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

This study has been completed.
Sponsor:
Collaborator:
Zambon SpA
Information provided by:
Wake Forest School of Medicine
ClinicalTrials.gov Identifier:
NCT00205647
First received: September 13, 2005
Last updated: January 4, 2006
Last verified: March 2000

September 13, 2005
January 4, 2006
January 1997
Not Provided
  • Acute exacerbations
  • Clinical assessments
Same as current
Complete list of historical versions of study NCT00205647 on ClinicalTrials.gov Archive Site
  • Functional exercise capacity
  • Relationship between mucus physical and transport properties
Same as current
Not Provided
Not Provided
 
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.

Not Provided
Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Chronic Bronchitis
Drug: Oral N-acetycystein (NAC)
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
240
March 2000
Not Provided

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
Both
18 Years to 75 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00205647
ZAM-13343
Not Provided
Not Provided
Wake Forest School of Medicine
Zambon SpA
Principal Investigator: Bruce K Rubin, MEng,MD,MBA Wake Forest School of Medicine
Wake Forest School of Medicine
March 2000

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP