Actively Recruiting
The Effects of Positive Airway Pressure on the Mucolytic Effects of NAC (TEAM)
Led by University of California, San Francisco · Updated on 2025-07-30
40
Participants Needed
1
Research Sites
155 weeks
Total Duration
On this page
Sponsors
U
University of California, San Francisco
Lead Sponsor
N
National Heart, Lung, and Blood Institute (NHLBI)
Collaborating Sponsor
AI-Summary
What this Trial Is About
The goal of this clinical trial is to determine if positive pressure during inspiration will improve penetration of aerosolized N-Acetylcysteine (NAC) into airway mucus plugs in the lungs of patients with asthma or Chronic Obstructive Pulmonary Disease (COPD). The main questions it aims to answer are: * Does delivery of aerosolized NAC with positive inspiratory pressure have a greater effect on mucus plug burden in the lungs than delivery of NAC without positive pressure. * Does delivery of aerosolized NAC with positive inspiratory pressure have a greater effect on lung function than delivery of NAC without positive pressure. Participants will be assigned (in a single blind design) to the NAC via jet nebulizer group or the NAC via AeroEclipse-VersaPAP nebulizer group. Participants will each complete 5 treatment visits over the course of 30 days. Each treatment visit will consist of two treatments of a 10% NAC (3 mL) and 2.5 mg albuterol (0.5mL) inhalation solution separated by 4 hours, via the nebulization method specific to their group.
CONDITIONS
Official Title
The Effects of Positive Airway Pressure on the Mucolytic Effects of NAC (TEAM)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adults aged 18 to 85 years
- Ability to give written informed consent and comply with study requirements
- Able to perform reproducible spirometry according to ATS criteria
- Clinical history of asthma or COPD confirmed by patient report or medical record
- Asthma patients treated with inhaled corticosteroids or biologic therapy for at least 3 months
- COPD patients with FEV1/FVC ratio under 70% and history of at least 10 pack-years smoking
- CT mucus score of 3 or higher
- Ability to tolerate study treatment with post-treatment FEV1 at least 80% of pre-treatment FEV1
- For participants with known mucus plugging on CT: no FEV1 limit
- For participants with unknown mucus plugging: FEV1 less than 70% predicted for asthma, less than 50% predicted for COPD
You will not qualify if you...
- Any medical condition that increases risk or may affect study results as judged by investigator
- Currently pregnant
- Upper respiratory infection within the past 10 days
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Trial Site Locations
Total: 1 location
1
UCSF Airway Clinical Research Center
San Francisco, California, United States, 94143
Actively Recruiting
Research Team
J
Jade Vi, BS
CONTACT
J
John Fahy, MD, MS
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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