COPD (Chronic Obstructive Pulmonary Disease)Phase 2TyvasoNCT07037836
Inhaled Treprostinil (Tyvaso Nebulizer) For COPD Patients With Hypoxemia
A Phase 2 study testing Inhaled Treprostinil (Tyvaso Nebulizer) in people with COPD (Chronic Obstructive Pulmonary Disease) and Hypoxemia, run by Bastiaan Driehuys at 1 site in United States.
Trial summary
The goal of this clinical trial is to evaluate whether inhaled Treprostinil (Tyvaso) can improve oxygen delivery and blood flow in the lungs in adults (age ≥40) with chronic obstructive pulmonary disease (COPD) and hypoxemia who have less severe reduction in lung blood volume (diffusing capacity of the lungs for… Read more about this study
- Who is it for?
- Ages 40 years and older
- Conditions the study is for
- COPD (Chronic Obstructive Pulmonary Disease), Hypoxemia
- What is being tested?
- Inhaled Treprostinil (Tyvaso Nebulizer)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteUnited States
- Study dates
- 29 Sep 2025to 1 Jul 2027
- 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 40 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Outpatients of either gender, age ≥ 40.
- Clinical evidence of chronic bronchitis (a productive cough lasting more than 3 months within a 2-year period).
- Current or former cigarette smokers with a smoking history of 20 or more pack-years.
- Clinical diagnosis of chronic obstructive pulmonary disease (COPD) confirmed by spirometry demonstrating forced expiratory volume in 1 second (FEV1) to forced vital capacity (FVC) ratio < 0.70, pre-bronchodilator FEV1 ≥ 30% predicted, and diffusing capacity of the lungs for carbon monoxide (DLCO) ≥ 45% predicted.
- On stable maintenance COPD medications including inhaled corticosteroids (ICS), long-acting beta agonists (LABA), long-acting muscarinic antagonists (LAMA), combination inhalers, azithromycin, or roflumilast (with no changes over the past 3 months).
- Patients with hypoxemia, evidenced by the use of supplemental oxygen at rest or during exercise (≤ 4 liters/minute).
- Willing and able to give informed consent and adhere to visit and protocol schedules (consent must be obtained prior to any study procedures).
- Women of childbearing potential must have a negative serum pregnancy test, confirmed prior to participation in this investigational protocol.
Who cannot join
- Upper respiratory tract infection within 6 weeks (participants may be rescreened after this period).
- History of lung resection surgery or pleural decortication.
- Previous history of pneumothorax.
- Imaging evidence of interstitial lung disease, occupational lung disease, or chronic infectious lung disease.
- History of asthma.
- History of exposure to occupational or environmental hazards known to cause lung disease.
Show all 16Show fewer
- Positive pregnancy test for women of childbearing potential.
- Major chronic illness that, in the judgment of the study physician, would interfere with participation in the study.
- For Magnetic Resonance Imaging (MRI):
- Contraindications to MRI based on screening questionnaire responses.
- Participant is pregnant or lactating.
- Respiratory illness of bacterial or viral etiology within 6 weeks prior to MRI.
- Known cardiac arrhythmia.
- Participant does not fit into the hyperpolarized xenon-129 (^129Xe) vest coil used for MRI.
- Participant cannot hold their breath for 10 seconds.
- Participant is unlikely to comply with instructions during imaging.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Duke Asthma Allergy and Airway Center
Durham, North Carolina, 27705
Savannah Barbieri, 919613740, savannah.barbieri@duke.edu
Jessica Shier, jessica.shier@duke.edu
About this study
The goal of this clinical trial is to evaluate whether inhaled Treprostinil (Tyvaso) can improve oxygen delivery and blood flow in the lungs in adults (age ≥40) with chronic obstructive pulmonary disease (COPD) and hypoxemia who have less severe reduction in lung blood volume (diffusing capacity of the lungs for carbon monoxide [DLCO] ≥45%).
The main questions it aims to answer are:
Read more
- Does inhaled Treprostinil increase pulmonary capillary blood volume in ventilated lung regions, as measured by hyperpolarized xenon-129 magnetic resonance imaging (HP129Xe MRI)?
- Does inhaled Treprostinil improve oxygen delivery (measured as red blood cell [RBC] chemical shift) and maintain or only slightly change pulmonary vascular resistance (measured by RBC oscillation amplitude)?
- Can pre-treatment MRI parameters (RBC transfer and RBC oscillation amplitude) predict who will respond to inhaled Treprostinil?
Participants will:
- Use the Tyvaso nebulizer (inhaled Treprostinil) 4 times daily for 4 weeks, starting at 3 breaths per session and increasing to a maximum of 6 breaths per session as tolerated.
- Undergo HP129Xe MRI before and after treatment to assess regional lung function and oxygen exchange.
- Complete pulmonary function tests (PFTs), 6-minute walk tests (6MWT), and echocardiograms at the beginning and end of the study.
- Be monitored for adverse events, with a phone check-in midway through and after the treatment period.
Read the detailed description
This is a single-arm, proof-of-concept study evaluating the effects of inhaled Treprostinil (Tyvaso nebulizer) on regional gas exchange and capillary blood oxygenation in patients with chronic obstructive pulmonary disease (COPD) and hypoxemia. The study will enroll 10 outpatient subjects aged ≥40 with a chronic bronchitis phenotype, confirmed COPD diagnosis, and a diffusing capacity of the lungs for carbon monoxide (DLCO) ≥45% predicted. All participants will receive inhaled Treprostinil via a 4-week dose titration protocol (starting at 3 breaths four times daily and increasing to 6 breaths as tolerated).
The primary objectives are to "determine the effects of inhaled Treprostinil on regional gas exchange and capillary blood oxygenation as measured by hyperpolarized xenon-129 magnetic resonance imaging (HP129Xe MRI), including ventilation defect percentage (VDP), membrane defect percentage, red blood cell (RBC) transfer defect percentage and normalized RBC oscillation amplitude and RBC frequency shift," and to "determine whether pre-treatment VDP, membrane defect percentage, RBC transfer defect percentage, RBC chemical shift and normalized RBC oscillation amplitude predict a positive response to inhaled Treprostinil."
Assessments will include HP129Xe MRI, spirometry with DLCO, 6-minute walk testing (6MWT), and echocardiography at baseline and after 4 weeks. Data will be analyzed for changes in regional lung function and oxygenation. Safety monitoring will focus on known adverse effects of inhaled Treprostinil including "cough, headache, hypotension, oropharyngeal pain, throat irritation and nausea," and will address more serious risks observed in the PERFECT trial (COPD exacerbation, respiratory failure, myocardial infarction, and death). By selecting subjects with DLCO ≥45% predicted and using a shorter 4-week treatment duration with titrated dosing, the study aims to mitigate these risks.
- Being tested
- Inhaled Treprostinil (Tyvaso Nebulizer)
- Keywords
- Tyvaso, COPD, Hypoxemia
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive, Hypoxia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Inhaled Treprostinil (Tyvaso Nebulizer)Drug
Participants will receive inhaled Treprostinil (Tyvaso nebulizer), 6 µg per breath, administered four times daily for 4 weeks. The starting dose will be 3 breaths per session. The dose will increase by 1 breath per session each week, as tolerated, to a target of 6 breaths per session by week 4. If adverse effects occur, participants will remain at the highest tolerated dose. The drug will be administered using the Tyvaso inhalation system provided by United Therapeutics. No changes to baseline COPD maintenance medications are allowed during the treatment period. Participants will be monitored for safety throughout the study.
| Study group | Role | What they receive |
|---|---|---|
| Inhaled Treprostinil in COPD Patients With Hypoxemia and Preserved DLCO | Experimental | Not described Receives: Drug: Inhaled Treprostinil (Tyvaso Nebulizer) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Ventilation Defect Percentage (VDP) on HP129XeMRI
Defined as the region with ventilation signals < mean - 2SD, measured by HP129XeMRI and expressed as a percentage of total lung volume.
Measured: Baseline and 4 weeks post-Tyvaso
Membrane Defect Percentage on HP129XeMRI
Defined as the region with membrane signals < mean - 2SD, measured by HP129XeMRI and expressed as a percentage of total lung volume.
Measured: Baseline and 4 weeks post-Tyvaso
Low Membrane Region Percentage on HP129XeMRI
Defined as the region with membrane signals between 1SD and 2SD below the mean, measured by HP129XeMRI and expressed as a percentage of total lung volume.
Measured: Baseline and 4 weeks post-Tyvaso
RBC Transfer Defect Percentage on HP129XeMRI
Defined as the region with RBC transfer signals < mean - 2SD, measured by HP129XeMRI and expressed as a percentage of total lung volume.
Measured: Baseline and 4 weeks post-Tyvaso
Low RBC Transfer Region Percentage on HP129XeMRI
Defined as the region with RBC transfer signals between 1SD and 2SD below the mean, measured by HP129XeMRI and expressed as a percentage of total lung volume.
Measured: Baseline and 4 weeks post-Tyvaso
RBC Oscillation Amplitude Normalized for RBC Transfer Defect
Measured using HP129XeMRI spectroscopy as a surrogate for pulmonary vascular resistance, normalized to RBC transfer signal intensity.
Measured: Baseline and 4 weeks post-Tyvaso
RBC Chemical Shift on HP129XeMRI Spectroscopy
Frequency shift in RBC signal reflecting capillary blood oxygenation, measured using HP129XeMRI spectroscopy.
Measured: Baseline and 4 weeks post-Tyvaso
Secondary outcomes (11)
Nadir SpO₂ During 6MWT
Lowest oxygen saturation (SpO₂) recorded during the 6-minute walk test, measured by pulse oximetry. The test is performed on room air unless SpO₂ drops below 89%, at which point supplemental oxygen is administered to maintain SpO₂ ≥89%.
Measured: Baseline and 4 weeks post-Tyvaso treatment
Supplemental Oxygen Flow During 6MWT
Oxygen flow rate in liters per minute required to maintain SpO₂ ≥89% during the 6-minute walk test if room air is insufficient.
Measured: Baseline and 4 weeks post-Tyvaso treatment
6-Minute Walk Distance (6MWD)
Total distance walked in meters during the 6-minute walk test, following ATS guidelines.
Measured: Baseline and 4 weeks post-Tyvaso treatment
Dyspnea Score During 6MWT
Subjective rating of dyspnea severity on a 1-10 scale reported by participants at the end of the 6-minute walk test.
Measured: Baseline and 4 weeks post-Tyvaso treatment
Peak Heart Rate (% Predicted) During 6MWT
Highest heart rate achieved during the 6-minute walk test, expressed as a percentage of predicted maximum heart rate.
Measured: Baseline and 4 weeks post-Tyvaso treatment
Forced Expiratory Volume in 1 Second (FEV1) - Absolute and % Predicted
EV1 measured in liters and as a percentage of predicted value, assessed by spirometry.
Measured: Baseline and 4 weeks post-Tyvaso treatment
Forced Vital Capacity (FVC) - Absolute and % Predicted
FVC measured in liters and as a percentage of predicted value, assessed by spirometry
Measured: Baseline and 4 weeks post-Tyvaso treatment
Total Lung Capacity (TLC) - Absolute and % Predicted
TLC measured in liters and as a percentage of predicted value, assessed by lung volume testing.
Measured: Baseline and 4 weeks post-Tyvaso treatment
Residual Volume (RV) - Absolute and % Predicted
RV measured in liters and as a percentage of predicted value, assessed by lung volume testing.
Measured: Baseline and 4 weeks post-Tyvaso treatment
Diffusing Capacity for Carbon Monoxide (DLCO) - Absolute and % Predicted
DLCO measured in mL/min/mmHg and as a percentage of predicted value, assessed by single-breath method.
Measured: Baseline and 4 weeks post-Tyvaso treatment
Carbon Monoxide Transfer Coefficient (KCO) - Absolute and % Predicted
KCO measured in mL CO/min/mmHg/L and as a percentage of predicted value, derived from DLCO and alveolar volume.
Measured: Baseline and 4 weeks post-Tyvaso treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jun 2025
- Study start29 Sep 2025
- Primary completion1 Jul 2027 (estimated)
- Study completion1 Jul 2027 (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.
- 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Bastiaan Driehuys
- Sponsor type
- University, hospital or other
- Collaborators
- United Therapeutics
- Responsible party
- Sponsor-investigator, Bastiaan Driehuys, Duke University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07037836
- Sponsor's protocol ID
- PRO00118083
- Acronym
- Tyvaso
- Status last verified
- Aug 2026
- First submitted
- 9 May 2025
- Last updated
- 27 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data (IPD) will not be shared for this study. The consent form limits future data use to internal research on lung disease and COPD and does not authorize sharing of de-identified IPD with external investigators. Therefore, data cannot be made available to other researchers outside of the study team.
Study at a glance
From the registry record, last updated by the sponsor on 27 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Inhaled Treprostinil (Tyvaso Nebulizer) For COPD Patients With Hypoxemia
- ClinicalTrials.gov ID
- NCT07037836
- Acronym / sponsor ID
- Tyvaso / PRO00118083
- Keywords
- Tyvaso, COPD, Hypoxemia
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- Bastiaan DriehuysUniversity, hospital or other
- Collaborators
- United Therapeutics
- Study start
- 29 Sep 2025 (actual)
- Primary completion
- 1 Jul 2027 (estimated)
- Study completion
- 1 Jul 2027 (estimated)
- First posted
- 26 Jun 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 whether inhaled Treprostinil (Tyvaso) can improve oxygen delivery and blood flow in the lungs in adults (age ≥40) with chronic obstructive pulmonary disease (COPD) and hypoxemia who have less severe reduction in lung blood volume (diffusing capacity of the lungs for carbon monoxide [DLCO] ≥45%).
The main questions it aims to answer are:
- Does inhaled Treprostinil increase pulmonary capillary blood volume in ventilated lung regions, as measured by hyperpolarized xenon-129 magnetic resonance imaging (HP129Xe MRI)?
- Does inhaled Treprostinil improve oxygen delivery (measured as red blood cell [RBC] chemical shift) and maintain or only slightly change pulmonary vascular resistance (measured by RBC oscillation amplitude)?
- Can pre-treatment MRI parameters (RBC transfer and RBC oscillation amplitude) predict who will respond to inhaled Treprostinil?
Participants will:
- Use the Tyvaso nebulizer (inhaled Treprostinil) 4 times daily for 4 weeks, starting at 3 breaths per session and increasing to a maximum of 6 breaths per session as tolerated.
- Undergo HP129Xe MRI before and after treatment to assess regional lung function and oxygen exchange.
- Complete pulmonary function tests (PFTs), 6-minute walk tests (6MWT), and echocardiograms at the beginning and end of the study.
- Be monitored for adverse events, with a phone check-in midway through and after the treatment period.
Detailed description
This is a single-arm, proof-of-concept study evaluating the effects of inhaled Treprostinil (Tyvaso nebulizer) on regional gas exchange and capillary blood oxygenation in patients with chronic obstructive pulmonary disease (COPD) and hypoxemia. The study will enroll 10 outpatient subjects aged ≥40 with a chronic bronchitis phenotype, confirmed COPD diagnosis, and a diffusing capacity of the lungs for carbon monoxide (DLCO) ≥45% predicted. All participants will receive inhaled Treprostinil via a 4-week dose titration protocol (starting at 3 breaths four times daily and increasing to 6 breaths as tolerated).
The primary objectives are to "determine the effects of inhaled Treprostinil on regional gas exchange and capillary blood oxygenation as measured by hyperpolarized xenon-129 magnetic resonance imaging (HP129Xe MRI), including ventilation defect percentage (VDP), membrane defect percentage, red blood cell (RBC) transfer defect percentage and normalized RBC oscillation amplitude and RBC frequency shift," and to "determine whether pre-treatment VDP, membrane defect percentage, RBC transfer defect percentage, RBC chemical shift and normalized RBC oscillation amplitude predict a positive response to inhaled Treprostinil."
Assessments will include HP129Xe MRI, spirometry with DLCO, 6-minute walk testing (6MWT), and echocardiography at baseline and after 4 weeks. Data will be analyzed for changes in regional lung function and oxygenation. Safety monitoring will focus on known adverse effects of inhaled Treprostinil including "cough, headache, hypotension, oropharyngeal pain, throat irritation and nausea," and will address more serious risks observed in the PERFECT trial (COPD exacerbation, respiratory failure, myocardial infarction, and death). By selecting subjects with DLCO ≥45% predicted and using a shorter 4-week treatment duration with titrated dosing, the study aims to mitigate these risks.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Inhaled Treprostinil in COPD Patients With Hypoxemia and Preserved DLCO | Experimental | Drug: Inhaled Treprostinil (Tyvaso Nebulizer) |
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Outpatients of either gender, age ≥ 40.
- Clinical evidence of chronic bronchitis (a productive cough lasting more than 3 months within a 2-year period).
- Current or former cigarette smokers with a smoking history of 20 or more pack-years.
- Clinical diagnosis of chronic obstructive pulmonary disease (COPD) confirmed by spirometry demonstrating forced expiratory volume in 1 second (FEV1) to forced vital capacity (FVC) ratio < 0.70, pre-bronchodilator FEV1 ≥ 30% predicted, and diffusing capacity of the lungs for carbon monoxide (DLCO) ≥ 45% predicted.
- On stable maintenance COPD medications including inhaled corticosteroids (ICS), long-acting beta agonists (LABA), long-acting muscarinic antagonists (LAMA), combination inhalers, azithromycin, or roflumilast (with no changes over the past 3 months).
Key exclusion criteria (16 listed)
- Upper respiratory tract infection within 6 weeks (participants may be rescreened after this period).
- History of lung resection surgery or pleural decortication.
- Previous history of pneumothorax.
- Imaging evidence of interstitial lung disease, occupational lung disease, or chronic infectious lung disease.
- History of asthma.
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 |
|---|---|---|
| Inhaled Treprostinil (Tyvaso Nebulizer)Participants will receive inhaled Treprostinil (Tyvaso nebulizer), 6 µg per breath, administered four times daily for 4 weeks. The starting dose will be 3 breaths per session. The dose will increase by 1 breath per session each week, as tolerated, to a target of 6 breaths per session by week 4. If adverse effects occur, participants will remain at the highest tolerated dose. The drug will be administered using the Tyvaso inhalation system provided by United Therapeutics. No changes to baseline COPD maintenance medications are allowed during the treatment period. Participants will be monitored for safety throughout the study. | Drug | Inhaled Treprostinil in COPD Patients With Hypoxemia and Preserved DLCO |
Primary outcome
Ventilation Defect Percentage (VDP) on HP129XeMRI
Time frame: Baseline and 4 weeks post-Tyvaso
Defined as the region with ventilation signals < mean - 2SD, measured by HP129XeMRI and expressed as a percentage of total lung volume.
Membrane Defect Percentage on HP129XeMRI
Time frame: Baseline and 4 weeks post-Tyvaso
Defined as the region with membrane signals < mean - 2SD, measured by HP129XeMRI and expressed as a percentage of total lung volume.
Low Membrane Region Percentage on HP129XeMRI
Time frame: Baseline and 4 weeks post-Tyvaso
Defined as the region with membrane signals between 1SD and 2SD below the mean, measured by HP129XeMRI and expressed as a percentage of total lung volume.
RBC Transfer Defect Percentage on HP129XeMRI
Time frame: Baseline and 4 weeks post-Tyvaso
Defined as the region with RBC transfer signals < mean - 2SD, measured by HP129XeMRI and expressed as a percentage of total lung volume.
Low RBC Transfer Region Percentage on HP129XeMRI
Time frame: Baseline and 4 weeks post-Tyvaso
Defined as the region with RBC transfer signals between 1SD and 2SD below the mean, measured by HP129XeMRI and expressed as a percentage of total lung volume.
RBC Oscillation Amplitude Normalized for RBC Transfer Defect
Time frame: Baseline and 4 weeks post-Tyvaso
Measured using HP129XeMRI spectroscopy as a surrogate for pulmonary vascular resistance, normalized to RBC transfer signal intensity.
RBC Chemical Shift on HP129XeMRI Spectroscopy
Time frame: Baseline and 4 weeks post-Tyvaso
Frequency shift in RBC signal reflecting capillary blood oxygenation, measured using HP129XeMRI spectroscopy.
11 secondary outcomes
Nadir SpO₂ During 6MWT
Time frame: Baseline and 4 weeks post-Tyvaso treatment
Supplemental Oxygen Flow During 6MWT
Time frame: Baseline and 4 weeks post-Tyvaso treatment
6-Minute Walk Distance (6MWD)
Time frame: Baseline and 4 weeks post-Tyvaso treatment
Dyspnea Score During 6MWT
Time frame: Baseline and 4 weeks post-Tyvaso treatment
Peak Heart Rate (% Predicted) During 6MWT
Time frame: Baseline and 4 weeks post-Tyvaso treatment
Forced Expiratory Volume in 1 Second (FEV1) - Absolute and % Predicted
Time frame: Baseline and 4 weeks post-Tyvaso treatment
Forced Vital Capacity (FVC) - Absolute and % Predicted
Time frame: Baseline and 4 weeks post-Tyvaso treatment
Total Lung Capacity (TLC) - Absolute and % Predicted
Time frame: Baseline and 4 weeks post-Tyvaso treatment
Residual Volume (RV) - Absolute and % Predicted
Time frame: Baseline and 4 weeks post-Tyvaso treatment
Diffusing Capacity for Carbon Monoxide (DLCO) - Absolute and % Predicted
Time frame: Baseline and 4 weeks post-Tyvaso treatment
Carbon Monoxide Transfer Coefficient (KCO) - Absolute and % Predicted
Time frame: Baseline and 4 weeks post-Tyvaso treatment
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 27 Aug 2026.
- Individual participant dataSharing planned: No. Individual participant data (IPD) will not be shared for this study. The consent form limits future data use to internal research on lung disease and COPD and does not authorize sharing of de-identified IPD with external investigators. Therefore, data cannot be made available to other researchers outside of the study team.
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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.
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 Inhaled Treprostinil (Tyvaso Nebulizer) in people with COPD (Chronic Obstructive Pulmonary Disease) and Hypoxemia, run by Bastiaan Driehuys at 1 site in United States.
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 8 inclusion and 16 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: looking for participants now, as of the sponsor's last update on 27 Aug 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 United States. 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. 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?
Contact Yuh-Chin Huang, M.D., M.H.S., MD (919-684-3069, yuhchin.huang@duke.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Ventilation Defect Percentage (VDP) on HP129XeMRI (time frame: Baseline and 4 weeks post-Tyvaso). The study lists 7 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 27 Aug 2026.