Clinical Trial: Study of Expectorant Activity of Oral N-Acetylcystein (NAC) in Patients With Stable Chronic Bronchitis
Study Status: Completed
Recruit Status: Completed
Study Type: Interventional
Official Title: 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
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 Summary:
Sponsor: Wake Forest University
Current Primary Outcome:
- Acute exacerbations
- Clinical assessments
Original Primary Outcome: Same as current
Current Secondary Outcome:
- Functional exercise capacity
- Relationship between mucus physical and transport properties
Original Secondary Outcome: Same as current
Information By: Wake Forest University Health Sciences
Dates:
Date Received: September 13, 2005
Date Started: January 1997
Date Completion: March 2000
Last Updated: January 4, 2006
Last Verified: March 2000
