Study of Expectorant Activity of Oral N-acetylcystein (NAC) in Patients With Stable Chronic Bronchitis

A Phase II Multicenter Efficacy, Safety and Dose-Effect Study of the Expectorant Activity of Oral N-acetylcystein (NAC) in Patients With Stable, Chronic Bronchitis

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.

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