Clinical Trial of NAC in Asthma (CONA)
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|ClinicalTrials.gov Identifier: NCT02605824|
Recruitment Status : Terminated (The study was closed after we determined that this albuterol/NAC regimen may be associated with excessive bronchoconstriction.)
First Posted : November 16, 2015
Results First Posted : August 20, 2019
Last Update Posted : August 20, 2019
|Condition or disease||Intervention/treatment||Phase|
|Asthma||Drug: n-acetylcystine Drug: 0.9% saline||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 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)|
|Actual Enrollment :||1 participants|
|Intervention Model:||Crossover Assignment|
|Masking:||Triple (Participant, Care Provider, Investigator)|
|Official Title:||Clinical Trial of NAC in Asthma|
|Actual Study Start Date :||March 2016|
|Actual Primary Completion Date :||December 2017|
|Actual Study Completion Date :||December 2017|
Experimental: 20% n-acetylcystine (NAC)
NAC (trade name: Mucomyst) is manufactured by American Regent. The active drug studied here is 20% NAC delivered via nebulizer three times per day for seven days.
NAC is a mucolytic drug.
Placebo Comparator: 0.9% saline
Normal saline will be administered as the placebo agent via a nebulizer three times per day for seven days.
Drug: 0.9% saline
Normal saline is a placebo agent.
Other Name: Normal saline
- Change in Post-bronchodilator FEV1 (L) [ Time Frame: 7 days ]This is a measure of forced expiratory volume measured in one second, following the administration of 4 puffs of albuterol. This outcome will compare the change in post-bronchodilator FEV1 (L) both before and after treatment.
- Change CT Mucus Score [ Time Frame: 7 days ]The CT Mucus Score describes the number of segments of the lungs that are impacted by mucus. This outcome will compare the change in CT mucus score both at baseline and following each treatment period.
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): NCT02605824
|United States, California|
|UCSF Airway Clinical Research Center|
|San Francisco, California, United States, 94143|
|Principal Investigator:||John V Fahy, MD, MSc||University of California, San Francisco|