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

Completed · Phase 2

Conditions studied: Chronic Bronchitis

In brief

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.

Key facts

Study ID

NCT00205647

Run by

Wake Forest University

People needed

240

Starts

1997-01-01

Expected to finish

2000-03-01

Last updated by the study team

2017-11-06

Who can join

Age: 18 and older, up to 75. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Wake Forest University Health Sciences — Winston-Salem, North Carolina, United States

Full record on ClinicalTrials.gov

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