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Tadalafil for COPD with Pulmonary Hypertension (BETTER COPD-PH Trial)
Phase 2
Waitlist Available
Led By Sharon I Rounds, MD
Research Sponsored by VA Office of Research and Development
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
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.
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 6 months
Awards & highlights
BETTER COPD-PH Trial Summary
This trial will study whether a drug improves shortness of breath in Veterans with COPD and high blood pressure in the lungs. It will also assess its effect on quality of life, exercise endurance, and more.
Who is the study for?
Veterans aged 35-89 with COPD and pulmonary hypertension (PH), experiencing shortness of breath, who are already on long-term bronchodilator therapy. They must have specific heart function and lung capacity as shown by recent tests. Excluded are those with certain heart conditions, recent major cardiovascular events, severe liver or kidney disease, other impairments affecting study compliance, pregnant or breastfeeding women, and those on conflicting medications.Check my eligibility
What is being tested?
The trial is testing if tadalafil can help ease shortness of breath in veterans with COPD-PH compared to a placebo. It also looks at quality of life improvements and physical activity levels. Participants will be randomly assigned to either the drug or placebo group without knowing which one they're receiving and monitored for six months through clinic visits and calls.See study design
What are the potential side effects?
Tadalafil may cause headaches, indigestion, back pain, muscle aches, flushing, stuffy or runny nose. These side effects usually go away after a few hours but back pain and muscle aches can last up to two days.
BETTER COPD-PH Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I have COPD confirmed by a lung function test or chest CT.
BETTER COPD-PH Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 6 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~6 months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
severity of patient-reported dyspnea
Secondary outcome measures
clinically important deterioration
functional exercise capacity
physical activity
Other outcome measures
Estimated PA systolic pressure in mm Hg
Pulmonary artery to aorta diameter ratio
BETTER COPD-PH Trial Design
2Treatment groups
Active Control
Placebo Group
Group I: tadalafilActive Control1 Intervention
one or 2 encapsulated tablets of encapsulated tadalafil (20MG) po QD
Group II: PlaceboPlacebo Group1 Intervention
Encapsulated placebo one or 2 encapsulated tablets po QD
Find a Location
Who is running the clinical trial?
Atlanta VA Medical CenterFED
26 Previous Clinical Trials
69,309 Total Patients Enrolled
VA Office of Research and DevelopmentLead Sponsor
1,609 Previous Clinical Trials
3,306,477 Total Patients Enrolled
VA Boston Healthcare SystemFED
68 Previous Clinical Trials
970,326 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- My heart's valves are not working properly, or my heart is not pumping well.My oxygen levels fall below 90% even with extra oxygen.I am currently taking a protease inhibitor, anti-fungal agent, or rifampin.My liver is not working well (moderate to severe issues).Criterion Summarized: To be eligible for this study, you must have a documented condition called pulmonary hypertension and be 35-89 years old. Additionally, you need to have a score of at least 10 on a shortness of breath questionnaire and have been treated with a long-acting bronchodilator for at least 4 weeks.You have allergies to certain medications, specific medical conditions, or eye disorders.You do not follow the standard guidelines for treating COPD.I have COPD confirmed by a lung function test or chest CT.Students, VA employees, people who have trouble making decisions, cannot read, do not speak English, and people who are very sick and not expected to get better.I have a history of specific eye nerve damage or a crowded optic disc.I have been diagnosed with a specific type of pulmonary hypertension.I need nitrate therapy for my condition.I have been diagnosed with Obstructive Sleep Apnea but haven't been prescribed any treatment.I have had a worsening of my COPD or heart failure in the last 4 weeks.I am currently taking doxazosin.I recently started using a new lung or water pill medication, or joined a lung rehab program.My kidney function is severely reduced.I am currently prescribed medication for pulmonary hypertension other than oxygen.I haven't had a heart attack, stroke, or severe chest pain in the last 6 months.I have been diagnosed with a rare lung blood vessel disorder.My blood pressure is consistently below 89 mmHg.
Research Study Groups:
This trial has the following groups:- Group 1: tadalafil
- Group 2: Placebo
Awards:
This trial has 0 awards, including:Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Is participation in this investigation open to older adults?
"The requirements for potential participants stipulates that they must be between 35 and 89 years of age. For those younger than 18, there are 74 trials available while 1027 exist for persons above 65."
Answered by AI
May I be considered as a potential participant for this trial?
"Patients who suffer from dyspnea and are aged between 35 to 89 can join this medical trial. The total number of participants sought is 126."
Answered by AI
At what number of medical centers is this experiment being conducted?
"Atlanta VA Medical and Rehab Center, Decatur in Georgia; VA Boston Healthcare System Jamaica Plain Campus in Massachusetts; Omaha VA Nebraska-Western Iowa Health Care System in Nebraska are all recruiting patients for this trial. Additionally, there are 5 other sites located throughout the US available for enrolment."
Answered by AI
Is this experiment still recruiting participants?
"According to clinicaltrials.gov, the recruitment process for this trial has concluded and it is not currently seeking participants. The first posting was on August 1st 2023, with the last update being July 7th 2023. Nevertheless, over a thousand other trials are presently open that require volunteers."
Answered by AI
Has tadalafil been officially sanctioned by the FDA?
"Within our safety assessment, tadalafil received a rating of 2 since it is in Phase 2 trials and there are only some indications that the drug is safe."
Answered by AI
Who else is applying?
What site did they apply to?
Providence VA Medical Center, Providence, RI
What portion of applicants met pre-screening criteria?
Met criteria
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