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
|Condition or disease||Intervention/treatment||Phase|
|Asthma||Drug: N-acetylcysteine||Phase 4|
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 :||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)|
|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|
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.
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.
- 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.
- 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
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
|Contact: Ariana Baumemail@example.com|
|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|
|Principal Investigator:||John Fahy, M.D, M.Sc.||University of California, San Francisco|