Inhaled Treprostinil for Mild COPD
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests an inhaled medication called Treprostinil to determine if it can help individuals with mild COPD (chronic obstructive pulmonary disease) breathe easier and improve exercise capacity. Participants will inhale either Treprostinil at varying doses or a placebo (a substance with no active drug) and undergo tests such as lung function assessments and heart ultrasounds. The goal is to determine if Treprostinil can significantly reduce breathlessness during physical activity. Individuals with mild COPD and consistent breathing difficulties may be suitable candidates for this trial. As a Phase 2 trial, this research focuses on evaluating the treatment's effectiveness in an initial, smaller group, allowing participants to contribute to important findings.
Do I have to stop taking my current medications for the trial?
The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.
Is there any evidence suggesting that this trial's treatments are likely to be safe?
Research has shown that inhaled Treprostinil has been tested in individuals with conditions like pulmonary hypertension, which involves high blood pressure in the lungs. Some studies have found it to be generally well-tolerated, though possible side effects exist. Treprostinil, for instance, might cause acute bronchospasm, a sudden tightening of the muscles in the lungs, which could concern those with asthma or chronic obstructive pulmonary disease (COPD).
In earlier studies, patients experienced various side effects, but most were not severe. The current study is in an early phase, so much remains to be learned about the treatment's safety for individuals with mild COPD. Participants should understand both the potential benefits and risks before joining the trial.12345Why are researchers excited about this trial's treatments?
Unlike the standard treatments for COPD, which often include bronchodilators and corticosteroids, Treprostinil offers a new approach by directly targeting blood vessels in the lungs to improve blood flow. This treatment is administered through inhalation using the Tyvaso Inhalation System, which could potentially enhance its effectiveness by delivering the medication directly to the lungs. Researchers are particularly excited because Treprostinil could provide benefits for individuals with mild COPD, a group that often has fewer targeted treatment options. The inhalation method might also reduce systemic side effects compared to some current therapies, offering a safer alternative for patients.
What evidence suggests that inhaled Treprostinil might be an effective treatment for mild COPD?
Research has shown that inhaled Treprostinil can improve exercise capacity in people with lung diseases. In studies involving patients with pulmonary hypertension (high blood pressure in the lungs), those using Treprostinil walked farther after just six weeks, suggesting improved lung function. In this trial, participants will receive either Treprostinil at doses of 36 mcg or 78 mcg, or a placebo, to test its effects on shortness of breath and exercise ability in individuals with mild chronic obstructive pulmonary disease (COPD). Additionally, Treprostinil may enhance oxygen and blood flow through the lungs.36789
Who Is on the Research Team?
Michael Stickland
Principal Investigator
University of Alberta
Are You a Good Fit for This Trial?
This trial is for people with mild chronic obstructive pulmonary disease (COPD) who experience shortness of breath and struggle with exercise. Participants will undergo lung function tests, heart ultrasounds, CT scans of their lungs, and must be able to visit the lab five times plus one additional CT imaging clinic visit.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants undergo various tests and receive inhaled Treprostinil or placebo during exercise tests
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- Treprostinil
Find a Clinic Near You
Who Is Running the Clinical Trial?
University of Alberta
Lead Sponsor