Study 8 of 147 for search of: "Bronchitis"
Previous Study Return to Search Results Next Study

  Full Text View  
  Tabular View  
  Contacts and Locations  
  No Study Results Posted  
  Related Studies  
Study of Expectorant Activity of Oral N-Acetylcystein (NAC) in Patients With Stable Chronic Bronchitis
This study has been completed.
Sponsors and Collaborators: Wake Forest University
Zambon SpA
Information provided by: Wake Forest University
ClinicalTrials.gov Identifier: NCT00205647
  Purpose

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.


Condition Intervention Phase
Chronic Bronchitis
Drug: Oral N-acetycystein (NAC)
Phase II

MedlinePlus related topics: Bronchitis Exercise and Physical Fitness
Drug Information available for: Acetylcysteine
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study
Official Title: 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

Further study details as provided by Wake Forest University:

Primary Outcome Measures:
  • Acute exacerbations
  • Clinical assessments

Secondary Outcome Measures:
  • Functional exercise capacity
  • Relationship between mucus physical and transport properties

Estimated Enrollment: 240
Study Start Date: January 1997
Estimated Study Completion Date: March 2000
  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00205647

Locations
United States, North Carolina
Wake Forest University Health Sciences
Winston Salem, North Carolina, United States, 27157
Sponsors and Collaborators
Wake Forest University
Zambon SpA
Investigators
Principal Investigator: Bruce K Rubin, MEng,MD,MBA Wake Forest University
  More Information

Study ID Numbers: ZAM-13343
Study First Received: September 13, 2005
Last Updated: January 4, 2006
ClinicalTrials.gov Identifier: NCT00205647  
Health Authority: United States: Institutional Review Board

Keywords provided by Wake Forest University:
Chronic Bronchitis
N-acetylcysteine (NAC)
Quality of Life
Mucus

Study placed in the following topic categories:
Acute Disease
Bronchitis, Chronic
Lung Diseases, Obstructive
Respiratory Tract Infections
Respiratory Tract Diseases
Lung Diseases
Acetylcysteine
Quality of Life
Bronchitis
N-monoacetylcystine
Pulmonary Disease, Chronic Obstructive

Additional relevant MeSH terms:
Disease Attributes
Pathologic Processes
Bronchial Diseases

ClinicalTrials.gov processed this record on January 16, 2009