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TERMINATED

NCT03822637

PHASE4

The Effect of NAC on Lung Function and CT Mucus Score

Sponsor: University of California, San Francisco

View on ClinicalTrials.gov

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, which means that half the study participants will get 20% NAC in the first 14-day treatment period and placebo in the next 14-day treatment period; and the other half will get placebo in the first 14-day treatment period and 20% NAC in the next 14-day treatment period.

Key Details

Gender

All

Age Range

18 Years - 80 Years

Study Type

INTERVENTIONAL

Enrollment

Start Date

2019-02-20

Completion Date

2025-02-21

Last Updated

2026-06-11

Healthy Volunteers

Conditions

Asthma

Interventions

COMBINATION_PRODUCT

n-acetylcystine + albuterol

NAC (trade name: Mucomyst) is a mucolytic drug manufactured by American Regent. The active drug studied here is 20% NAC (3 mL) and 2.5 mg albuterol bronchodilator inhalation solution (0.5 mL).

COMBINATION_PRODUCT

0.9% saline + albuterol

The placebo comparator in this study is 0.9% normal saline (3 mL) and 2.5 mg albuterol inhalation solution (0.5 mL).

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

Locations (1)

UCSF Airway Clinical Research Center

San Francisco, California, United States