Clinical Trial of NAC in Asthma

• Status: Terminated
• Trial end date: 2017-12-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of California, San Francisco
• Treatments: Acetylcysteine; N-monoacetylcystine

Criteria

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