Inhaled Treprostinil (Tyvaso Nebulizer) For COPD Patients With Hypoxemia

Launched by YUH CHIN T HUANG, MD, MHS · Jun 17, 2025

Keywords

ClinConnect Summary

This clinical trial is studying whether a medication called inhaled Treprostinil (delivered through the Tyvaso nebulizer) can help adults with COPD (a chronic lung disease) who also have low oxygen levels in their blood. The researchers want to see if this treatment can improve blood flow and oxygen delivery in the lungs, especially in people whose lungs still have a moderate ability to transfer oxygen into the blood. They will use special lung scans and breathing tests to measure these effects before and after four weeks of treatment.

To take part, you need to be 40 years or older, have COPD confirmed by breathing tests, and have a history of smoking. You should also be using oxygen at rest or during activity but not require high amounts. During the study, participants will inhale the medication four times a day, gradually increasing the dose as they can tolerate it. They will have lung scans, breathing tests, a walking test, and heart ultrasounds at the start and end of the study. The team will check in by phone during treatment to monitor safety. This study is not yet recruiting but aims to find out if inhaled Treprostinil might be a helpful treatment option for people with COPD and low oxygen levels.

Gender

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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.