The Influence of Polyvalent Mechanical Bacterial Lysate (ISMIGEN®) on Clinical Course of Asthma and Related Immunological parameters in Asthmatic Children (EOLIA Study): Randomized, Double Blind, Placebo-Controlled, Multicentre, Parallel-Group Study

• Conditions: IgE-dependent asthma (diagnosis of asthma according to the GINA definition) in a paediatric population (6 thru 16 years old); MedDRA version: 17.0Level: LLTClassification code 10001705Term: Allergic asthmaSystem Organ Class: 100000004855; Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]

• Registration Number: EUCTR2013-000737-12-PL
• Lead Sponsor: allemand Pharma International AG

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2013-06-11
• Last Update Posted: 28 September 2015

Recruitment & Eligibility

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

Inclusion Criteria

1. Children of both genders aged 6 to 16 years.
2. Allergic asthma diagnosis with at least one perennial allergen according to the Global Strategy for Asthma Management and Prevention (GINA 2012 guidelines) prior to screening visit.
3.Patient shows clinical characteristics of partly controlled or uncontrolled asthma according to GINA 2012.
4. Already treated with SABA prn and ICS or ICS + LABA during the previous 3 months.
5. Patient shows asIgE against HDM = class 2 or positive skin prick test or RAST for at least one perennial allergen.
6. Patient who had at least 2 exacerbations of asthma within the 12-mo period before V1.
7. Patient not treated with Polyvalent Mechanical Bacterial Lysate (Ismigen®) within the previous 6 months prior to V1.
Are the trial subjects under 18? yes
Number of subjects for this age range: 150
F.1.2 Adults (18-64 years) no
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

1. Patient received mechanical or any other bacterial lysate immunostimulation within the previous 6 months before V1.
2. Patient received oral/subcutaneous allergen-immunotherapy within the previous 6 months before V1.
3. History of near fatal asthma (e.g. brittle asthma, hospitalization for asthma exacerbation in Intensive Care Unit).
4. Pregnant or breastfeeding woman.

Study & Design

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