Clinical Trial of NAC in Asthma
Stopped early · Phase 4 · Has a placebo group
Conditions studied: Asthma
In brief
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.
Key facts
- Study ID
- NCT02605824
- Run by
- University of California, San Francisco
- People needed
- 1
- Starts
- 2016-03-01
- Expected to finish
- 2017-12-01
- Last updated by the study team
- 2019-08-20
Who can join
Age: 18 and older, up to 70. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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.
You may not qualify if…
- 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
Where it is running
- UCSF Airway Clinical Research Center — San Francisco, California, United States
Full record on ClinicalTrials.gov
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