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Clinical Trials/NCT00205647
NCT00205647
Completed
Phase 2

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

Wake Forest University1 site in 1 country240 target enrollmentJanuary 1997

Overview

Phase
Phase 2
Intervention
Not specified
Conditions
Chronic Bronchitis
Sponsor
Wake Forest University
Enrollment
240
Locations
1
Primary Endpoint
Acute exacerbations
Status
Completed
Last Updated
8 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
January 1997
End Date
March 2000
Last Updated
8 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

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

Outcomes

Primary Outcomes

Acute exacerbations

Clinical assessments

Secondary Outcomes

  • Functional exercise capacity
  • Relationship between mucus physical and transport properties

Study Sites (1)

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