RecruitingPhase 4NCT06152653

The Effects of Positive Airway Pressure on the Mucolytic Effects of NAC (TEAM)

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


Sponsor

University of California, San Francisco

Enrollment

40 participants

Start Date

Apr 9, 2024

Study Type

INTERVENTIONAL

Conditions

Summary

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.


Eligibility

Min Age: 18 YearsMax Age: 85 Years

Plain Language Summary

Simplified for easier understanding

This trial (TEAM) is studying whether combining a drug called NAC (N-acetylcysteine, which thins mucus in the airways) with positive airway pressure (PAP, a breathing device similar to a CPAP machine) can better clear mucus blockages in the lungs of people with asthma or COPD. Mucus plugging is a significant problem in both conditions and can worsen breathing. **You may be eligible if...** - You have asthma treated with inhaled steroids or a biologic medication for at least 3 months, with evidence of mucus plugging on a CT scan, OR - You have COPD confirmed by lung function testing, with a smoking history of at least 10 pack-years, and evidence of mucus plugging on CT scan - You are 18–85 years old **You may NOT be eligible if...** - You are currently pregnant - You have had an upper respiratory infection (cold or respiratory illness) in the past 10 days - You have a significant medical condition that, in the doctor's judgment, puts you at extra risk from the study procedures Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGn-acetylcystine (NAC)+ albuterol

NAC is a mucolytic drug and Albuterol is a bronchodilator.

DEVICEAeroEclipse-VersaPAP System

The AeroEclipse-VersaPAP System combine continuous positive inspiratory pressure and nebulizer in one system.


Locations(1)

UCSF Airway Clinical Research Center

San Francisco, California, United States

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NCT06152653


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