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

Chronic Bronchitis Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00205647
• Other study ID #: ZAM-13343
• Status: Completed
• Phase: Phase 2
• First received: September 13, 2005
• Last updated: November 1, 2017
• Start date: January 1997
• Est. completion date: March 2000

Study information

• Verified date: March 2000
• Source: Wake Forest University Health Sciences
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 240
• Est. completion date: March 2000
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Acute Disease
• Bronchitis
• Bronchitis, Chronic
• Chronic Bronchitis

Intervention

Drug:
• Oral N-acetycystein (NAC)

Locations

Country	Name	City	State
United States	Wake Forest University Health Sciences	Winston-Salem	North Carolina

Sponsors (2)

Lead Sponsor	Collaborator
Wake Forest University	Zambon SpA

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Acute exacerbations
Primary	Clinical assessments
Secondary	Functional exercise capacity
Secondary	Relationship between mucus physical and transport properties