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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

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.

Condition or disease Intervention/treatment Phase
Asthma Drug: N-acetylcysteine Phase 4

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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
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
Official Title: Inpatient Clinical Trial of NAC
Actual Study Start Date : July 6, 2018
Estimated Primary Completion Date : May 2020
Estimated Study Completion Date : May 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Asthma

Arm Intervention/treatment
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.
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.




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03581084


Contacts
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Contact: Ariana Baum 415-514-1539 ariana.baum@ucsf.edu

Locations
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United States, California
University of California, San Francisco Recruiting
San Francisco, California, United States, 94143
Contact: John V Fahy, M.D. M.Sc    415-502-4849      
Sponsors and Collaborators
University of California, San Francisco
National Institutes of Health (NIH)
Investigators
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Principal Investigator: John Fahy, M.D, M.Sc. University of California, San Francisco

Publications of Results:
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Responsible Party: University of California, San Francisco
ClinicalTrials.gov Identifier: NCT03581084     History of Changes
Other Study ID Numbers: 17-24231
First Posted: July 10, 2018    Key Record Dates
Last Update Posted: July 11, 2018
Last Verified: July 2018

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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

Additional relevant MeSH terms:
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Acetylcysteine
N-monoacetylcystine
Antiviral Agents
Anti-Infective Agents
Expectorants
Respiratory System Agents
Free Radical Scavengers
Antioxidants
Molecular Mechanisms of Pharmacological Action
Protective Agents
Physiological Effects of Drugs
Antidotes