Patients with documented moderate, severe and very severe COPD. MedDRA version: 9.1 Level: LLT Classification code 10029978 Term: Obstructive chronic bronchitis with acute exacerbation
Conditions
Interventions
Trade Name: ISMIGEN
Pharmaceutical Form: Tablet
INN or Proposed INN: LISATO BATTERICO POLIVALENTE
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 50-
Pharmaceutica
Sponsors
LALLEMAND PHARMA INTERNATIONAL
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - Patients with documented moderate, severe and very severe COPD - Age greater than or equal to 40 years. - Female patient must be non-lactating and of non-childbearing potential, surgically sterile, or using effective contraception. - Patients must have WHO performance status of 0, 1 or 2. - Patients must have adequate hematological, renal and liver function as defined by laboratory values below performed within 14 days, inclusive, prior to study randomization. - Smokers, ex-smokers can be included but the smoking status is acquired and accurately recorded - Absolute neutrophil count (ANC) ≥ 2.0 x 109/l. - Platelet count ≥ 100 x 109/l. - Hemoglobin ≥ 10 g/dl (> 6.2 mmol/l). - Urea and serum creatinine =65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: - Patients who had received any prior antineoplastic drug therapy or immunosuppressive drugs. - Patients under continuous treatment with systemic steroids. - Presence of severe cardiac disease including uncontrolled angina pectoris and myocardial infarction within 6 months, uncontrolled high blood pressure. - Presence of severe respiratory disease as identified from spirometry and/or chest X ray. - Presence of any other uncontrolled severe medical condition including active gastroduodenal ulcer, alcohol disorders ( hepatitis, Korsakoff syndrome..), diabetes, active or uncontrolled infection, evolutive intracranial hypertension? - Patients pregnant or nursing at the beginning of the study. - Presence of any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule; those conditions should be discussed with the patient before registration in the trial.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: dimostration of the clinical efficacy of Ismigen in patients with moderate, severe and very severe COPD according to GOLD classification, in terms of reduction of the number of exacerbations in 12 mounth observation period.;Secondary Objective: - To evaluate the effect of Ismigen on the interval between each exacerbation. - To evaluate the effect of Ismigen on symptoms (fever, dyspnoea). - To verify whether Ismigen is able to reduce the use of other drugs (antibiotics, antinflammatory drugs, bronchodilators, mucolytics, etc.) in patients with documented M/S/VS-COPD. -To verify whether Ismigen is able to reduce the number of days of absence from work in patients with documented M/S/VS-COPD. -To evaluate the effect of Ismigen on the number and duration of hospitalizations. - To study the potential toxicity of the treatment. - To evaluate the impact on quality of life assessed with a generic health survey (SF-12) and a specific (CCIQ) instrument.;Primary end point(s): Number of exacerbation in a 12 mounth observation period. | — |
Countries
Italy
Outcome results
None listed