Status:
TERMINATED
The Effect of NAC on Lung Function and CT Mucus Score
Lead Sponsor:
University of California, San Francisco
Conditions:
Asthma
Eligibility:
All Genders
18-80 years
Phase:
PHASE4
Brief Summary
This study evaluates 20% n-acetylcysteine (NAC) in the treatment of moderate-to-severe asthma that is complicated by mucus in the airway, as determined by CT imaging. The study is a crossover design, ...
Detailed Description
N-acetylcystine (NAC) is a mucolytic medication, meaning that it breaks apart mucus. Investigators know that mucus is a factor in severe asthma attacks. However, mucus may be a factor in chronic sever...
Eligibility Criteria
Inclusion
- Male or female between the ages of 18 and 80 years of age at Visit 1
- Written informed consent obtained from subject and ability for subject to comply with the requirements of the study.
- Able to perform reproducible spirometry according to American Thoracic Society (ATS) criteria
- 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)
- Clinical history of asthma per patient report or medical record
- Pre-bronchodilator FEV1 \> 35% predicted
- Post-bronchodilator FEV1 \> 40% but \< 90% predicted
- Asthma requiring treatment with inhaled corticosteroids (ICS) for 3 months or greater
- CT mucus score ≥ 5
- Ability to tolerate study drug reflected by a post-treatment FEV1 ≥ 80% of pre- treatment, pre-bronchodilator FEV1
Exclusion
- Pregnant, breastfeeding, or unwilling to practice birth control during participation in the study
- 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
- Smoking of tobacco or other recreational inhalants in last year and/or \>10 pack-year smoking history
- Adherence to study drug ≤ 70% after first treatment period
- Current participation in an investigational drug trial
- 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
- Unwillingness to follow study procedures
- History of allergy or intolerance to study drug
- Any other criteria that places the subject at unnecessary risk according to the judgment of the Principal Investigator
Key Trial Info
Start Date :
February 20 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 21 2025
Estimated Enrollment :
4 Patients enrolled
Trial Details
Trial ID
NCT03822637
Start Date
February 20 2019
End Date
February 21 2025
Last Update
March 3 2025
Active Locations (1)
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1
UCSF Airway Clinical Research Center
San Francisco, California, United States, 94143