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

NCT00205647 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 240

Last updated 2017-11-06

No results posted yet for this study

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.

Conditions

  • Chronic Bronchitis

Interventions

DRUG

Oral N-acetycystein (NAC)

Sponsors & Collaborators

  • Zambon SpA

    collaborator INDUSTRY

  • Wake Forest University

    lead OTHER

Principal Investigators

  • Bruce K Rubin, MEng,MD,MBA · Wake Forest University Health Sciences

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
1997-01-31
Completion
2000-03-31

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00205647 on ClinicalTrials.gov