Using Sildenafil to Improve Exercise Capacity in Mild COPD

The Effect of Oral Sildenafil on Exercise Capacity, Dyspnea and Cardiopulmonary Function in Chronic Obstructive Pulmonary Disease (COPD)

This study is testing if the medication Sildenafil can help people with mild COPD exercise better and breathe easier.

Quick facts

• Phase: Phase 2
• Study type: Interventional
• Enrollment: 160 (estimated)
• Ages: 40 Years to 80 Years
• Sex: All
• Sponsor: University of Alberta (Academic / other)
• Locations: 1 site (Edmonton, Alberta)
• Trial ID: NCT05061368 on ClinicalTrials.gov

What this trial studies

This clinical trial investigates the effects of oral Sildenafil on exercise capacity, dyspnea, and cardiopulmonary function in patients with mild Chronic Obstructive Pulmonary Disease (COPD). The study aims to understand how pulmonary vascular dysfunction contributes to exercise intolerance in these patients. Participants will be given either Sildenafil or a placebo, and their responses will be measured through various pulmonary function tests and exercise assessments. The trial seeks to clarify the mechanisms behind exertional dyspnea in mild COPD and evaluate the potential therapeutic benefits of Sildenafil.

Who should consider this trial

Good fit: Ideal candidates for this study are individuals diagnosed with mild COPD who meet specific pulmonary function criteria.

Not a fit: Patients with moderate to severe COPD or those with pre-existing cardiac conditions may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could lead to improved treatment options for patients with mild COPD, enhancing their exercise capacity and quality of life.

How similar studies have performed: Previous studies have shown promising results using similar approaches to address pulmonary vascular dysfunction in COPD, indicating potential for success in this trial.

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.

Where this trial is running

Edmonton, Alberta

• Clinical Physiology Laboratory — Edmonton, Alberta, Canada (Recruiting)

Study contacts

• Principal investigator: Michael K Stickland, Ph.D. — University of Alberta
• Study coordinator: Desi Fuhr, MSc

Conditions Chronic Obstructive Pulmonary Disease; COPD; Sildenafil; Pulmonary Vascular Function; Pulmonary Vascular Pressure; DLCO; Pulmonary Capillary Blood Volume; Dyspnea