Completed

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

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What is being tested

Data Collection

Who is being recruted

Bronchial Diseases+10

+ Bronchitis

+ Chronic Disease

From 18 to 75 Years
+9 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Treatment Study

Phase 2
Interventional
Study Start: January 1997
See protocol details

Summary

Principal SponsorWake Forest University
Last updated: January 27, 2026
Sourced from a government-validated database.Claim as a partner

Study start date: January 1, 1997

Actual date on which the first participant was enrolled.

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.

Official TitleA Phase II Multicenter Efficacy, Safety and Dose-Effect Study of the Expectorant Activity of Oral N-acetylcystein (NAC) in Patients With Stable, Chronic Bronchitis
NCT00205647
Principal SponsorWake Forest University
Last updated: January 27, 2026
Sourced from a government-validated database.Claim as a partner

Protocol

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

240 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

From 18 to 75 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Bronchial DiseasesBronchitisChronic DiseaseInfectionsLung DiseasesLung Diseases, ObstructivePathologic ProcessesRespiratory Tract DiseasesRespiratory Tract InfectionsPathological Conditions, Signs and SymptomsDisease AttributesPulmonary Disease, Chronic ObstructiveBronchitis, Chronic

Criteria

4 inclusion criteria required to participate
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
5 exclusion criteria prevent from participating
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
Show More Criteria

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Study Objectives

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

Suspended

Wake Forest University Health Sciences

Winston-Salem, United StatesOpen Wake Forest University Health Sciences in Google Maps
CompletedOne Study Center