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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

Status
Active, not recruiting
Phases
Phase 2
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06969573
Enrollment
20
Registered
2025-05-14
Start date
2025-06-05
Completion date
2026-12-31
Last updated
2026-07-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

COPD (Chronic Obstructive Pulmonary Disease)

Keywords

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

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

Detailed description

The study consists of 6 visits (5 to the Clinical Sciences Building at the University of Alberta): Day 1: participants will provide informed consent, medical history and health screening (Physical activity readiness questionnaire \[PAR-Q+\], COPD assessment test \[CAT\], modified medical research council \[mMRC\], euro quality of life- 5 dimensions \[EQ-5D\]), be familiarized to the laboratory and experimental measurement protocols, conduct a pulmonary function test, and conduct an incremental CPET to determine peak oxygen consumption (V̇O2peak) on the cycle ergometer. Throughout exercise, non-invasive measurements of cardiac output (impedance cardiography), heart rate (electrocardiogram), expired gases (metabolic cart), and oxygen saturation (pulse oximetry) will be completed. A small blood sample will be collected via finger prick to measure hemoglobin (to correct DLCO - part of the pulmonary function test). Ratings of perceived breathing and leg discomfort (Borg scale), as well as dimensional descriptors of dyspnea scales will be recorded throughout the exercise test, and immediately upon exercise cessation. Days 2-4: participants will complete resting, seated, DLCO maneuvers as well as a constant workload (75% of the peak power output determined from the CPET) cycling exercise test until volitional fatigue (i.e., exhaustion) with or without inhaled Treprostinil (placebo, 36, or 78 mcg; via Tyvaso® Inhalation Solution). DLCO and its components will be evaluated by standardized multiple breath-hold technique. A small blood sample will be collected via finger prick to measure hemoglobin for the DLCO maneuvers prior to and following exercise. Throughout exercise, non-invasive measurements of cardiac output (impedance cardiography), heart rate (electrocardiogram), expired gases (metabolic cart), and oxygen saturation (pulse oximetry) will be completed. Additionally, ratings of perceived breathing and leg discomfort (Borg scale), as well as dimensional descriptors of dyspnea scales will be recorded throughout the exercise test, and immediately upon exercise cessation. The drug condition (placebo, 36, or 78 mcg) will be randomized (block randomization) by a member of our research team who is not involved in data analysis or collection. Day 5: participants will complete supine DLCO maneuvers (multiple breath-hold technique) as well as resting echocardiography (to measure pulmonary artery and cardiac function) with and without inhaled Treprostinil (placebo, 36, and 78 mcg). A small blood sample will be collected via finger prick to measure hemoglobin for the DLCO maneuvers. Day 6: participants will undergo a low contrast CT scan of their chest for quantification of pulmonary vascular volumes (i.e., blood vessel volume in the lungs). No drug intervention will be completed on Day 6.

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

Sponsors

University of Alberta
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)

Intervention model description

Randomized double-blind cross-over design

Eligibility

Sex/Gender
ALL
Age
50 Years to 85 Years
Healthy volunteers
No

Inclusion criteria

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

Exclusion criteria

* 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

Design outcomes

Primary

MeasureTime frameDescription
Exercise toleranceWithin 30-45 minutes post doseTime to symptom limitation/exhaustion during a constant work rate test.
Exertional dyspneaWithin 30-45 minutes post doseMaximal perceived breathing discomfort during exercise
Ventilatory efficiencyWithin 30-45 minutes post doseNadir value of the ratio between ventilation and the rate of CO2 production (Ve/VCO2 nadir)

Secondary

MeasureTime frameDescription
Lung diffusing capacityWithin 15-30 minutes post doseLung diffusing capacity (DLCO) will be measured using six-second, advanced DLCO techniques.
Pulmonary capillary blood volume (Vc)Within 15-30 minutes post dosePulmonary capillary blood volume (Vc) will be measured using six-second, advanced DLCO techniques.
Diffusing membrane Capacity (Dm)Within 15-30 minutes post doseDiffusing membrane capacity will be measured using six-second, advanced DLCO techniques.
Cardiac structure and functionWithin 15-30 minutes post doseechocardiography-derived right ventricular systolic pressure
Pulmonary vascular volumesDay 6Chest computed tomography (CT) scan

Countries

Canada

Contacts

PRINCIPAL_INVESTIGATORMichael Stickland

University of Alberta

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Jul 9, 2026