New inhaler treatment aims to boost oxygen in COPD lungs
NCT ID NCT07037836
First seen Jun 25, 2026 · Last updated Aug 28, 2026 · Updated 3 times
Summary
This phase 2 trial is testing whether an inhaled drug called treprostinil (Tyvaso) can improve oxygen delivery in the lungs of people with COPD who have low blood oxygen. Ten adults will use the nebulizer four times daily for four weeks, starting at a low dose and increasing as tolerated. Researchers will use special MRI scans to measure changes in lung blood flow and oxygen exchange before and after treatment.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Inhaled treprostinil (Tyvaso nebulizer)
- What this could lead to
- If it works, this could point toward a new treatment to improve oxygen delivery and lung function in COPD patients with low blood oxygen.
- What could go wrong
- This is a very small, early-phase trial with only 10 participants, so results may not apply to everyone. The drug may cause side effects and may not show clear benefit.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
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About 10 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Sep 2025
- Expected to finish
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Jul 2027
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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40 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Duke Asthma Allergy and Airway Center
RECRUITINGDurham, North Carolina, 27705, United States
More trials for these conditions
Other studies related to the condition(s) this trial covers.
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- Six biologics put to the test in Real-World asthma and COPD care
- Can a breathing routine ease COPD breathlessness?
- Switching to a nebulizer may help COPD patients who get no relief from inhalers
- Can extra oxygen during rehab change how COPD patients breathe?