Recruiting
Phase 2

Treprostinil

Sponsor:

Bastiaan Driehuys

Code:

NCT07037836

Conditions

COPD (Chronic Obstructive Pulmonary Disease)

Hypoxemia

Eligibility Criteria

Sex: All

Age: 40+

Healthy Volunteers: Not accepted

Interventions

Inhaled Treprostinil (Tyvaso Nebulizer)

Study Details

Brief 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 carbon monoxide \[DLCO\] ≥45%).

The main questions it aims to answer are:

1. Does inhaled Treprostinil increase pulmonary capillary blood volume in ventilated lung regions, as measured by hyperpolarized xenon-129 magnetic resonance imaging (HP129Xe MRI)?
2. 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)?
3. 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.

Conditions

COPD (Chronic Obstructive Pulmonary Disease)

Hypoxemia

Study ID

NCT07037836

Start date

Sep 29, 2025

Status verified date

Aug, 2026

Completion date

Jul 1, 2027

Anticipated

Primary completion date

Jul 1, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 40+

Healthy Volunteers: Not accepted

Inclusion Criteria

  • 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 Criteria

  • 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.

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.

Study Design

Enrollment

10 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Inhaled Treprostinil in COPD Patients With Hypoxemia and Preserved DLCO

Interventions

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.

Primary outcome measure

  • Ventilation Defect Percentage (VDP) on HP129XeMRI [ Time Frame: Baseline and 4 weeks post-Tyvaso ]
  • Membrane Defect Percentage on HP129XeMRI [ Time Frame: Baseline and 4 weeks post-Tyvaso ]
  • Low Membrane Region Percentage on HP129XeMRI [ Time Frame: Baseline and 4 weeks post-Tyvaso ]
  • RBC Transfer Defect Percentage on HP129XeMRI [ Time Frame: Baseline and 4 weeks post-Tyvaso ]
  • Low RBC Transfer Region Percentage on HP129XeMRI [ Time Frame: Baseline and 4 weeks post-Tyvaso ]
  • RBC Oscillation Amplitude Normalized for RBC Transfer Defect [ Time Frame: Baseline and 4 weeks post-Tyvaso ]
  • RBC Chemical Shift on HP129XeMRI Spectroscopy [ Time Frame: Baseline and 4 weeks post-Tyvaso ]

Central Contacts and Locations

Central contacts

Yuh-Chin Huang, M.D., M.H.S., MD

919-684-3069yuhchin.huang@duke.edu

Savannah Barbieri

919-613-0740savannah.barbieri@duke.edu

Locations

Duke Asthma Allergy and Airway Center

Recruiting

Durham, North Carolina, United States, 27705

Contacts

Savannah Barbieri

919613740savannah.barbieri@duke.edu

Jessica Shier

jessica.shier@duke.edu

Principal Investigator:

Yuh-Chin Huang, MD

More Information

Sponsor

Bastiaan Driehuys

Last update posted

Aug 27, 2026

Last verified

Aug, 2026

Keywords

  • Tyvaso
  • COPD
  • Hypoxemia

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Bastiaan Driehuys on 2026-08-27.