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Advanced Immunological Approach in COPD Exacerbation

NCT02417649 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 288

Last updated 2015-04-15

No results posted yet for this study

Summary

Chronic obstructive pulmonary disease (COPD) are characterized by frequent relapses, often resulting from common bacterial infections. Enhancing the immune response in these patients may decrease the frequency of these relapses. The use of a mechanic Polyvalent Bacterial Lysate (PMBL, Ismigen, 13 bacterial strains)may enhance the immune response and therefore help significantly to the control of relapse in these patients.

In the current study the effect of the administration of the PBML to patients older than 40 years, with moderate, severe or very severe COPD, in good or discrete physical condition on the number of relapses in an observation period of 12 months. In addition, the effect of the PMBL on the duration of the interval between relapses, on relapse symptoms, on the use of other drugs, on the number of days of absence of work, on the number of hospitalizations and duration thereof and on potential toxicity of the treatment.

Conditions

  • Chronic Obstructive Pulmonary Disease (COPD)

Interventions

BIOLOGICAL

Placebo

1. The placebo will be administered for a period of three months. The first ten days of each month, one tablet per day will be given. The tablet will be melted under the tongue. After the ten day therapy, a twenty day of rest will be provided. Then the second and the third month the administration schedule will be identical. 2. Three months of rest, according to the indications, will be allowed. 3. A second cycle (the same as point 1.) will be performed 4. A second three month rest (according to point 2.) will be provided.

BIOLOGICAL

Ismigen

1. The tablet will be administered for a period of three months. The first ten days of each month, one tablet per day will be given. The tablet will be melted under the tongue. After the ten day therapy, a twenty day of rest will be provided. Then the second and the third month the administration schedule will be identical. 2. Three months of rest, according to the indications, will be allowed. 3. A second cycle (the same as point 1.) will be performed 4. A second three month rest (according to point 2.) will be provided.

Sponsors & Collaborators

  • Sprim Advanced Life Sciences

    collaborator OTHER

  • Lallemand Pharma AG

    lead INDUSTRY

Principal Investigators

  • Giorgio Walter Canonica, Prof. MD · University of Genova, Genova, Italy

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
40 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-09-30
Primary Completion
2013-07-31
Completion
2013-07-31

Countries

  • Italy

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02417649 on ClinicalTrials.gov