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
|Condition or disease||Intervention/treatment||Phase|
|Asthma||Drug: n-acetylcystine + albuterol Drug: 0.9% saline + albuterol||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 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 :||Interventional (Clinical Trial)|
|Estimated Enrollment :||30 participants|
|Intervention Model:||Crossover Assignment|
|Masking:||Triple (Participant, Care Provider, Investigator)|
|Official Title:||The Effect of NAC on Lung Function and CT Mucus Score|
|Estimated Study Start Date :||March 2019|
|Estimated Primary Completion Date :||March 2021|
|Estimated Study Completion Date :||March 2022|
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.
Drug: n-acetylcystine + albuterol
NAC is a mucolytic drug and Albuterol is a bronchodilator.
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.
Drug: 0.9% saline + albuterol
Normal saline is a placebo agent and Albuterol is a bronchodilator.
Other Name: Normal saline
- 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).
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): NCT03822637
|Contact: Ariana Baum, BAemail@example.com|
|United States, California|
|UCSF Airway Clinical Research Center|
|San Francisco, California, United States, 94143|
|Principal Investigator:||John Fahy, M.D, M.Sc.||University of California, San Francisco|