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

NCT ID: NCT00205647

Last Updated: 2017-11-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

240 participants

Study Classification

INTERVENTIONAL

Study Start Date

1997-01-31

Study Completion Date

2000-03-31

Brief Summary

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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

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Conditions

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Chronic Bronchitis

Keywords

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Chronic Bronchitis N-acetylcysteine (NAC) Quality of Life Mucus

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Interventions

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Oral N-acetycystein (NAC)

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Zambon SpA

INDUSTRY

Sponsor Role collaborator

Wake Forest University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Bruce K Rubin, MEng,MD,MBA

Role: PRINCIPAL_INVESTIGATOR

Wake Forest University Health Sciences

Locations

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Wake Forest University Health Sciences

Winston-Salem, North Carolina, United States

Site Status

Countries

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United States

Other Identifiers

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ZAM-13343

Identifier Type: -

Identifier Source: org_study_id