Pulmonary Artery/Ascending Aorta (PA/A) diameter > 0.90 on clinically available CT scans within 12 months OR
Main Pulmonary Artery diameter > 30.8mm on clinically available CT scans within 12 months OR
outpatient echocardiography done within 6 months of enrollment demonstrating PA sys > 34 mmHg OR
Disqualifiers
Group 1 (Idiopathic, heritable, drug- or toxin-induced, Pulmonary Arterial Hypertension associated with connective tissue disease, congenital heart disease)
Group 2 (left atrial hypertension)
Group 3 PH not attributable to COPD
Group 4 (chronic thromboembolic PH) or other forms of PH not associated with primary lung disease.
Trial design
Parallel
Treatments tested in this trial
Tadalafil
Drugone or 2 encapsulated tablets of encapsulated tadalafil (20MG) po QD
Placebo
Drugone or two encapsulated tablets of placebo po QD
Treatment groups
Trial outcomes
Primary outcomes
severity of patient-reported dyspnea
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.
Secondary outcomes
physical activity
assessed by objective average daily step count using actigraphy
clinically important deterioration
Defined as the presence or absence of at least one of the following: increase \> 4U in the total health-related quality of life (St. George's Respiratory Questionnaire, SGRQ), decreased FEV1 of \> 100mL, or moderate-severe acute exacerbation of COPD
functional exercise capacity
6 minute walk distance, defined as the distance walked in meters in 6 minutes
Other outcomes
Pulmonary artery to aorta diameter ratio
measured on low dose CT scan
Estimated PA systolic pressure in mm Hg
measured by echocardiography
Sponsors and contacts
Click on the lead sponsor to view all of their trials.
VA Office of Research and Development
Lead sponsor
VA Boston Healthcare System
Collaborator
Atlanta VA Medical Center
Collaborator
VA Eastern Colorado Health Care System
Collaborator
VA Nebraska Western Iowa Health Care System
Collaborator