The Effect of NAC on Lung Function and CT Mucus Score

Launched by UNIVERSITY OF CALIFORNIA, SAN FRANCISCO · Jan 28, 2019

Keywords

ClinConnect Summary

This clinical trial is investigating how a medication called 20% n-acetylcysteine (NAC) affects lung function and mucus levels in people with moderate-to-severe asthma. The study involves a crossover design, which means that participants will receive either NAC or a placebo (a substance with no active effect) in two separate 14-day treatment periods. Half of the participants will start with NAC and then switch to the placebo, while the other half will do the opposite. The goal is to see if NAC can help improve lung function and reduce mucus in the airways as seen on CT scans.

To participate in this trial, you need to be between 18 and 80 years old and have a history of asthma that requires treatment. You should also have evidence of airflow issues in your lungs and a specific amount of mucus in your airways as shown on a CT scan. Participants can expect to follow specific study procedures and undergo tests to monitor their lung function. It’s important to know that certain health conditions, such as other serious lung diseases or recent smoking, may exclude you from participation for safety reasons. If you’re interested, you’ll need to provide informed consent and agree to follow the study guidelines.

Gender

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Eligibility criteria

• Inclusion Criteria:
• • 1. Male or female between the ages of 18 and 80 years of age 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. Physiological evidence of airflow obstruction (FEV1 bronchodilator reversibility of ≥ 12% or hyperreactivity to methacholine reflected by a methacholine provocative concentration that results in a 20% fall in FEV1(PC20) ≤ 16 mg/mL)
• • 5. Clinical history of asthma per patient report or medical record
• • 6. Pre-bronchodilator FEV1 \> 35% predicted
• • 7. Post-bronchodilator FEV1 \> 40% but \< 90% predicted
• • 8. Asthma requiring treatment with inhaled corticosteroids (ICS) for 3 months or greater
• • 9. CT mucus score ≥ 5
• • 10. Ability to tolerate study drug reflected by a post-treatment FEV1 ≥ 80% of pre- treatment, pre-bronchodilator FEV1
• Exclusion Criteria:
• • 1. Pregnant, breastfeeding, or unwilling to practice birth control during participation in the study
• • 2. Presence of a condition or abnormality that in the opinion of the Investigator would compromise the safety of the patient or the quality of the data
• • 3. Smoking of tobacco or other recreational inhalants in last year and/or \>10 pack-year smoking history
• • 4. Adherence to study drug ≤ 70% after first treatment period
• • 5. Current participation in an investigational drug trial
• • 6. Other chronic pulmonary disorders, including (but not limited to) cystic fibrosis, chronic obstructive pulmonary disease, chronic bronchitis, vocal cord dysfunction (that is the sole cause of respiratory symptoms and at the PI's discretion), severe scoliosis or chest wall deformities that affect lung function, or congenital disorders of the lungs or airways
• • 7. Unwillingness to follow study procedures
• • 8. History of allergy or intolerance to study drug
• • 9. Any other criteria that places the subject at unnecessary risk according to the judgment of the Principal Investigator