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

Inhaled Treprostinil (Tyvaso Nebulizer) For COPD Patients With Hypoxemia

This study will see if inhaled Treprostinil (Tyvaso) can increase lung blood flow and oxygen delivery in adults with COPD who have low oxygen levels.

Quick facts

• Phase: Phase 2
• Study type: Interventional
• Enrollment: 10 (estimated)
• Ages: 40 Years and up
• Sex: All
• Sponsor: Duke University (Academic / other)
• Locations: 1 site (Durham, North Carolina)
• Trial ID: NCT07037836 on ClinicalTrials.gov

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.

Who should consider this trial

Good fit: Adults aged ≥40 with a clinical chronic bronchitis COPD phenotype, smoking history ≥20 pack-years, spirometric airflow obstruction (FEV1/FVC <0.70 and pre-bronchodilator FEV1 ≥30% predicted), DLCO ≥45% predicted, on stable COPD meds, and using ≤4 L/min supplemental oxygen are the intended participants.

Not a fit: Patients with more advanced pulmonary vascular disease or markedly reduced DLCO (<45%), very severe airflow obstruction, or who cannot tolerate inhaled prostacyclin are less likely to benefit from this intervention.

Why it matters

Potential benefit: If successful, inhaled Treprostinil could improve regional lung blood flow and oxygen delivery and potentially reduce hypoxemia and improve exercise tolerance for some COPD patients.

How similar studies have performed: Inhaled Treprostinil has shown clinical benefit in pulmonary hypertension related to interstitial lung disease, but applying it to COPD with hypoxemia and measuring regional responses with HP129Xe MRI is largely novel.

Eligibility criteria

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 this trial is running

Durham, North Carolina

• 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

Conditions COPD; Hypoxemia; Tyvaso