Effects of positive airway pressure on mucus treatment in asthma and COPD

The Effects of Positive Airway Pressure on the Mucolytic Effects of NAC

This study is testing if using a special breathing device that adds pressure can help people with asthma or COPD get a mucus treatment into their lungs more effectively.

Quick facts

• Phase: Phase 4
• Study type: Interventional
• Enrollment: 40 (estimated)
• Ages: 18 Years to 85 Years
• Sex: All
• Sponsor: University of California, San Francisco (Academic / other)
• Locations: 1 site (San Francisco, California)
• Trial ID: NCT06152653 on ClinicalTrials.gov

What this trial studies

This clinical trial aims to evaluate whether positive pressure during inhalation enhances the delivery of aerosolized N-Acetylcysteine (NAC) to mucus plugs in the lungs of patients with asthma or Chronic Obstructive Pulmonary Disease (COPD). Participants will be assigned to receive NAC through either a standard nebulizer or a specialized device that applies positive pressure during inhalation. The study will assess the effectiveness of these methods in reducing mucus burden and improving lung function over a series of treatment visits. The trial employs a single-blind design and utilizes a CT-based scoring system to quantify mucus plug burden.

Who should consider this trial

Good fit: Ideal candidates include adults aged 18 to 85 with a clinical history of asthma requiring treatment with inhaled corticosteroids or biologic therapy.

Not a fit: Patients with asthma or COPD who do not have significant mucus plug burden or who cannot tolerate the study treatments may not benefit from this study.

Why it matters

Potential benefit: If successful, this approach could significantly improve mucus clearance and lung function in patients with asthma and COPD.

How similar studies have performed: Previous studies have shown promise in using positive pressure techniques for aerosol delivery, but this specific approach is novel.

Eligibility criteria

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

Where this trial is running

San Francisco, California

• UCSF Airway Clinical Research Center — San Francisco, California, United States (Recruiting)

Study contacts

• Principal investigator: John Fahy, MD, MS — Professor of Medicine
• Study coordinator: Jade Vi, BS

Conditions Asthma; COPD; Mucolytic; Mucus Plug; Positive Pressure; NAC