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New inhaler treatment aims to boost oxygen in COPD lungs

NCT ID NCT07037836

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

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

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

About 10 people

The number the study aims to enrol. It can still change while the study runs.

Started

Sep 2025

Expected to finish

Jul 2027

An estimate. End dates often move.

Lead sponsor

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

40 years and older

Sex

Anyone

Healthy volunteers

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

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.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. 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

  • Duke Asthma Allergy and Airway Center

    RECRUITING

    Durham, North Carolina, 27705, United States

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