Breathe Easier With Tadalafil Therapy for Dyspnea in COPD-PH

Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age35-89
SponsorVA Office of Research and Development

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 volunteers

Qualifiers

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

Design model

Parallel

Treatments tested in this trial

  • Tadalafil

    Drug

    one or 2 encapsulated tablets of encapsulated tadalafil (20MG) po QD

  • Placebo

    Drug

    one or two encapsulated tablets of placebo po QD

Treatment groups

126 Participants
are divided into 2 treatment groups
Group A: PlaceboPlacebo comparator 1 intervention
Group B: tadalafilActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

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.

Time frame
6 months

Secondary outcomes

1

physical activity

assessed by objective average daily step count using actigraphy

Time frame
6 months
2

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

Time frame
6 months
3

functional exercise capacity

6 minute walk distance, defined as the distance walked in meters in 6 minutes

Time frame
6 months

Other outcomes

1

Pulmonary artery to aorta diameter ratio

measured on low dose CT scan

Time frame
6 months
2

Estimated PA systolic pressure in mm Hg

measured by echocardiography

Time frame
6 months

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