Is NCT05937854 recruiting in Aurora, CO?

Yes, NCT05937854 is currently recruiting participants at its Aurora, CO location. This copd clinical trial is actively enrolling qualified participants.

How do I join the copd clinical trial in Aurora?

To join this clinical trial in Aurora, complete the eligibility form on this page. A study coordinator will contact you to discuss next steps and determine if you qualify.

Is participation in this Aurora clinical trial free?

Yes, all study-related care is provided at no cost to qualified participants. Many studies also offer compensation for time and travel expenses.

COPD Clinical Trial in Aurora, CO

About This COPD Study in Aurora

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 i

Sponsor: VA Office of Research and Development

Who Can Participate

Inclusion Criteria

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.

Eligible subjects 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 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.

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 pregnancy test, they will be tested again at the study visit.

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 than 6 months).

Exclusion Criteria

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 \<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.

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 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.

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 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.

Not sure if you qualify? Submit your interest and a study coordinator will help determine your eligibility.

Frequently Asked Questions

Q:Is this study available in Aurora?

Yes, this clinical trial (NCT05937854) has an active research site in Aurora, CO that is currently enrolling participants.

Q:Is it safe to participate?

Clinical trials follow strict safety guidelines and ethical standards. This study has been reviewed and approved, and participants are closely monitored by medical professionals. You can withdraw at any time.

Q:Will I be compensated?

Many clinical trials offer compensation for your time and travel expenses. Specific compensation details will be discussed during the screening process. All study-related medical care is provided at no cost.

Q:Can I leave the trial if I change my mind?

Absolutely. Participation is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty.

Still have questions? Our study coordinators are here to help.

COPD Treatment Options in Aurora, CO

If you're searching for copd treatment options in Aurora, CO, this clinical trial (NCT05937854) may be an excellent opportunity. Clinical trials provide access to cutting-edge treatments that aren't yet available to the general public, often at no cost to participants.

Our Aurora research site is actively enrolling participants for this phase 2 clinical trial. You'll receive care from experienced copd specialists who are at the forefront of medical research. All study-related care, including examinations, treatments, and monitoring, is provided at no cost to qualified participants.

Looking for more options? Browse all copd clinical trials near you to find additional studies recruiting in your area.

COPD Clinical Trial in Aurora, CO

Expert Care in Aurora

IRB Approved

No-Cost Care

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