IgE-dependent asthma (diagnosis of asthma according to the GINA definition) in a paediatric population (6 thru 16 years old) MedDRA version: 17.0 Level: LLT Classification code 10001705 Term: Allergic asthma System Organ Class: 100000004855
Conditions
Interventions
Trade Name: ISMIGEN
Pharmaceutical Form: Sublingual tablet
Pharmaceutical form of the placebo: Sublingual tablet
Route of administration of the placebo: Sublingual use
Sponsors
Lallemand Pharma International AG
Eligibility
Sex/Gender
All
Inclusion criteria
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
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To demonstrate the improvement versus placebo of the asthma control level as measured by the mean ACT (Asthma Control Test) score after administration of a Polyvalent Mechanical Bacterial Lysate (PMBL - Ismigen®) as add-on to routine asthma treatment;Secondary Objective: - To demonstrate the decrease in number of asthma exacerbations, and increase in time to first asthma exacerbation after administration of Ismigen®. - To demonstrate the decrease in number of respiratory tract infections during the Ismigen® treatment period and a 6 months follow-up after treatment in comparison with the pre-treatment period (according to medical history). - To demonstrate specific changes in a panel of immunological parameters in a biology subset of patients. - To demonstrate an improvement in the quality of life of patients.;Primary end point(s): The main criterion is defined as the target improvement in asthma control level as measured by the mean ACT (Asthma Control Test) or P-ACT (Pediatric Asthma Control Test) score at 3 months.;Timepoint(s) of evaluation of this end point: The product dependent progressive improvement in ACT/P-ACT score will be recorded throughout the study period at 3-month intervals during the study (at end of treatment and during a 6-month follow-up). | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): 1. The number of respiratory infections occurring during the 3-mo Ismigen® treatment and the 6-mo follow-up after treatment. 2. The time to first mild or severe asthma exacerbation will be reported. 3. Standardized mean daily dose of ICS used during the whole study. 4. The frequency of short acting beta-2 agonists use as rescue medication will be reported throughout the study. 5. Blood levels of immunological parameters. 6. Quality of life endpoints: the PAQLQ (Paediatric Asthma Quality of Life Questionnaire and PACQLQ (Paediatric Asthma Caregivers Quality of Life Questionnaire) will be scored at the end of the study in comparison with the baseline prior to treatment 7. The cumulative number of days with respiratory tract infections will be reported during the whole study. 8. The number of lost school days due to respiratory infections as well as to asthma exacerbations will be reported during the whole study period.;Timepoint(s) of evaluation of this end point: These end-points will be evaluated throughout the study period at 3-month intervals during the study (at end of treatment and during a 6-month follow-up). Item #5 will e assessed at baseline, 3 weeks and 3 months. Item #6 will be evaluated at the end of study only in comparison with baseline. | — |
Countries
Poland
Contacts
Public ContactMarzanna Tomicka
ClinStart
Outcome results
None listed