Clinical Trial of NAC in Asthma

NCT02605824 | Terminated Phase 4 Results DMC FDA Drug

• 1 other identifier: 15-17919
• Study Type: interventional
• Target: 1
• Locations: 1 country
• Sites: 1

Brief Summary

This study evaluates 20% n-acetylcystine (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 7-day treatment period and placebo in the next 7-day treatment period; and the other half will get placebo in the first 7-day treatment period and 20% NAC in the next 7-day treatment period.

Conditions

Asthma

Outcome Measures

Primary Outcomes (1)

• Change in Post-bronchodilator FEV1 (L)

  This is a measure of forced expiratory volume measured in one second, following the administration of 4 puffs of albuterol. This outcome will compare the change in post-bronchodilator FEV1 (L) both before and after treatment.

  7 days

Secondary Outcomes (1)

• Change CT Mucus Score

  7 days

Study Arms (2)

20% n-acetylcystine (NAC)

EXPERIMENTAL

NAC (trade name: Mucomyst) is manufactured by American Regent. The active drug studied here is 20% NAC delivered via nebulizer three times per day for seven days.

Drug: n-acetylcystine

0.9% saline

PLACEBO COMPARATOR

Normal saline will be administered as the placebo agent via a nebulizer three times per day for seven days.

Drug: 0.9% saline

Interventions

n-acetylcystine DRUG

NAC is a mucolytic drug.

Also known as: Mucomyst, NAC, acetylcystine

20% n-acetylcystine (NAC)

0.9% saline DRUG

Normal saline is a placebo agent.

Also known as: Normal saline

0.9% saline

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Able to perform reproducible spirometry according to ATS criteria
• Clinical history consistent with moderate to severe asthma for 1 year or greater.
• Post-bronchodilator FEV1 \<90% of predicted
• Prescription and daily use of inhaled corticosteroid (ICS) equivalent to 240mcg of beclomethasone or greater and a second asthma controller therapy.
• CT mucus score \>3 (determined during the initial screening process, provided the prior two conditions are met)
• Written informed consent obtained from participant and ability for participant to comply with the requirements of the study.

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.
• History of intolerance to study medications.
• Current use of carbamazepine
• Angina which includes a treatment plan with PRN nitroglycerin or nitrites
• Smoking of tobacco or other recreational inhalants in last year and/or \>10 pack-year smoking history
• Current participation in an investigational drug trial Concurrent Medications

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

Related Links

• Study Center Website

MeSH Terms

Conditions

Asthma

Interventions

N-monoacetylcystine; Acetylcysteine; 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)

Cysteine; Amino Acids, Sulfur; Sulfur Compounds; Organic Chemicals; Amino Acids; Amino Acids, Peptides, and Proteins; Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations

Results Point of Contact

• Title: Fahy Research Manager
• Organization: UCSF Airway Clinical Research Center

ariana.baum@ucsf.edu

415-514-1539

Study Officials

• John V Fahy, MD, MSc

  University of California, San Francisco

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

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: November 12, 2015
• First Posted: November 16, 2015
• Study Start: March 1, 2016
• Primary Completion: December 1, 2017
• Study Completion: December 1, 2017
• Last Updated: August 20, 2019
• Results First Posted: August 20, 2019

Record last verified: 2019-07

Locations

US (1)