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

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ClinicalTrials.gov Identifier: NCT00205647
Recruitment Status : Completed
First Posted : September 20, 2005
Last Update Posted : November 6, 2017
Zambon SpA
Information provided by (Responsible Party):
Wake Forest University Health Sciences ( Wake Forest University )

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.

Condition or disease Intervention/treatment Phase
Chronic Bronchitis Drug: Oral N-acetycystein (NAC) Phase 2

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 240 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
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
Study Start Date : January 1997
Estimated Study Completion Date : March 2000

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Primary Outcome Measures :
  1. Acute exacerbations
  2. Clinical assessments

Secondary Outcome Measures :
  1. Functional exercise capacity
  2. Relationship between mucus physical and transport properties

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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 University Health Sciences

Responsible Party: Wake Forest University
ClinicalTrials.gov Identifier: NCT00205647     History of Changes
Other Study ID Numbers: ZAM-13343
First Posted: September 20, 2005    Key Record Dates
Last Update Posted: November 6, 2017
Last Verified: March 2000

Keywords provided by Wake Forest University Health Sciences ( Wake Forest University ):
Chronic Bronchitis
N-acetylcysteine (NAC)
Quality of Life

Additional relevant MeSH terms:
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
Respiratory System Agents