Inpatient Clinical Trial of NAC

NCT03581084 | Terminated Phase 4 Results DMC FDA Drug

• 2 other identifiers: 17-24231P01HL128191
• Study Type: interventional
• Target: 1
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to determine the beneficial effect of n-acetylcysteine (NAC), an inhaled medication that breaks down mucus, on lung function. NAC is a medication approved by the US Food and Drug Administration (FDA) for the treatment of chronic diseases of the respiratory system, including asthma. With CT lung imaging, the investigators seek to identify a subgroup of patients with asthma with a 'mucus' profile. This is a single-arm study which means all participants will receive the same treatment.

Conditions

Asthma

Outcome Measures

Primary Outcomes (1)

• Forced Expiratory Volume in One Second (FEV1) Measurement

  Post-treatment FEV1 is reported. FEV1 is measured via spirometry.

  end of the one week treatment period

Secondary Outcomes (1)

• Computed Tomography (CT) Scan Mucus Score

  From the start of the one week treatment period to the three month follow-up

Study Arms (1)

N-acetylcysteine

EXPERIMENTAL

This study will look at the effects of a medication, called n-acetylcysteine or NAC, on lung function. NAC is already approved for use in people with chronic airway conditions, including asthma. However, it is not known who this medication works best in. We believe this medication will likely have the most benefit in people with asthma that have mucus in their airways or "mucus plugging." Initial study procedures will include lung function measurements, a low dose CT scan, a blood draw, and a sputum induction. The CT lung imaging will identify asthmatics with mucus plugs.

Drug: N-acetylcysteine

Interventions

N-acetylcysteine DRUG

Research participants that meet the study inclusion criteria will be admitted to a medical-surgical ward in Moffitt-Long Hospital (UCSF Medical Center) for 6 days and 5 nights and treated with an inhaled mixture of NAC and albuterol four times per day spaced at 4 to 6 hours apart.

N-acetylcysteine

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 ATS criteria
• Physiological evidence of airflow obstruction (FEV1 bronchodilator reversibility of ≥ 12% or hyperreactivity to methacholine reflected by a methacholine 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 \> 3

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
• 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
• National Heart, Lung, and Blood Institute (NHLBI): collaborator

Study Sites (1)

University of California, San Francisco

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

Acetylcysteine

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Cysteine; Amino Acids, Sulfur; Sulfur Compounds; Organic Chemicals; Amino Acids; Amino Acids, Peptides, and Proteins

Results Point of Contact

• Title: Ariana Lowman
• Organization: UCSF Airway Clinical Research Center

ariana.baum@ucsf.edu

14155141539

Study Officials

• John Fahy, M.D, M.Sc.

  University of California, San Francisco

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: This is a single-arm study which means all study participants will receive the same treatment

Study Record Dates

• First Submitted: April 12, 2018
• First Posted: July 10, 2018
• Study Start: July 6, 2018
• Primary Completion: July 13, 2018
• Study Completion: October 6, 2018
• Last Updated: October 26, 2021
• Results First Posted: October 26, 2021

Record last verified: 2021-09

Locations

US (1)