RecruitingPhase 2NCT06969573

Inhaled Treprostinil for Dyspnea and Exercise Intolerance in Mild COPD

The Impact of Inhaled Treprostinil on Dyspnea and Exercise Intolerance in Mild COPD; a Pilot and Feasibility Trial


Sponsor

University of Alberta

Enrollment

20 participants

Start Date

Jun 5, 2025

Study Type

INTERVENTIONAL

Conditions

Summary

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


Eligibility

Min Age: 50 YearsMax Age: 85 Years

Inclusion Criteria1

  • Patients with mild COPD (defined as having a postbronchodilator FEV1/FVC ratio \<0.70 and FEV1 ≥ 80% predicted

Exclusion Criteria5

  • Pre-existing heart failure and pulmonary artery hypertension.
  • Known thrombocytopenia.
  • Resting blood pressure of \<90mmHg systolic and \<50 mmHg diastolic.
  • Known sensitivity to prostanoids
  • Severe hepatic insufficiency

Interventions

DRUGPlacebo

Participants will breathe placebo (room air) from the Tyvaso Inhalation System Ultrasonic nebulizer

COMBINATION_PRODUCTTreprostinil Inhalation Solution 36 mcg

Participants will breathe either 36 mcg of Treprostinil from the Tyvaso Inhalation System Ultrasonic nebulizer

COMBINATION_PRODUCTTreprostinil Inhalation Solution 78 mcg

Participants will breathe either 78 mcg of Treprostinil from the Tyvaso Inhalation System Ultrasonic nebulizer


Locations(1)

Clinical Physiology Laboratory

Edmonton, Alberta, Canada

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NCT06969573


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