Inhaled Treprostinil for Dyspnea and Exercise Intolerance in Mild COPD

NCT06969573 | Active Not Recruiting Phase 2 DMC FDA Drug FDA Device

• 1 other identifier: Pro00137313
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief 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

Conditions

COPD (Chronic Obstructive Pulmonary Disease)

Keywords

dyspnea; exercise tolerance; exercise capacity; inhaled Treprostinil; Prostacyclin; pulmonary vascular

Outcome Measures

Primary Outcomes (3)

• Exercise tolerance

  Time to symptom limitation/exhaustion during a constant work rate test.

  Within 30-45 minutes post dose

• Exertional dyspnea

  Maximal perceived breathing discomfort during exercise

  Within 30-45 minutes post dose

• Ventilatory efficiency

  Nadir value of the ratio between ventilation and the rate of CO2 production (Ve/VCO2 nadir)

  Within 30-45 minutes post dose

Secondary Outcomes (5)

• Lung diffusing capacity

  Within 15-30 minutes post dose

• Pulmonary capillary blood volume (Vc)

  Within 15-30 minutes post dose

• Diffusing membrane Capacity (Dm)

  Within 15-30 minutes post dose

• Cardiac structure and function

  Within 15-30 minutes post dose

• Pulmonary vascular volumes

  Day 6

Study Arms (3)

Placebo

PLACEBO COMPARATOR

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

Drug: Placebo

Treprostinil 36 mcg

EXPERIMENTAL

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

Combination Product: Treprostinil Inhalation Solution 36 mcg

Treprostinil 78 mcg

EXPERIMENTAL

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

Combination Product: Treprostinil Inhalation Solution 78 mcg

Interventions

Placebo DRUG

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

Placebo

Treprostinil Inhalation Solution 36 mcg COMBINATION_PRODUCT

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

Treprostinil 36 mcg

Treprostinil Inhalation Solution 78 mcg COMBINATION_PRODUCT

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

Treprostinil 78 mcg

Eligibility Criteria

• Age: 50 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Alberta: lead

Study Sites (1)

Clinical Physiology Laboratory

Edmonton, Alberta, T6G2R3, Canada

Location

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive; Dyspnea

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Respiration Disorders; Signs and Symptoms, Respiratory; Signs and Symptoms

Study Officials

• Michael Stickland

  University of Alberta

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Randomized double-blind cross-over design

Study Record Dates

• First Submitted: April 16, 2025
• First Posted: May 14, 2025
• Study Start: June 5, 2025
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: June 4, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)