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

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

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.

Condition Intervention Phase
Chronic Bronchitis
Drug: Oral N-acetycystein (NAC)
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
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

Resource links provided by NLM:

Further study details as provided by Wake Forest School of Medicine:

Primary Outcome Measures:
  • Acute exacerbations
  • Clinical assessments

Secondary Outcome Measures:
  • Functional exercise capacity
  • Relationship between mucus physical and transport properties

Estimated Enrollment: 240
Study Start Date: January 1997
Estimated Study Completion Date: March 2000

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

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
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Please refer to this study by its identifier: NCT00205647

United States, North Carolina
Wake Forest University Health Sciences
Winston Salem, North Carolina, United States, 27157
Sponsors and Collaborators
Wake Forest University
Zambon SpA
Principal Investigator: Bruce K Rubin, MEng,MD,MBA Wake Forest School of Medicine
  More Information

No publications provided Identifier: NCT00205647     History of Changes
Other Study ID Numbers: ZAM-13343
Study First Received: September 13, 2005
Last Updated: January 4, 2006
Health Authority: United States: Institutional Review Board

Keywords provided by Wake Forest School of Medicine:
Chronic Bronchitis
N-acetylcysteine (NAC)
Quality of Life

Additional relevant MeSH terms:
Bronchitis, Chronic
Bronchial Diseases
Lung Diseases
Lung Diseases, Obstructive
Pulmonary Disease, Chronic Obstructive
Respiratory Tract Diseases
Respiratory Tract Infections
Pharmacologic Actions
Respiratory System Agents
Therapeutic Uses processed this record on October 13, 2015