Inhaled Treprostinil (Tyvaso) for people with COPD and low oxygen

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a single-arm, proof-of-concept Phase 2 study enrolling 10 outpatients aged 40 and older with a chronic bronchitis phenotype of COPD and DLCO ≥45% predicted. All participants will use inhaled Treprostinil delivered by the Tyvaso nebulizer with a 4-week dose-titration protocol given four times daily. Primary physiologic effects will be measured using hyperpolarized xenon-129 MRI to quantify regional ventilation, membrane and red blood cell (RBC) transfer defects, RBC chemical shift, and RBC oscillation amplitude. Secondary assessments include spirometry with DLCO, 6-minute walk distance, and echocardiography, with safety monitoring for known adverse effects of inhaled prostacyclin.

Why it matters

Who can join: the full rules

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.

Where it's running

• Duke Asthma Allergy and Airway Center
  Durham, North Carolina, United States Recruiting

Study contacts

• Study coordinator: Yuh-Chin Huang, M.D., M.H.S., MD
• Email: yuhchin.huang@duke.edu
• Phone: 919-684-3069

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.