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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 University
ClinicalTrials.gov Identifier:
NCT00205647
First received: September 13, 2005
Last updated: January 4, 2006
Last verified: March 2000
History of Changes
  Purpose

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:

U.S. FDA Resources

Further study details as provided by Wake Forest University:

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
  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00205647

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

No publications provided

ClinicalTrials.gov 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 University:
Chronic Bronchitis
N-acetylcysteine (NAC)
Quality of Life
Mucus

Additional relevant MeSH terms:
Bronchitis
Bronchitis, Chronic
Acute Disease
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Tract Infections
 Disease Attributes
Pathologic Processes
Pulmonary Disease, Chronic Obstructive
Expectorants
Respiratory System Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 21, 2013