A Phase 2 interventional study of Inhaled Treprostinil (Tyvaso Nebulizer) in COPD (Chronic Obstructive Pulmonary Disease) and Hypoxemia, sponsored by Bastiaan Driehuys. Recruiting at 1 site in United States. Open to participants aged 40 Years and older. Per ClinicalTrials.gov, last updated 2026-08-27.
Sponsored by Bastiaan Driehuys · Phase 2, Interventional, and Treatment
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:
Participants will:
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.
5,520 studies on the registry are indexed under Pulmonary Disease, Chronic Obstructive; 856 are open to participants now.
This study's planned enrollment of 10 is below the median of 62 across 3,839 interventional studies indexed under Pulmonary Disease, Chronic Obstructive.
Browse Pulmonary Disease, Chronic Obstructive studies →Bastiaan Driehuys is the lead sponsor of 18 studies on the registry; 9 are open to participants now.
Of its 6 completed or terminated interventional studies of FDA-regulated products, 6 (100%) have results posted.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria
For Magnetic Resonance Imaging (MRI):
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Chronic obstructive pulmonary disease: long-term lung disease that makes it hard to breathe out, including emphysema and chronic bronchitis.
From a breathing test (spirometry): how much air you can blow out in the first second. Often given as a percentage of what is expected for your age, height and sex.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
COPD
Chronic obstructive pulmonary disease: long-term lung disease that makes it hard to breathe out, including emphysema and chronic bronchitis.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
FEV1
From a breathing test (spirometry): how much air you can blow out in the first second. Often given as a percentage of what is expected for your age, height and sex.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Childbearing potential
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Drug: 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.
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: Baseline and 4 weeks post-Tyvaso
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%.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: Baseline and 4 weeks post-Tyvaso treatment
Plan to share: 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.
No publications or documents are linked to this record.
Started Sep 2025 (actual). Primary completion is estimated for Jul 2027, 21 months after the start.
Of 47 non-industry phase 2 interventional studies under Pulmonary Disease, Chronic Obstructive, half reached primary completion within 39 months of starting (the median), counting those still running; a quarter within 20 and three quarters within 63. This study's planned 21 months is below that.
Counting every sponsor, half of 165 studies reached it within 17 months; a quarter within 10 and three quarters within 31.
How these figures are worked out, and which studies are left out of them.
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Studies of the drug tested here: Treprostinil
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