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Inpatient Clinical Trial of NAC (ICON)

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ClinicalTrials.gov Identifier: NCT03581084
Recruitment Status : Recruiting
First Posted : July 10, 2018
Last Update Posted : July 11, 2018
Sponsor:
Collaborator:
National Institutes of Health (NIH)
Information provided by (Responsible Party):
University of California, San Francisco

Tracking Information
First Submitted Date  ICMJE April 12, 2018
First Posted Date  ICMJE July 10, 2018
Last Update Posted Date July 11, 2018
Actual Study Start Date  ICMJE July 6, 2018
Estimated Primary Completion Date May 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 9, 2018)
Forced Expiratory Volume in One Second (FEV1) measurement [ Time Frame: From the start to the end of the one week treatment period ]
Post-treatment FEV1 will be compared to pre-treatment baseline values.
Original Primary Outcome Measures  ICMJE
 (submitted: July 6, 2018)
FEV1 [ Time Frame: From the start to the end of the one week treatment period ]
Post-treatment FEV1 will be compared to pre-treatment baseline values.
Change History Complete list of historical versions of study NCT03581084 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: July 9, 2018)
Computed Tomography (CT) scan mucus score [ Time Frame: From the start of the one week treatment period to the three month follow-up ]
Post-treatment CT mucus scores will be compared to pre-treatment CT mucus score
Original Secondary Outcome Measures  ICMJE
 (submitted: July 6, 2018)
CT mucus score [ Time Frame: From the start of the one week treatment period to the three month follow-up ]
Post-treatment mucus scores will be compared to pre-treatment mucus score.
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Inpatient Clinical Trial of NAC
Official Title  ICMJE Inpatient Clinical Trial of NAC
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.
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 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 single-arm study of participants 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 Intervention Model: Single Group Assignment
Intervention Model Description:
This is a single-arm study which means all study participants will receive the same treatment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Asthma
Intervention  ICMJE Drug: N-acetylcysteine
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.
Study Arms  ICMJE Experimental: N-acetylcysteine
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.
Intervention: Drug: N-acetylcysteine
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 Recruiting
Estimated Enrollment  ICMJE
 (submitted: July 6, 2018)
30
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE May 2021
Estimated Primary Completion Date May 2020   (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 ATS criteria
  4. Physiological evidence of airflow obstruction (FEV1 bronchodilator reversibility of ≥ 12% or hyperreactivity to methacholine reflected by a methacholine 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 > 3

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. Current participation in an investigational drug trial
  5. 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
  6. Unwillingness to follow study procedures
  7. History of allergy or intolerance to study drug
  8. 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 415-514-1539 ariana.baum@ucsf.edu
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03581084
Other Study ID Numbers  ICMJE 17-24231
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 Not Provided
Responsible Party University of California, San Francisco
Study Sponsor  ICMJE University of California, San Francisco
Collaborators  ICMJE National Institutes of Health (NIH)
Investigators  ICMJE
Principal Investigator: John Fahy, M.D, M.Sc. University of California, San Francisco
PRS Account University of California, San Francisco
Verification Date July 2018

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