Study of Expectorant Activity of Oral N-acetylcystein (NAC) in Patients With Stable Chronic Bronchitis
Phase 2
Completed
- Conditions
- Chronic Bronchitis
- Registration Number
- NCT00205647
- Lead Sponsor
- Wake Forest University
- Brief Summary
This is a randonmized, masked, placebo-controlled parallel group, clinical trial to evaluate the effects of three different doses of N-acetyl L-cysteine (NAC) and placebo on patient safety and on physical and transport properties of expectorated sputum. Patient sumptoms, quality of life and exacerbation will also be followed as well as pulmonary function testing and functional exercise capacity. We hypothesized that a prolongeed course of oral NAC favorably affects the morbidity of chronic bronchitis, particularly the incidence of acute exacerbations.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 240
Inclusion Criteria
- Smokers (past or current,20 pack years) with diagnosis of chronic bronchitis
- expectorate sputum daily
- FEV1 of 40-70%
- understand and fill out questionnaire daily
Exclusion Criteria
- other investigational within 30 days
- change in smoking habit within 6 months
- pulmonary diagnosis other that chronic bronchitis
- significant renal, cardiac, hepatic or endocrine diseases
- psychiatric disorder or evidence of alcoholism or drug abuse within year
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method Acute exacerbations Clinical assessments
- Secondary Outcome Measures
Name Time Method Functional exercise capacity Relationship between mucus physical and transport properties
Trial Locations
- Locations (1)
Wake Forest University Health Sciences
🇺🇸Winston-Salem, North Carolina, United States