A RANDOMIZED, DOUBLE-BLIND, PLACEBO CONTROLLED, PARALLEL GROUPS STUDY ON EFFICACY AND SAFETY OF NAC 600 MG DAILY AND NAC 1200 MG DAILY AS MUCOLYTIC AGENT IN THE TREATMENT OF CHRONIC OBSTRUCTIVE PULMONARY DISEASE COPD EXACERBATION - ND

• Conditions: Chronic Obstructive Pulmonary Bronchitis; MedDRA version: 9.1Level: LLTClassification code 10029978Term: Obstructive chronic bronchitis with acute exacerbation

• Registration Number: EUCTR2006-004048-21-IT
• Lead Sponsor: ZAMBON GROUP

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2007-02-05
• Last Update Posted: 19 March 2012

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

Outpatients, male or female, aged 40 or over. Patients with diagnosis of COPD according to ATS/ERS guidelines, documented within one year prior to randomization. Patients with a clinical diagnosis of exacerbation according to Anthonisen s criteria who, at the screening visit, are classified as moderate or severe according to ATS/ERS COPD guidelines. -Moderate COPD GOLD stage II FEV1/FVC 70 and 50 8804;FEV1 80 . -Severe COPD GOLD stage III FEV1/FVC 70 and 30 8804;FEV1 50 . Patients with BCSS cumulative score 8805;5 at the screening visit
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

Pregnant or lactating women, or women of childbearing age not using an acceptable method of contraception surgical sterilization, or practising an acceptable method of birth control such as oral hormonal contraceptives or Intrauterine Device . Patients requiring mechanical airway management. Previous 2 weeks or concomitant treatments with any systemic or inhaled antibiotic, systemic corticosteroids, expectorants, mucolytics, cough suppressant, antioxidants. Patients classified, at screening visit -Mild COPD GOLD stage I FEV1/FVC 70 and FEV1 8805;80 -Very severe COPD GOLD stage IV FEV1/FVC 70 and FEV1 30 Hospitalized patients and patients from institutional care facilities. Patients with a known diagnosis of bronchial asthma, cystic fibrosis, active pulmonary tuberculosis, pneumonia, bronchial pneumonia, bronchiectasia, lung cancer or lung metastases, other progressively fatal disease, or life expectancy less than three months. Patients with severe cardiovascular diseases such as NYHA class III or IV congestive heart failure or history of stroke, severe neurological or any other disease interfering with study results and the compliance with study protocol. Immuno-compromised patients. Phenylketonuria due to the presence of aspartame in the study product. Patients with suspected or known hypersensitivity to the study product. Patients known to have conditions affecting study drug absorption or documented active ulcer within the last three years or severely impaired hepatic or renal function.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified