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

November 1, 2017 updated by: Wake Forest University

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment

240

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • North Carolina
      • Winston-Salem, North Carolina, United States, 27157
        • Wake Forest University Health Sciences

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years to 73 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Acute exacerbations
Clinical assessments

Secondary Outcome Measures

Outcome Measure
Functional exercise capacity
Relationship between mucus physical and transport properties

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Wake Forest University

Collaborators

Zambon SpA

Investigators

  • Principal Investigator: Bruce K Rubin, MEng,MD,MBA, Wake Forest University Health Sciences

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 1997

Study Completion

March 1, 2000

Study Registration Dates

First Submitted

September 13, 2005

First Submitted That Met QC Criteria

September 13, 2005

First Posted (Estimate)

September 20, 2005

Study Record Updates

Last Update Posted (Actual)

November 6, 2017

Last Update Submitted That Met QC Criteria

November 1, 2017

Last Verified

March 1, 2000

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ZAM-13343

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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