Back to resultsStudy of Expectorant Activity of Oral N-acetylcystein (NAC) in Patients With Stable Chronic Bronchitis
Primary Purpose
Chronic Bronchitis
Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Oral N-acetycystein (NAC)
Sponsored by
About this trial
This is an interventional treatment trial for Chronic Bronchitis focused on measuring Chronic Bronchitis, N-acetylcysteine (NAC), Quality of Life, Mucus
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
Sites / Locations
- Wake Forest University Health Sciences
Outcomes
Primary Outcome Measures
Acute exacerbations
Clinical assessments
Secondary Outcome Measures
Functional exercise capacity
Relationship between mucus physical and transport properties
Full Information
NCT ID
NCT00205647
First Posted
September 13, 2005
Last Updated
November 1, 2017
Sponsor
Wake Forest University
Collaborators
Zambon SpA
1. Study Identification
Unique Protocol Identification Number
NCT00205647
Brief Title
Study of Expectorant Activity of Oral N-acetylcystein (NAC) in Patients With Stable Chronic Bronchitis
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 Type
Interventional
2. Study Status
Record Verification Date
March 2000
Overall Recruitment Status
Completed
Study Start Date
January 1997 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
March 2000 (undefined)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Wake Forest University
Collaborators
Zambon SpA
4. Oversight
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Bronchitis
Keywords
Chronic Bronchitis, N-acetylcysteine (NAC), Quality of Life, Mucus
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
Double
Allocation
Randomized
Enrollment
240 (false)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
Oral N-acetycystein (NAC)
Primary Outcome Measure Information:
Title
Acute exacerbations
Title
Clinical assessments
Secondary Outcome Measure Information:
Title
Functional exercise capacity
Title
Relationship between mucus physical and transport properties
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Bruce K Rubin, MEng,MD,MBA
Organizational Affiliation
Wake Forest University Health Sciences
Official's Role
Principal Investigator
Facility Information:
Facility Name
Wake Forest University Health Sciences
City
Winston-Salem
State/Province
North Carolina
ZIP/Postal Code
27157
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Study of Expectorant Activity of Oral N-acetylcystein (NAC) in Patients With Stable Chronic Bronchitis
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