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Inhaled Treprostinil for COPD with Hypoxemia

This study is testing whether inhaled Treprostinil (Tyvaso Nebulizer) can improve how oxygen is delivered and blood flows in the lungs of adults (age 40 and older) who have chronic obstructive pulmonary disease (COPD) and low oxygen levels (hypoxemia). Participants will receive inhaled Treprostinil four times a day for four weeks, with the dose gradually increasing as tolerated. Researchers will use a special MRI scan (HP129Xe MRI) to see if the treatment improves lung function, specifically looking at how well air and blood move through the lungs. You may be eligible if you have COPD with chronic bronchitis, a history of smoking, and a certain level of lung function.

Study design
This is a single-arm study, meaning all 10 participants will receive the same treatment. It is a proof-of-concept study, which means it's an early look at how the treatment works.
What's involved
You would receive inhaled Treprostinil four times daily for four weeks. You would also have assessments like HP129Xe MRI, lung function tests (spirometry with DLCO), a 6-minute walk test, and an echocardiogram at the beginning and end of the 4-week treatment period.
Compensation
Not stated in the trial record.
Follow-up
Assessments are measured at Baseline and 4 weeks post-Tyvaso, indicating a follow-up period of at least 4 weeks.

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NCT07037836

Inhaled Treprostinil (Tyvaso Nebulizer) For COPD Patients With Hypoxemia

Recruiting
PHASE2Ages 40+InterventionalTreatment
Bastiaan Driehuys
~10 participants
Updated 2026-08-27 on ClinicalTrials.gov
What's tested:Inhaled Treprostinil (Tyvaso Nebulizer)

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Ventilation Defect Percentage (VDP) on HP129XeMRI
Measured over Baseline and 4 weeks post-Tyvaso
+6 more outcomes measured

Conditions

COPD (Chronic Obstructive Pulmonary Disease)
Hypoxemia

Explore related trials

Chronic Obstructive Pulmonary DiseaseHypoxemia

Where it's being run

1 sites across 1 states
North Carolina1

Who to contact

Yuh-Chin Huang, M.D., M.H.S., MD
[email protected]
919-684-3069
Email the study team

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Eligibility criteria

Inclusion

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.

Exclusion

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.
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.
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.

What this trial measures

  • Ventilation Defect Percentage (VDP) on HP129XeMRIBaseline 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 HP129XeMRIBaseline 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 HP129XeMRIBaseline 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 HP129XeMRIBaseline 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 HP129XeMRIBaseline 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 DefectBaseline 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 SpectroscopyBaseline and 4 weeks post-Tyvaso

    Frequency shift in RBC signal reflecting capillary blood oxygenation, measured using HP129XeMRI spectroscopy.