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

Tracking Information

First Received Date ^ICMJE

September 13, 2005

Last Updated Date

January 4, 2006

Start Date ^ICMJE

January 1997

Primary Completion Date

Not Provided

Current Primary Outcome Measures ^ICMJE

Acute exacerbations
Clinical assessments

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT00205647 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Functional exercise capacity
Relationship between mucus physical and transport properties

Original Secondary Outcome Measures ^ICMJE

Same as current

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

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

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.

Detailed Description

Not Provided

Study Type ^ICMJE

Interventional

Study Phase

Phase 2

Study Design ^ICMJE

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

Condition ^ICMJE

Chronic Bronchitis

Intervention ^ICMJE

Drug: Oral N-acetycystein (NAC)

Study Arm (s)

Not Provided

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

240

Completion Date

March 2000

Primary Completion Date

Not Provided

Eligibility Criteria ^ICMJE

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

Gender

Both

Ages

18 Years to 75 Years

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

United States

Administrative Information

NCT Number ^ICMJE

NCT00205647

Other Study ID Numbers ^ICMJE

ZAM-13343

Has Data Monitoring Committee

Not Provided

Responsible Party

Not Provided

Study Sponsor ^ICMJE

Wake Forest University

Collaborators ^ICMJE

Zambon SpA

Investigators ^ICMJE

Principal Investigator:

Bruce K Rubin, MEng,MD,MBA

Wake Forest University

Information Provided By

Wake Forest University

Verification Date

March 2000

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

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