The Effects of Positive Airway Pressure on the Mucolytic Effects of NAC
University of California, San Francisco
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.
Description
The optimal method for delivering aerosolized N-acetyl cysteine (NAC, Mucomyst) to the airways for the purpose of lysing mucus plugs is not established. The challenge is to ensure that the NAC aerosol penetrates the mucus plug to lyse it. We hypothesize that increasing the inspiratory pressure during aerosol inhalation will improve mixing of NAC with plugs and increase the chance of lysis within the time that the NAC liquid medication "dwells" in the plugged airway segment. Usual nebulizer systems that generate aerosols for inhalation do not allow for application of pressure during inspiration…
Eligibility
- Age range
- 18–85 years
- Sex
- All
- Healthy volunteers
- No
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…
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.
Location
- UCSF Airway Clinical Research CenterSan Francisco, California