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Sponsors and Collaborators: |
Wake Forest University Zambon SpA |
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Information provided by: | Wake Forest University |
ClinicalTrials.gov Identifier: | NCT00205647 |
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 |
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Chronic Bronchitis |
Drug: Oral N-acetycystein (NAC) |
Phase II |
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 |
Ages Eligible for Study: | 18 Years to 75 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
United States, North Carolina | |
Wake Forest University Health Sciences | |
Winston Salem, North Carolina, United States, 27157 |
Principal Investigator: | Bruce K Rubin, MEng,MD,MBA | Wake Forest University |
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 |
Chronic Bronchitis N-acetylcysteine (NAC) Quality of Life Mucus |
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 |
Disease Attributes Pathologic Processes Bronchial Diseases |