NCT07037836 · Bastiaan Driehuys
Inhaled Treprostinil (Tyvaso Nebulizer) For COPD Patients With Hypoxemia
(Tyvaso)
What this study is about
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.
View original scientific description
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.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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
- Durham, North Carolina
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Oct 30, 2025 · Source of record for eligibility and locations