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New treatment option for Chronic Obstructive Pulmonary Disease
Official title Oral Sildenafil for Exercise Capacity, Dyspnea and Cardiopulmonary Function in COPD
ClinicalTrials.gov ID: NCT05061368
What this study is testing
What is Sildenafil Citrate?
Sildenafil Citrate is an investigational medicine, given as an once-daily pill taken by mouth, being studied as a potential treatment for chronic obstructive pulmonary disease.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- Chronic obstructive pulmonary disease (COPD) is a condition characterized by airway obstruction. Patients with COPD experience significant shortness of breath on exertion.
- Phase 2: a mid-size study of how well it works
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance. You may not know which one you got.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 40 to 80. Healthy volunteers may be eligible.
You may be able to join if
- Participants will have COPD as defined as:
- Post bronchodilator Forced Expiratory Volume in one second (FEV1) to Forced Vital Capacity (FVC) ratio (FEV1/FVC) below the lower limit of normal
- FEV1 \>30% of predicted (lower limit of GOLD severe COPD classification) COPD Free Controls will have:
- No diagnosis of COPD
- Post bronchodilator Forced Expiratory Volume in one second (FEV1) to Forced Vital Capacity (FVC) ratio (FEV1/FVC) above the lower limit of normal
You likely can't join if
- Absolute contraindication to exercise testing or an orthopedic condition that may limit exercise testing.
- Pre-existing cardiac conditions (heart failure, congenital heart defect, valvular disease) that may limit exercise testing
- A diagnosis of pulmonary hypertension preceding COPD
- Current phosphodiesterase type-5 inhibitor, nitrate, opioid, azole antifungal, macrolide antibiotic, protease inhibitor, alpha blocker, riociguat...
- Pregnancy or lactation.
- Women of childbearing potential must be willing to use an acceptable method of contraception to avoid pregnancy throughout the study. Acceptable...
See the full eligibility criteria
- Participants will have COPD as defined as:
- Post bronchodilator Forced Expiratory Volume in one second (FEV1) to Forced Vital Capacity (FVC) ratio (FEV1/FVC) below the lower limit of normal
- FEV1 \>30% of predicted (lower limit of GOLD severe COPD classification) COPD Free Controls will have:
- No diagnosis of COPD
- Post bronchodilator Forced Expiratory Volume in one second (FEV1) to Forced Vital Capacity (FVC) ratio (FEV1/FVC) above the lower limit of normal
- FEV1 \>80% of predicted
- Absolute contraindication to exercise testing or an orthopedic condition that may limit exercise testing.
- Pre-existing cardiac conditions (heart failure, congenital heart defect, valvular disease) that may limit exercise testing
- A diagnosis of pulmonary hypertension preceding COPD
- Current phosphodiesterase type-5 inhibitor, nitrate, opioid, azole antifungal, macrolide antibiotic, protease inhibitor, alpha blocker, riociguat, mifepristone or rifamycin use.
- Pregnancy or lactation.
- 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...
- Postmenopausal female participants must be amenorrheic for ≥12 months.
The study team makes the final eligibility decision.
Where it's taking place
- Edmonton, Alberta, Canada
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 40 years to 80 years. Healthy volunteers may be eligible. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Edmonton, Alberta, Canada. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.