Inhaled Treprostinil for Mild COPD
DF
AW
Overseen ByAndrew W D'Souza, PhD
Age: 18+
Sex: Any
Trial Phase: Phase 2
Sponsor: University of Alberta
Prior Safety DataThis treatment has passed at least one previous human trial
Trial Summary
What is the purpose of this trial?
The goal of this clinical trial is to evaluate the impact of inhaled Treprostinil on breathlessness and low exercise capacity in patients living with mild chronic obstructive pulmonary disease. Participants will be asked to: * Perform lung function and exercise tests * Have ultrasound of their heart * Have CT images of their lungs * Visit the lab on 5 different occasions (plus one visit to the CT imaging clinic) The researchers will compare the effectiveness and feasibility of inhaled Treprostinil to improve breathlessness upon exertion and exercise capacity
Research Team
MS
Michael Stickland
Principal Investigator
University of Alberta
Eligibility Criteria
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
I have mild COPD.
Exclusion Criteria
Resting blood pressure of <90mmHg systolic and <50 mmHg diastolic
Known sensitivity to prostanoids
Known thrombocytopenia
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Treatment Details
Interventions
- Treprostinil
Trial Overview The study is testing inhaled Treprostinil at two different doses (36 mcg and 78 mcg) against a placebo to see if it can help reduce breathlessness and improve the ability to exercise in those with mild COPD. The effectiveness of this treatment will be measured through various physical assessments.
Participant Groups
3Treatment groups
Experimental Treatment
Placebo Group
Group I: Treprostinil 78 mcgExperimental Treatment1 Intervention
Participants will inhale 78 mcg of Treprostinil from the Tyvaso Inhalation System Ultrasonic nebulizer
Group II: Treprostinil 36 mcgExperimental Treatment1 Intervention
Participants will inhale 36 mcg of Treprostinil from the Tyvaso Inhalation System Ultrasonic nebulizer
Group III: PlaceboPlacebo Group1 Intervention
Participants will inhale placebo (room air) from the Tyvaso Inhalation System Ultrasonic nebulizer
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Who Is Running the Clinical Trial?
University of Alberta
Lead Sponsor
Trials
957
Recruited
437,000+
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