Trial | NCT00205647  Report issue

Title

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

  • Phase

    Phase 2

  • Study Type

    Interventional

  • Status

    Completed No Results Posted

  • Study Participants

    240
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 Started
Jan 31
1997
Study Completion
Mar 31
2000
Last Update
Nov 06
2017

Drug Oral N-acetycystein (NAC)

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
No Results Posted