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New treatment option for Chronic Obstructive Pulmonary Disease
Official title Breathe Easier With Tadalafil Therapy for Dyspnea in COPD-PH
ClinicalTrials.gov ID: NCT05937854
What this study is testing
What is Tadalafil?
Tadalafil is an investigational medicine, given as an once-daily pill taken by mouth, being studied as a potential treatment for chronic obstructive pulmonary disease.
Also referred to as Adcirca, Cialis.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 2: a mid-size study of how well it works
- Time commitment: about 6 months
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance. You may not know which one you got.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 35 to 89
You may be able to join if
- Outpatients with COPD, defined as airflow limitation with post-bronchodilator obstruction on baseline visit spirometry, identified by FEV1/FVC \< 70%...
- Eligible people must have PH documented as follows:
- 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
You likely can't join if
- Diagnosis of PH in the following subgroups of the updated WHO Clinical Classification:
- Group 1 (Idiopathic, heritable, drug- or toxin-induced, Pulmonary Arterial Hypertension associated with connective tissue disease, congenital heart...
- 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.
- Systemic hypotension in the ambulatory setting (at least 3 reproducible measurements of systolic BP \<89 mmHg, recorded by a health care provider...
See the full eligibility criteria
Who can join
- 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...
- Eligible people must have PH documented as follows:
- 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
- Mean Pulmonary Artery Pressure \> 20 on Right Heart Catheterization done within 6 months of enrollment and when Veteran is clinically stable.
- Eligible people must be dyspneic, as quantitated by a score of at least 20 on the baseline UCSD Shortness of Breath Questionnaire, assessed at the time of the baseline visit.
- Treatment with at least one long-acting bronchodilator for at least 4 weeks, assessed at the time of the baseline visit by chart review and patient interview.
- Age 35-89 Years
- Women of childbearing potential must meet one of the following criteria for the previous three months AND must have a negative pregnancy test on the day of testing. If more than 36 hours since the participant's last...
- have been using a contraceptive measure (an intrauterine device (IUD), a contraceptive implant, oral contraceptives, barrier methods, or abstinence)
- have a male partner with a vasectomy
- have a tubal ligation procedure or a medical diagnosis (such as infertility) or therapies/procedures that precludes pregnancy (such as cancer treatments or endometrial ablation)
- are in a same-sex relationship
- have a male partner not capable of fathering children because of congenital anomalies, other surgery, or medical treatment
- Women who are not considered to be of childbearing potential who have been surgically sterilized (for example: removal of ovaries or fallopian tubes, or hysterectomy) or are post-menopausal (no menstrual period for more...
What rules you out
- Diagnosis of PH in the following subgroups of the updated WHO Clinical Classification:
- 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.
- Systemic hypotension in the ambulatory setting (at least 3 reproducible measurements of systolic BP \<89 mmHg, recorded by a health care provider over 1 week).
- Moderate or severe hepatic impairment (Child-Pugh B and C).
- Severe renal insufficiency (GFR \<30 ml/min/1.73 m2)
- Echocardiography within 6 months showing greater than moderate aortic stenosis (aortic valve area \ 14, Septal e' velocity \ 34 ml/m2). LVEF \< 50%. Any aortic or mitral valve replacement.
- Any acute or chronic impairment (other than dyspnea) that limits ability to comply with the study requirements.
- Current unstable angina, myocardial infarction or stroke within 6 months.
- Requirement for nitrate therapy for any clinical indication.
- Active prescription for a PDE-5 inhibitor or other pulmonary vasodilator other than oxygen as a PH treatment.
- History of the following retinal disorders: retinitis pigmentosa, non-arteritic anterior ischemic optic neuropathy, or crowded optic disc noted on ophthalmology examinations recorded in CPRS.
- Contraindications: PDE-5i allergy, penile anatomical deformations, sickle cell anemia, multiple myeloma, leukemia, bleeding disorders, active peptic ulcer disease, retinitis pigmentosa or other retinal disorders listed...
- Use of any of the following: rifampin, systemic anti-fungal azole agents, protease inhibitors, phenobarbital, dilantin.
- Pregnant, possibly pregnant by report, or if breastfeeding. If found to be pregnant at the study visit, the study visit will not be conducted.
- Pulmonary veno-occlusive disease
- Hypoxia (reproducible ambulatory SaO2 \< 90% on supplemental oxygen at rest recorded by a health care provider over 1 week).
- Diagnosis of Obstructive Sleep Apnea without a prescription for treatment.
- Newly prescribed (less than 4 weeks duration) bronchodilator or diuretic therapy or new enrollment in pulmonary rehabilitation at the time of Baseline.
- Students, VA employees, persons with impaired decision making, illiterate and non-English speakers, and terminally ill patients.
- COPD or CHF exacerbation within the past 4 weeks.
- On-going therapy with doxazosin. Women of childbearing potential must have a documented negative pregnancy test and must be using adequate contraception during the study and for 9 months afterward. Monthly pregnancy...
The study team makes the final eligibility decision.
Where it's taking place
- Aurora, Colorado, United States
- Decatur, Georgia, United States
- Boston, Massachusetts, United States
- Omaha, Nebraska, United States
- Providence, Rhode Island, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The study runs about 6 months per participant, based on its public description. The team confirms the exact schedule and number of visits before you enroll.
Who can join this trial?
This study is enrolling all sexes, 35 years to 89 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Aurora, Colorado, United States; Decatur, Georgia, United States; Boston, Massachusetts, United States; Omaha, Nebraska, United States; Providence, Rhode Island, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.