Clinical Trial of NAC in Asthma
| Status: | Terminated |
|---|---|
| Conditions: | Asthma |
| Therapuetic Areas: | Pulmonary / Respiratory Diseases |
| Healthy: | No |
| Age Range: | 18 - 70 |
| Updated: | 10/21/2018 |
| Start Date: | March 2016 |
| End Date: | December 2017 |
This study evaluates 20% n-acetylcystine (NAC) in the treatment of moderate-to-severe asthma
that is complicated by mucus in the airway, as determined by CT imaging. The study is a
crossover design, which means that half the study participants will get 20% NAC in the first
7-day treatment period and placebo in the next 7-day treatment period; and the other half
will get placebo in the first 7-day treatment period and 20% NAC in the next 7-day treatment
period.
that is complicated by mucus in the airway, as determined by CT imaging. The study is a
crossover design, which means that half the study participants will get 20% NAC in the first
7-day treatment period and placebo in the next 7-day treatment period; and the other half
will get placebo in the first 7-day treatment period and 20% NAC in the next 7-day treatment
period.
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.
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.
Inclusion Criteria:
- Able to perform reproducible spirometry according to ATS criteria
- Clinical history consistent with moderate to severe asthma for 1 year or greater.
- Post-bronchodilator FEV1 <90% of predicted
- Prescription and daily use of inhaled corticosteroid (ICS) equivalent to 240mcg of
beclomethasone or greater and a second asthma controller therapy.
- CT mucus score >3 (determined during the initial screening process, provided the prior
two conditions are met)
- Written informed consent obtained from participant and ability for participant to
comply with the requirements of the study.
Exclusion Criteria:
- Pregnant, breastfeeding, or unwilling to practice birth control during participation
in the study.
- 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.
- History of intolerance to study medications.
- Current use of carbamazepine
- Angina which includes a treatment plan with PRN nitroglycerin or nitrites
- Smoking of tobacco or other recreational inhalants in last year and/or >10 pack-year
smoking history
- Current participation in an investigational drug trial Concurrent Medications
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