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The Effect of NAC on Lung Function and CT Mucus Score (ENACT)

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ClinicalTrials.gov Identifier: NCT03822637
Recruitment Status : Not yet recruiting
First Posted : January 30, 2019
Last Update Posted : January 30, 2019
Sponsor:
Information provided by (Responsible Party):
University of California, San Francisco

Tracking Information
First Submitted Date  ICMJE December 14, 2018
First Posted Date  ICMJE January 30, 2019
Last Update Posted Date January 30, 2019
Estimated Study Start Date  ICMJE March 2019
Estimated Primary Completion Date March 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 28, 2019)
Change in FEV1 [ Time Frame: Through study completion, an average of 9 weeks ]
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).
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE The Effect of NAC on Lung Function and CT Mucus Score
Official Title  ICMJE The Effect of NAC on Lung Function and CT Mucus Score
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.
Detailed Description

N-acetylcystine (NAC) is a mucolytic medication, meaning that it breaks apart mucus. Investigators know that mucus is a factor in severe asthma attacks. However, mucus may be a factor in chronic severe asthma as well. This role has been hard to prove because of difficulty in showing that mucus occludes the lumen in chronic severe disease. Using a novel approach of scoring mucus occlusion, investigators have used CT imaging to uncover that a majority of people with severe asthma have at least one lung segment with a mucus plug and 27% have more than four lung segments with mucus plugs.

Historically, studies of mucolytics, like NAC, have not shown benefit in other obstructive lung diseases, like Chronic Obstructive Pulmonary Disease (COPD). However, utilizing CT mucus scores as a biomarker, investigators believe that mucolytic treatment may prove useful for those with significant mucus impaction.

This is a randomized, double-blind, placebo-controlled phase 4 study of 20% NAC in patients with asthma who also have evidence of mucus in their lungs as determined by CT imaging. Investigators hypothesize that by treating asthmatics, chosen based on the presence of mucus in the airways, with a mucolytic like NAC, will result in an improvement of lung function.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Condition  ICMJE Asthma
Intervention  ICMJE
  • Drug: n-acetylcystine + albuterol
    NAC is a mucolytic drug and Albuterol is a bronchodilator.
    Other Names:
    • Mucomyst
    • NAC
    • n-acetylcystine
  • Drug: 0.9% saline + albuterol
    Normal saline is a placebo agent and Albuterol is a bronchodilator.
    Other Name: Normal saline
Study Arms  ICMJE
  • Experimental: 20% n-acetylcystine (NAC)
    NAC (trade name: Mucomyst) is manufactured by American Regent. The active drug studied here is 20% NAC coadministered with albuterol and delivered via nebulizer three times per day for fourteen days.
    Intervention: Drug: n-acetylcystine + albuterol
  • Placebo Comparator: 0.9% saline
    Normal saline will be coadministered with albuterol as the placebo agent via a nebulizer three times per day for fourteen days.
    Intervention: Drug: 0.9% saline + albuterol
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Not yet recruiting
Estimated Enrollment  ICMJE
 (submitted: January 28, 2019)
30
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE March 2022
Estimated Primary Completion Date March 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 80 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Ariana Baum, BA 415-514-1539 ariana.baum@ucsf.edu
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03822637
Other Study ID Numbers  ICMJE 18-26680
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party University of California, San Francisco
Study Sponsor  ICMJE University of California, San Francisco
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: John Fahy, M.D, M.Sc. University of California, San Francisco
PRS Account University of California, San Francisco
Verification Date January 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP