Oral Sildenafil for Exercise Capacity, Dyspnea and Cardiopulmonary Function in COPD

Launched by UNIVERSITY OF ALBERTA · Sep 20, 2021

Keywords

ClinConnect Summary

This clinical trial is studying the effects of a medication called sildenafil on patients with mild Chronic Obstructive Pulmonary Disease (COPD). COPD is a lung condition that makes it hard to breathe, especially during physical activities. In this study, researchers want to see if sildenafil can help improve exercise capacity and reduce feelings of shortness of breath in people with mild COPD. They have found that problems with blood flow in the lungs might contribute to the difficulties these patients experience when they exercise.

To participate in the trial, individuals must have a confirmed diagnosis of mild COPD and meet certain health criteria, such as having a specific lung function measurement. The trial is open to adults of all genders, ages 18 to 80. Participants will undergo exercise tests and may receive sildenafil or a placebo (a non-active pill) to compare the results. It’s important to note that certain medical conditions or medications may prevent someone from participating. Overall, this trial aims to gather more information about how sildenafil might help improve the quality of life for those living with mild COPD.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• Participants will have COPD as defined as:
• • 1. Post bronchodilator Forced Expiratory Volume in one second (FEV1) to Forced Vital Capacity (FVC) ratio (FEV1/FVC) below the lower limit of normal
• • 2. FEV1 \>30% of predicted (lower limit of GOLD severe COPD classification)
• COPD Free Controls will have:
• • 1. No diagnosis of COPD
• • 2. Post bronchodilator Forced Expiratory Volume in one second (FEV1) to Forced Vital Capacity (FVC) ratio (FEV1/FVC) above the lower limit of normal
• • 3. FEV1 \>80% of predicted
• Exclusion Criteria:
• • 1. Absolute contraindication to exercise testing or an orthopedic condition that may limit exercise testing.
• • 2. Pre-existing cardiac conditions (heart failure, congenital heart defect, valvular disease) that may limit exercise testing
• • 3. A diagnosis of pulmonary hypertension preceding COPD
• • 4. Current phosphodiesterase type-5 inhibitor, nitrate, opioid, azole antifungal, macrolide antibiotic, protease inhibitor, alpha blocker, riociguat, mifepristone or rifamycin use.
• • 5. Pregnancy or lactation.
• • 6. Women of childbearing potential must be willing to use an acceptable method of contraception to avoid pregnancy throughout the study. Acceptable methods of contraception include tubal ligation, oral contraceptive, barrier methods (intra-uterine device, diaphragm, female condom, male condom). Abstinence is an acceptable form of contraception, only insofar as patients agree to use another acceptable method of birth control, preferably a barrier method, if they become sexually active.
• • 7. Postmenopausal female participants must be amenorrheic for ≥12 months.