Chronic Obstructive Pulmonary Disease study: Sildenafil Citrate
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?
An investigational oral medication being studied for improving exercise tolerance in patients with mild Chronic Obstructive Pulmonary Disease (COPD). It is designed to inhibit phosphodiesterase type 5, thereby potentiating nitric oxide mediated vasodilation.
Also referred to as Sildenafil.
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
- The study wants to find out if sildenafil can improve exercise tolerance and reduce shortness of breath in people with mild COPD.
- Who it's for
- Adults with mild chronic obstructive pulmonary disease (COPD).
- What's involved
- Participants will take oral sildenafil and have exercise tests and breathing measurements done during the study.
- Time commitment
- The study lasts several weeks and includes multiple clinic visits for medication and testing.
- 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
- Post bronchodilator Forced Expiratory Volume in one second (FEV1) to Forced Vital Capacity (FVC) ratio (FEV1/FVC) below the lower limit of normal
- 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
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.
See the full eligibility criteria
- Post bronchodilator Forced Expiratory Volume in one second (FEV1) to Forced Vital Capacity (FVC) ratio (FEV1/FVC) below the lower limit of normal
- 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.
- Postmenopausal female participants must be amenorrheic for ≥12 months.
The study team makes the final eligibility decision.
Where it is enrolling
- 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, but 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?
This study is enrolling now at Edmonton, Alberta, Canada. Enter your location above to see the nearest enrolling site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool that is independent of the study sponsor. Details come from ClinicalTrials.gov. The study team decides eligibility, and your own doctor gives medical advice.