RecruitingPHASE2INTERVENTIONAL

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

This study is investigating if a medication, sildenafil, can improve breathing and exercise ability in people with a mild form of Chronic Obstructive Pulmonary Disease (COPD). Even with mild COPD, some people struggle with shortness of breath during everyday activities, and the reasons for this aren't fully clear. Researchers believe issues with blood flow in the lungs might play a role. We've seen good results with a similar medicine before, so we're testing sildenafil to see if it can help open up blood vessels in the lungs, making it easier to breathe and exercise. This could lead to better treatments for symptoms often experienced by those with mild COPD.

At a glance

Status

Recruiting

Phase

PHASE2

Sponsor

University of Alberta

Enrolment target

160

Start

01 Mar 2022

Estimated completion

01 May 2027

Chronic Obstructive Pulmonary Disease

What is this study about?

Chronic Obstructive Pulmonary Disease, or COPD, makes it hard to breathe because of narrowed airways. While we understand a lot about severe COPD, it's less clear why some people with *mild* COPD feel very breathless even during light activity. This shortness of breath can make daily life difficult and reduce overall well-being. Researchers think this might be linked to problems with how blood flows through the tiny blood vessels in the lungs.

Imagine your lungs like a sponge that takes in air (ventilation) and has a network of tiny tubes (blood vessels) through which blood flows (perfusion). For oxygen to get into your blood efficiently, the air and blood supply need to be well-matched. In mild COPD, this match might be off, or some parts of the lung might get air but not enough blood, leading to the feeling of breathlessness.

Previous work using a different medicine, inhaled nitric oxide, showed promise in helping people with mild COPD breathe easier and exercise better. This suggests that improving blood flow in the lungs could be a key to reducing these symptoms. This study aims to test if sildenafil, a tablet medication that also helps open up blood vessels, can bring similar benefits to people with mild COPD. By improving lung blood flow, we hope to reduce shortness of breath and improve how well people can exercise.

Key takeaways

This study investigates a new treatment for shortness of breath in mild COPD.
It tests sildenafil, a medicine that helps open blood vessels, to improve breathing and exercise.
The study aims to understand why people with mild COPD get so breathless.
Participants will receive either sildenafil or a dummy pill (placebo).
It involves breathing and exercise tests at a clinic.

Who may be eligible?

To be part of this study, you would need to have mild COPD. This means your breathing tests show specific signs of COPD, but your lung function isn't severely affected. We also need healthy volunteers to compare results with.

There are also some reasons why you might not be able to join. For example, if you have certain heart conditions, or if you're taking specific medications that might interfere with the study drug. We also wouldn't be able to include pregnant or breastfeeding women, or those who can't use effective birth control during the study.

Finally, you'd need to be between 40 and 80 years old, and able to do exercise tests. All potential participants will have their health carefully checked to make sure it's safe for them to take part.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

Do I have mild COPD, confirmed by a doctor?
Am I between 40 and 80 years old?
Do I have any heart conditions or other serious illnesses?
Am I currently pregnant, breastfeeding, or planning to become pregnant?
Am I able to safely do exercise tests?
Am I taking any medications that might interact with sildenafil?

Answer every question to see your result.

What does participation involve?

If you decide to take part, you'll be given either the study drug, sildenafil, or a placebo (a dummy pill with no active medicine). You won't know which one you're taking. You'll have several visits to the study clinic where you'll undergo various tests, including breathing tests and exercise tests to see how your lungs and heart respond. During these tests, your breathing and other body functions will be closely monitored. There will also be some blood tests. The medical team will explain everything in detail. The total duration of your participation in the study will be explained to you, including how many visits are needed and how long each visit might take. More details will be given in the informed consent form if you're interested.

Potential risks and benefits

Taking part in this study could potentially help us understand more about how to treat shortness of breath in mild COPD, which could eventually benefit many people. However, there's no guarantee that you personally will benefit from taking the study drug. Like all medications, sildenafil can have side effects, which will be fully explained to you by the study team. Some of the tests, especially exercise tests, might be tiring. You are free to withdraw from the study at any time, for any reason, without it affecting your medical care.

Locations (1)

Clinical Physiology Laboratory
Verified postcode
Edmonton, Canada· Recruiting

Common questions

What is mild COPD?

Mild COPD means you have some airway narrowing in your lungs, but it's not as severe as moderate or severe COPD. You might still feel breathless during activity.

What is sildenafil?

Sildenafil is a medicine that helps to relax and widen blood vessels, including those in the lungs. It's used for various conditions, and in this study, we're seeing if it helps with blood flow in the lungs of people with COPD.

What is a placebo?

A placebo is a 'dummy' pill that looks just like the study drug but contains no active medicine. It helps us compare the effects of the actual drug against no treatment.

Will I know if I'm taking the real drug or the placebo?

No, this is a 'blinded' study, meaning neither you nor the study team will know if you're taking sildenafil or the placebo until after the study is over. This helps ensure fair results.

What kind of tests will I have?

You'll have tests to check your breathing and how well you can exercise. This might involve walking on a treadmill or cycling while your heart rate, breathing, and oxygen levels are monitored carefully.

How to find out more

Desi Fuhr, MSc

fuhr@ualberta.ca 7804921121 Official trial record

Always speak to your GP or specialist before deciding to take part in a study.