Sub-lingual administration of a Polyvalent Mechanical Bacterial Lysate (PMBL) in patients with Moderate or Severe and very Severe Chronic Obstructive Pulmonary Disease (COPD) according to GOLD classification: a multicenter, international, double blind, randomized, controlled, phase IV study. - Advanced Immunological Approach in COPD Exacerbatio

• Conditions: MedDRA version: 9.1Level: LLTClassification code 10029978Term: Obstructive chronic bronchitis with acute exacerbation; Patients with documented moderate, severe and very severe COPD.

• Registration Number: EUCTR2007-000006-67-IT
• Lead Sponsor: ALLEMAND PHARMA INTERNATIONA

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2009-06-08
• Last Update Posted: 19 March 2012

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 258

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 <1.5 times upper limit of laboratory normal (ULN).
- Total serum bilirubin <1.5 times ULN.
- ALAT or ASAT <5 times ULN.
- Alkaline phosphatase <5 times ULN.
- Gammaglutamyltransferase (GGT) <5 times ULN.
- LDH <5 times ULN.
- Before patient randomization, written informed consent must be given according to ICH/GCP, and national/local regulations
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

- 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.

Study & Design

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