TEAMThe Effects of Positive Airway Pressure on the Mucolytic Effects of NAC
n-acetylcystine (NAC)+ albuterol
+ AeroEclipse-VersaPAP System
Asthma+11
+ Bronchial Diseases
+ Chronic Disease
Treatment Study
Summary
Study start date: April 9, 2024
Actual date on which the first participant was enrolled.This clinical trial explores the best way to deliver a medication called N-acetyl cysteine (NAC) to help break down thick mucus plugs in the lungs of people with asthma and COPD. These plugs can make breathing difficult and are a common problem in these conditions. The study aims to find out if using a special device called the VersaPAP, which applies gentle pressure while inhaling the medication, can better mix the medication with the mucus and help dissolve it effectively. Understanding how to deliver NAC more efficiently could significantly improve the management of mucus-related lung issues, offering relief to those affected. Participants in the study will undergo CT scans to check for mucus in their lungs. Those eligible will be divided into two groups: one using a standard nebulizer and the other using the VersaPAP system to inhale NAC along with albuterol, a medication that helps open the airways. Over 30 days, participants will attend five treatment sessions, each involving two inhalations of the medication mixture, four hours apart. The study will observe the effects of the different delivery methods on the mucus in the lungs, using the CT imaging as a way to measure the results. The potential benefit is finding a more effective way to clear mucus and improve breathing in patients with these lung conditions.
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.40 patients to be enrolled
Total number of participants that the clinical trial aims to recruit.Treatment Study
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.Any sex
Biological sex of participants that are eligible to enroll.From 18 to 85 Years
Range of ages for which participants are eligible to join.Healthy volunteers not allowed
If individuals who are healthy and do not have the condition being studied can participate.Conditions
Pathology
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
Study Plan
Find out more about all the medication administered in this study, their detailed description and what they involve.2 intervention groups are designated in this study
This study does not include a placebo group
Treatment Groups
Group I
ExperimentalGroup II
Active ComparatorStudy Objectives
Primary Objectives
Study Centers
These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.This study has 1 location
UCSF Airway Clinical Research Center
San Francisco, United StatesOpen UCSF Airway Clinical Research Center in Google Maps