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Updated June 2026 · ClinicalTrials.gov

RECRUITINGPhase 2INTERVENTIONAL

Breathe Easier With Tadalafil Therapy for Dyspnea in COPD-PH

Effect of PDE5 Inhibitor on Respiratory Symptoms in COPD Complicated by Pulmonary Hypertension

Breathe Easier With Tadalafil Therapy for Dyspnea in COPD-PH (NCT05937854) is a Phase 2 interventional studying Chronic Obstructive Pulmonary Disease and Pulmonary Hypertension, sponsored by VA Office of Research and Development. RECRUITING as of the most recent ClinicalTrials.gov update. Talk to your doctor before contacting the trial site.

Important: This information is not medical advice. Talk to your doctor about whether a clinical trial is right for you.

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.

What Stage of Research Is This?

Phase 2 trials evaluate whether a treatment actually works against Chronic Obstructive Pulmonary Disease and continue monitoring side effects. Phase 2 enrolls larger groups (typically 100–300 patients) and produces the first real efficacy signal. A successful Phase 2 readout is what unlocks the much larger Phase 3 confirmatory trials needed for FDA approval.

This trial is currently recruiting participants. The sponsor has registered the study with ClinicalTrials.gov as actively enrolling, which means new applicants who meet the eligibility criteria can be considered for screening. Trial status can change between updates — confirm current recruiting status with the study contact before traveling for a screening visit.

Target enrollment of 126 participants puts this in the typical range for a Phase 2-style efficacy study or a moderate Phase 3 trial in a focused Chronic Obstructive Pulmonary Disease subpopulation. At this scale, the study has enough statistical power to detect a clear treatment effect but is not the largest cohort in the field.

Who May Be Eligible (Plain English)

Who May Qualify: 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 equations), OR any emphysema on chest CT noted in a clinical radiology report confirmed by study investigator review. 2. Eligible subjects must have PH documented as follows: 1. Main Pulmonary Artery/Ascending Aorta (PA/A) diameter \> 0.90 on clinically available CT scans within 12 months OR 2. Main Pulmonary Artery diameter \> 30.8mm on clinically available CT scans within 12 months OR 3. outpatient echocardiography done within 6 months of enrollment demonstrating PA sys \> 34 mmHg OR 4. Mean Pulmonary Artery Pressure \> 20 on Right Heart Catheterization done within 6 months of enrollment and when Veteran is clinically stable. 3. Eligible subjects 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. 4. 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. 5. Age 35-89 Years 6. 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 pregnancy test, they will be tested again at the study visit. 1. have been using a contraceptive measure (an intrauterine device (IUD), a contraceptive implant, oral contraceptives, barrier methods, or abstinence) 2. have a male partner with a vasectomy 3. 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) ...See full criteria on ClinicalTrials.gov Always talk to your doctor about whether this trial is right for you.

These are translations of the protocol\'s inclusion and exclusion criteria, simplified for patients and caregivers. The original clinical text appears below. Eligibility is ultimately confirmed by the trial site\'s screening process — this summary is a starting point for a conversation with your doctor, not a final determination.

Original Eligibility Criteria

View original clinical language
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 equations), OR any emphysema on chest CT noted in a clinical radiology report confirmed by study investigator review. 2. Eligible subjects must have PH documented as follows: 1. Main Pulmonary Artery/Ascending Aorta (PA/A) diameter \> 0.90 on clinically available CT scans within 12 months OR 2. Main Pulmonary Artery diameter \> 30.8mm on clinically available CT scans within 12 months OR 3. outpatient echocardiography done within 6 months of enrollment demonstrating PA sys \> 34 mmHg OR 4. Mean Pulmonary Artery Pressure \> 20 on Right Heart Catheterization done within 6 months of enrollment and when Veteran is clinically stable. 3. Eligible subjects 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. 4. 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. 5. Age 35-89 Years 6. 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 pregnancy test, they will be tested again at the study visit. 1. have been using a contraceptive measure (an intrauterine device (IUD), a contraceptive implant, oral contraceptives, barrier methods, or abstinence) 2. have a male partner with a vasectomy 3. 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) 4. are in a same-sex relationship 5. have a male partner not capable of fathering children because of congenital anomalies, other surgery, or medical treatment 7. 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 than 6 months). Exclusion Criteria: 1. Diagnosis of PH in the following subgroups of the updated WHO Clinical Classification: 1. Group 1 (Idiopathic, heritable, drug- or toxin-induced, Pulmonary Arterial Hypertension associated with connective tissue disease, congenital heart disease) 2. Group 2 (left atrial hypertension) 3. Group 3 PH not attributable to COPD 4. Group 4 (chronic thromboembolic PH) or other forms of PH not associated with primary lung disease. 2. 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). 3. Moderate or severe hepatic impairment (Child-Pugh B and C). 4. Severe renal insufficiency (GFR \<30 ml/min/1.73 m2) 5. Echocardiography within 6 months showing greater than moderate aortic stenosis (aortic valve area \<1.0 cm2), greater than moderate mitral regurgitation, or diastolic dysfunction (Any two of the following: Average E/e' \>14, Septal e' velocity \< 7 or lateral e' velocity \<10, LA volume index \> 34 ml/m2). LVEF \< 50%. Any aortic or mitral valve replacement. 6. Any acute or chronic impairment (other than dyspnea) that limits ability to comply with the study requirements. 7. Current unstable angina, myocardial infarction or stroke within 6 months. 8. Requirement for nitrate therapy for any clinical indication. 9. Active prescription for a PDE-5 inhibitor or other pulmonary vasodilator other than oxygen as a PH treatment. 10. 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. 11. 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 above. In accordance with 38 USC 7332, this information will be kept confidential and will not be disclosed in presentations, publications, or any other dissemination of the study results, or to anyone outside of the IRB-approved study team. 12. Use of any of the following: rifampin, systemic anti-fungal azole agents, protease inhibitors, phenobarbital, dilantin. 13. Pregnant, possibly pregnant by report, or if breastfeeding. If found to be pregnant at the study visit, the study visit will not be conducted. 14. Pulmonary veno-occlusive disease 15. Hypoxia (reproducible ambulatory SaO2 \< 90% on supplemental oxygen at rest recorded by a health care provider over 1 week). 16. Diagnosis of Obstructive Sleep Apnea without a prescription for treatment. 17. Newly prescribed (less than 4 weeks duration) bronchodilator or diuretic therapy or new enrollment in pulmonary rehabilitation at the time of Baseline. 18. Students, VA employees, persons with impaired decision making, illiterate and non-English speakers, and terminally ill patients. 19. COPD or CHF exacerbation within the past 4 weeks. 20. 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 tests will be done, and compliance with contraception use will be documented at the telephone and clinic visits. Should a female become pregnant at any time during the study, the study medication will be discontinued. Doxazosin use will be defined as current active prescription and usage of Doxazosin or planned trial (pending prescription) of Doxazosin for treatment of benign prostatic hypertrophy, systemic hypertension, or other indication. A list of alpha-1 antagonists (ex. prazosin, doxazosin, tamulosin, terazosin, etc.) will be included in the patient study medication handout to prompt the patient to avoid any new usage of these drugs during the trial period. On-going therapy with doxazosin is an exclusion criterion due to greater risk of hypotension.

Treatments Being Tested

DRUG

Tadalafil

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

DRUG

Placebo

one or two encapsulated tablets of placebo po QD

Locations (5)

Trial sites listed on ClinicalTrials.gov for this study. Site activation status can vary — confirm with the specific site before traveling for a screening visit.

Rocky Mountain Regional VA Medical Center, Aurora, CO
Aurora, Colorado, United States
Atlanta VA Medical and Rehab Center, Decatur, GA
Decatur, Georgia, United States
VA Boston Healthcare System Jamaica Plain Campus, Jamaica Plain, MA
Boston, Massachusetts, United States
Omaha VA Nebraska-Western Iowa Health Care System, Omaha, NE
Omaha, Nebraska, United States
Providence VA Medical Center, Providence, RI
Providence, Rhode Island, United States

How to Talk to Your Doctor About This Trial

Bring the printable summary of this trial — including the NCT ID (NCT05937854), the sponsor (VA Office of Research and Development), and the key eligibility criteria — to your next appointment. Your doctor can review the inclusion and exclusion criteria against your medical history, lab values, and current treatments to assess whether you are likely to qualify. They can also help you weigh whether trial participation makes sense alongside your existing care plan.

Useful questions to walk through together: What does the trial protocol require beyond standard care? How long is the active treatment phase, and how long is follow-up? Are there study visits at sites I can reach? Who pays for the trial-specific procedures, and who pays for standard-of-care portions? See our 25 questions to ask about clinical trials guide for a more complete checklist.

Authoritative Sources

The official record for this trial lives on ClinicalTrials.gov — the federal registry maintained by the National Library of Medicine at NIH. For background on how this trial fits into the FDA approval pathway, see the FDA drug approval process. For oncology-specific guidance for patients considering trials, the National Cancer Institute publishes patient-oriented overviews. International trial registries are aggregated by the WHO ICTRP.

Frequently Asked Questions

What is the NCT05937854 clinical trial studying?

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 … The full protocol is registered on ClinicalTrials.gov and includes the primary outcome measures, eligibility criteria, and study endpoints.

Who can participate in NCT05937854?

Eligibility for this trial depends on the specific inclusion and exclusion criteria set by the sponsor. The plain-English summary above translates the most important criteria into accessible language; the official clinical text is preserved in the collapsible section underneath. Whether you fit any specific trial is a medical decision your doctor needs to confirm — bring the trial information to your treating physician for a full review against your medical history.

How do I contact the trial site for NCT05937854?

Contact information registered with ClinicalTrials.gov is shown in the sidebar of this page. Before reaching out, confirm with your treating physician that this trial is appropriate for your situation. The trial site will then walk you through the screening process to determine final eligibility.

Is participating in a clinical trial safe?

Clinical trials in the United States are regulated by the FDA and overseen by Institutional Review Boards (IRBs) that review the protocol for safety. Risk varies by trial — Phase 1 studies test new treatments in humans for the first time, while Phase 3 trials use treatments that have already passed earlier safety screening. The informed consent document for any specific trial details the known risks and what to expect. Discuss those risks with your physician before deciding whether to participate.

Where can I verify the data on this page?

Every detail on this page comes directly from the ClinicalTrials.gov API. Click "View on ClinicalTrials.gov" in the sidebar to see the official, unmodified record. The federal record is always authoritative; this page is a structured presentation with a plain-English eligibility translation. For background on how clinical trials are regulated, see the FDA drug approval process documentation.

How This Page Is Built

Every field on this page is pulled directly from the ClinicalTrials.gov API v2 — no estimates, no proxies. The plain-English eligibility translation is generated from the original protocol text and reviewed for fidelity to the underlying clinical criteria. The original clinical text remains visible in the collapsible section above so users and clinicians can verify the translation. Read the full methodology for the data pipeline and known limitations.

Source: ClinicalTrials.gov API v2 record for NCT05937854. Maintained by the National Library of Medicine at NIH. Public domain. Cite as: "TrialFinderData. NCT05937854. Data: ClinicalTrials.gov."

Medical disclaimer: This page is informational, not medical advice. Talk to your doctor about whether a clinical trial is right for you.

Last updated 2026-06-07 · Data from ClinicalTrials.gov.