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

Phase 2CompletedNCT00205647

Wake Forest University240 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

240

Conditions

Chronic Bronchitis

Interventions

Oral N-acetycystein (NAC)DRUG

Eligibility

Sex: ALLMin age: 18 YearsMax age: 75 Years

Medical Language ↔ Plain English

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

Locations (1)

Wake Forest University Health Sciences

Winston-Salem, North Carolina, United States

Outcomes

Primary Outcomes

Acute exacerbations

Clinical assessments

Secondary Outcomes

Functional exercise capacity

Relationship between mucus physical and transport properties

Data from ClinicalTrials.gov

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