Overview

The Effect of NAC on Lung Function and CT Mucus Score

Status:
Recruiting

Trial end date:
2022-03-01

Target enrollment:
0

Participant gender:
All

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.

Phase:

Phase 4

Accepts Healthy Volunteers?

Details

Lead Sponsor:

University of California, San Francisco

Treatments:

Acetylcysteine
Albuterol
N-monoacetylcystine

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