Can pressurized breathing boost mucus clearance in lung disease?
NCT ID NCT06152653
First seen Aug 13, 2026 · Last updated Aug 14, 2026 · Updated 1 time
Summary
This trial investigates whether delivering a mucus-thinning medication (NAC) with positive airway pressure improves its ability to clear mucus plugs in the lungs of people with asthma or COPD. Participants will receive NAC plus albuterol through either a standard nebulizer or a device that adds positive pressure during inhalation. The study will compare changes in mucus plug burden and lung function between the two delivery methods over five treatment visits.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- N-acetylcysteine (NAC) combined with albuterol, delivered via a nebulizer with or without positive airway pressure
- What this could lead to
- If successful, this could lead to a more effective way to clear mucus plugs in asthma and COPD, potentially improving breathing and quality of life.
- What could go wrong
- This is a small, early-stage trial, and the benefit may not be significant or may not apply to all patients. NAC can cause side effects like nausea or bronchospasm.
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 4
Runs after approval, following long-term safety and how well the treatment works in everyday use.
- Participants
-
About 40 people
The number the study aims to enrol. It can still change while the study runs.
- Started
-
Apr 2024
- Expected to finish
-
Apr 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
-
18 to 85 years
- 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 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: Asthma Group: 1. Male or female between the ages of 18 to 85 at Visit 1 2. Written informed consent obtained from subject and ability for subject to comply with the requirements of the study. 3. Able to perform reproducible spirometry according to American Thoracic Society (ATS) criteria 4. Clinical history of asthma per patient report or medical record 5. Asthma requiring treatment with inhaled corticosteroids (ICS) or biologic therapy for 3 months or greater 6. Computed Tomography (CT) mucus score ≥ 3 (done as part of screening) 7. There is no lower threshold on Forced Expiratory Volume in the first second (FEV1), which means the study will attempt to enroll all patients regardless of asthma severity. However, eligible participants will need to demonstrate ability to tolerate study treatment reflected by a post-treatment FEV1 ≥ 80% of pre- treatment, pre-bronchodilator FEV1. Participants who have a \>20% drop in FEV1 after receiving any study treatment will be excluded from the study. 8. For participants with known mucus plugging on CT: no limit on FEV1; For participants with unknown mucus plugging: FEV1\<70% predicted COPD Group: 1. Males or females between the ages 18 to 85 at the time of visit 1. 2. Written informed consent obtained from subject and ability for subject to comply with the requirements of the study. 3. History of COPD per patient report or medical record and confirmed by an FEV1/FVC ratio of under 70%. 4. Current or former smoker with a history of at least 10 pack-years of smoking. 5. CT mucus score ≥ 3 6. There is no lower threshold on FEV1, which means the study will attempt to enroll all patients regardless of COPD severity. However, eligible participants will need to demonstrate ability to tolerate study treatment reflected by a post-treatment FEV1 ≥ 80% of pre- treatment, pre-bronchodilator FEV1. Participants who have a \>20% drop in FEV1 after receiving any study treatment will be excluded from the study. 7. For participants with known mucus plugging on CT: no limit on FEV1; For participants with unknown mucus plugging: FEV1\<50% predicted Exclusion Criteria: 1. A history of medical disease, which in the opinion of the investigator may put the subject at extra risk from study-related procedures or because the disease may influence the results of the study. 2. Currently pregnant 3. URI in past 10 days
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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.
Contacts and locations
Locations
-
UCSF Airway Clinical Research Center
San Francisco, California, 94143, United States
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