Study of Expectorant Activity of Oral N-acetylcystein (NAC) in Patients With Stable Chronic Bronchitis
| Status: | Completed |
|---|---|
| Conditions: | Bronchitis, Other Indications |
| Therapuetic Areas: | Pulmonary / Respiratory Diseases, Other |
| Healthy: | No |
| Age Range: | 18 - 75 |
| Updated: | 11/8/2017 |
| Start Date: | January 1997 |
| End Date: | March 2000 |
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
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.
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.
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
We found this trial at
1
site
1 Medical Center Blvd
Winston-Salem, North Carolina 27157
Winston-Salem, North Carolina 27157
336-716-2011
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