COPD (Chronic Obstructive Pulmonary Disease)Phase 2NCT06969573
Inhaled Treprostinil for Dyspnea and Exercise Intolerance in Mild COPD
A Phase 2 study testing Treprostinil Inhalation Solution 36 mcg and Treprostinil Inhalation Solution 78 mcg in people with COPD (Chronic Obstructive Pulmonary Disease), run by University of Alberta at 1 site in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 50 to 85 years
- Conditions the study is for
- COPD (Chronic Obstructive Pulmonary Disease)
- What is being tested?
- Treprostinil Inhalation Solution 36 mcg and Treprostinil Inhalation Solution 78 mcg
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 20 participants
- Where
- 1 siteCanada
- Study dates
- 5 Jun 2025to 31 Dec 2026
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with mild COPD (defined as having a postbronchodilator FEV1/FVC ratio <0.70 and FEV1 ≥ 80% predicted
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Impact of Inhaled Treprostinil on Dyspnea and Exercise Intolerance in Mild COPD; a Pilot and Feasibility 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
Read the 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.
- Being tested
- Placebo, Treprostinil Inhalation Solution 36 mcg, Treprostinil Inhalation Solution 78 mcg
- Keywords
- dyspnea, exercise tolerance, exercise capacity, inhaled Treprostinil, Prostacyclin, pulmonary vascular
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive, Dyspnea
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PlaceboDrug
Participants will breathe placebo (room air) from the Tyvaso Inhalation System Ultrasonic nebulizer
Treprostinil Inhalation Solution 36 mcgCombination product
Participants will breathe either 36 mcg of Treprostinil from the Tyvaso Inhalation System Ultrasonic nebulizer
Treprostinil Inhalation Solution 78 mcgCombination product
Participants will breathe either 78 mcg of Treprostinil from the Tyvaso Inhalation System Ultrasonic nebulizer
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | Participants will inhale placebo (room air) from the Tyvaso Inhalation System Ultrasonic nebulizer Receives: Drug: Placebo |
| Treprostinil 36 mcg | Experimental | Participants will inhale 36 mcg of Treprostinil from the Tyvaso Inhalation System Ultrasonic nebulizer Receives: 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 Receives: Combination Product: Treprostinil Inhalation Solution 78 mcg |
What is being measured
The primary outcome is the main question the study is designed to answer.
Exercise tolerance
Time to symptom limitation/exhaustion during a constant work rate test.
Measured: Within 30-45 minutes post dose
Exertional dyspnea
Maximal perceived breathing discomfort during exercise
Measured: Within 30-45 minutes post dose
Ventilatory efficiency
Nadir value of the ratio between ventilation and the rate of CO2 production (Ve/VCO2 nadir)
Measured: Within 30-45 minutes post dose
Secondary outcomes (5)
Lung diffusing capacity
Lung diffusing capacity (DLCO) will be measured using six-second, advanced DLCO techniques.
Measured: Within 15-30 minutes post dose
Pulmonary capillary blood volume (Vc)
Pulmonary capillary blood volume (Vc) will be measured using six-second, advanced DLCO techniques.
Measured: Within 15-30 minutes post dose
Diffusing membrane Capacity (Dm)
Diffusing membrane capacity will be measured using six-second, advanced DLCO techniques.
Measured: Within 15-30 minutes post dose
Cardiac structure and function
echocardiography-derived right ventricular systolic pressure
Measured: Within 15-30 minutes post dose
Pulmonary vascular volumes
Chest computed tomography (CT) scan
Measured: Day 6
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 May 2025
- Study start5 Jun 2025
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for COPD (Chronic Obstructive Pulmonary Disease)Studies of the same condition, open and under way.
- More trials run by University of AlbertaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- Randomized double-blind cross-over design
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Alberta
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Michael Stickland, Principal investigator, University of Alberta
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06969573
- Sponsor's protocol ID
- Pro00137313
- Status last verified
- Nov 2026
- First submitted
- 16 Apr 2025
- Last updated
- 5 Nov 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Impact of Inhaled Treprostinil on Dyspnea and Exercise Intolerance in Mild COPD; a Pilot and Feasibility Trial
- ClinicalTrials.gov ID
- NCT06969573
- Acronym / sponsor ID
- Pro00137313
- Keywords
- dyspnea, exercise tolerance, exercise capacity, inhaled Treprostinil, Prostacyclin, pulmonary vascular
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 20 participants (actual)
- Lead sponsor
- University of AlbertaUniversity, hospital or other
- Study start
- 5 Jun 2025 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 14 May 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 3
- Model description
- Randomized double-blind cross-over design
| Arm | Type | Receives |
|---|---|---|
| Placebo | Placebo comparator | Drug: PlaceboParticipants will inhale placebo (room air) from the Tyvaso Inhalation System Ultrasonic nebulizer |
| Treprostinil 36 mcg | Experimental | Combination Product: Treprostinil Inhalation Solution 36 mcgParticipants will inhale 36 mcg of Treprostinil from the Tyvaso Inhalation System Ultrasonic nebulizer |
| Treprostinil 78 mcg | Experimental | Combination Product: Treprostinil Inhalation Solution 78 mcgParticipants will inhale 78 mcg of Treprostinil from the Tyvaso Inhalation System Ultrasonic nebulizer |
Who may qualify
- Ages
- 50 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients with mild COPD (defined as having a postbronchodilator FEV1/FVC ratio <0.70 and FEV1 ≥ 80% predicted
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PlaceboParticipants will breathe placebo (room air) from the Tyvaso Inhalation System Ultrasonic nebulizer | Drug | Placebo |
| Treprostinil Inhalation Solution 36 mcgParticipants will breathe either 36 mcg of Treprostinil from the Tyvaso Inhalation System Ultrasonic nebulizer | Combination product | Treprostinil 36 mcg |
| Treprostinil Inhalation Solution 78 mcgParticipants will breathe either 78 mcg of Treprostinil from the Tyvaso Inhalation System Ultrasonic nebulizer | Combination product | Treprostinil 78 mcg |
Primary outcome
Exercise tolerance
Time frame: Within 30-45 minutes post dose
Time to symptom limitation/exhaustion during a constant work rate test.
Exertional dyspnea
Time frame: Within 30-45 minutes post dose
Maximal perceived breathing discomfort during exercise
Ventilatory efficiency
Time frame: Within 30-45 minutes post dose
Nadir value of the ratio between ventilation and the rate of CO2 production (Ve/VCO2 nadir)
5 secondary outcomes
Lung diffusing capacity
Time frame: Within 15-30 minutes post dose
Pulmonary capillary blood volume (Vc)
Time frame: Within 15-30 minutes post dose
Diffusing membrane Capacity (Dm)
Time frame: Within 15-30 minutes post dose
Cardiac structure and function
Time frame: Within 15-30 minutes post dose
Pulmonary vascular volumes
Time frame: Day 6
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Nov 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Michael Stickland principal investigator
University of Alberta
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Treprostinil Inhalation Solution 36 mcg and Treprostinil Inhalation Solution 78 mcg in people with COPD (Chronic Obstructive Pulmonary Disease), run by University of Alberta at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 5 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Exercise tolerance (time frame: Within 30-45 minutes post dose). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Nov 2026.