Chronic Obstructive Pulmonary Bronchitis MedDRA version: 9.1 Level: LLT Classification code 10029978 Term: Obstructive chronic bronchitis with acute exacerbation
Conditions
Interventions
Trade Name: FLUIMUCIL 600
Pharmaceutical Form: Effervescent tablet
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 600-
Pharmaceutical form of the placebo: Efferve
Sponsors
ZAMBON GROUP
Eligibility
Sex/Gender
All
Inclusion criteria
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
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To show that both treatments with NAC 600 mg/day and NAC 1,200 mg/day exhibit a superior efficacy, in terms of reduction of the composite score Breathlessness, Cough and Sputum Scale versus placebo in patients with COPD exacerbation.;Secondary Objective: 1.To evaluate a dose escalation effect for doses of 600 and 1,200 mg/day of NAC in reducing composite score in patients with COPD exacerbation. In the treatment groups 2.To compare the time for remission of symptoms and the number of recovered patients. 3.To compare the number of sleep awakenings due to cough. 4.to compare the consumptions of medications prescribed for COPD exacerbation 5.To compare the number of patients with hospitalizations for COPD. 6.To compare the change from baseline of FEV1 and FEV6. 7.To compare the change from baseline of the patient s well-being. 8.To evaluate the safety of the treatment with NAC 600 mg/day and NAC 1,200 mg/day in terms of incidence of adverse events. 9.To evaluate the global efficacy and tolerability of the treatment with NAC 600 mg/day and NAC 1,200 mg/day.;Primary end point(s): The primary efficacy endpoint is the change from baseline in the composite score at day 5 of treatment, by summing up single breathlessness, cough and sputum scores, assessed daily by the patient on a 5-point scale NAC doses 600 mg/day and 1200mg/day are compared to placebo | — |
Countries
Italy
Outcome results
None listed