The Effect of NAC on Lung Function and CT Mucus Score

NCT03822637 | Terminated Phase 4 DMC FDA Drug

• 1 other identifier: 18-26680
• Study Type: interventional
• Target: 4
• Locations: 1 country
• Sites: 1

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, 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.

Conditions

Asthma

Outcome Measures

Primary Outcomes (1)

• Change in FEV1

  The primary outcome is the % change in FEV1 from the start to the end of each two-week treatment period (either placebo or 20% NAC).

  Through study completion, an average of 9 weeks

Study Arms (2)

20% n-acetylcystine (NAC)

EXPERIMENTAL

Participants self-administered nebulized 20% NAC (3 mL) and 2.5 mg albuterol inhalation solution (0.5 mL) 3 times per day for 14 days.

Drug: n-acetylcystine + albuterol

0.9% saline

PLACEBO COMPARATOR

Participants self-administered nebulized 0.9% saline (3 mL) and 2.5 mg albuterol inhalation solution (0.5 mL) 3 times per day for 14 days.

Drug: 0.9% saline + albuterol

Interventions

n-acetylcystine + albuterol DRUG

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).

Also known as: Mucomyst, NAC, n-acetylcystine

20% n-acetylcystine (NAC)

0.9% saline + albuterol DRUG

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

Also known as: Normal saline

0.9% saline

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of California, San Francisco: lead

Study Sites (1)

UCSF Airway Clinical Research Center

San Francisco, California, 94143, United States

Location

Related Publications (2)

• Hays SR, Fahy JV. The role of mucus in fatal asthma. Am J Med. 2003 Jul;115(1):68-9. doi: 10.1016/s0002-9343(03)00260-2. No abstract available.

  PMID: 12867239 BACKGROUND

• DUNNILL MS. The pathology of asthma, with special reference to changes in the bronchial mucosa. J Clin Pathol. 1960 Jan;13(1):27-33. doi: 10.1136/jcp.13.1.27.

  PMID: 13818688 BACKGROUND

MeSH Terms

Conditions

Asthma

Interventions

N-monoacetylcystine; Albuterol; Acetylcysteine; Sodium Chloride; Saline Solution

Condition Hierarchy (Ancestors)

Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Intervention Hierarchy (Ancestors)

Ethanolamines; Amino Alcohols; Alcohols; Organic Chemicals; Amines; Phenethylamines; Ethylamines; Cysteine; Amino Acids, Sulfur; Sulfur Compounds; Amino Acids; Amino Acids, Peptides, and Proteins; Chlorides; Hydrochloric Acid; Chlorine Compounds; Inorganic Chemicals; Sodium Compounds; Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations

Study Officials

• John Fahy, M.D, M.Sc.

  University of California, San Francisco

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 14, 2018
• First Posted: January 30, 2019
• Study Start: February 20, 2019
• Primary Completion: February 21, 2025
• Study Completion: February 21, 2025
• Last Updated: March 9, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)