Using Sildenafil to Improve Exercise Capacity in Mild COPD

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• Clinical Physiology Laboratory
  Edmonton, Alberta, Canada Recruiting

Study contacts

• Principal investigator: Michael K Stickland, Ph.D. — University of Alberta
• Study coordinator: Desi Fuhr, MSc
• Email: fuhr@ualberta.ca
• Phone: 7804921121

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.