Chronic Bronchitis
Conditions
Keywords
Chronic Bronchitis, N-acetylcysteine (NAC), Quality of Life, Mucus
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.
Interventions
DRUGOral N-acetycystein (NAC)
Sponsors
Zambon SpA
Wake Forest University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Acute exacerbations | — |
| Clinical assessments | — |
Secondary
| Measure | Time frame |
|---|---|
| Functional exercise capacity | — |
| Relationship between mucus physical and transport properties | — |
Countries
United States
Outcome results
None listed