Subcutaneous-Sublingual Immunotherapy With Depigmented and Polymerized Dermatophagoides Pteronyssinus Allergen Extract

Study Overview
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Brief Summary
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The objective of this trial is to evaluate the clinical effectiveness of the administration of a depigmented and polymerized allergen extract Dermatophagoides pteronyssinus in children with allergic asthma due to this mite

Detailed Description
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Immunotherapy is a specific treatment for allergic diseases. Unlike conventional pharmacological treatment, immunotherapy is the only treatment that could modify the natural course of allergic disease. This is a prospective double-blind placebo controlled study with three arms of treatment: placebo and two active (one of the active arms will receive subcutaneous immunotherapy and the other one will receive sublingual immunotherapy).

Official Title
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Depigmented and Polymerised Allergenic Extract of Dermatophagoides Pteronyssinus as Antiasthmatic Treatment for Children With Slight Allergic Asthma to Mites

Conditions
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Allergic Asthma

Intervention / Treatment
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* Biological: DEPIGOID Dermatophagoides pteronyssinus
* Biological: Polymerized TOL of Dermatophagoides pteronyssinus
* Biological: Placebo Comparator


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Written informed consent signed by the patient and guardian. Positive clinical history of allergy to dust mites. FEV1 greater than or equal to 80% of the expected value and improvement in FEV1 greater than 12% after bronchodilation. Age-between 5 and 14 years. Sensitization to dust mites, diagnosed by positive skin tests to Dermatophagoides pteronyssinus: wheal size > 3 mm diameter and / or RAST (> 0.7 kU / L). Exclusion Criteria: Patients out of the age range. Use of immunotherapy during the last four years. Any contraindication for the use of immunotherapy in accordance with European Allergy and Clinical Immunology Immunotherapy Subcommittee criteria: Treatment with ß-blockers Patients who have a condition in which adrenaline is contraindicated (hyperthyroidism, hypertension, heart disease, etc..). Coexistence of immunopathological diseases (e.g. of the liver, kidney, the nervous system, thyroid gland, rheumatic diseases) in which autoimmune mechanisms play a role Patients suffering from immune deficiencies Patients with serious psychiatric / psychological disturbances Patients aspirin intolerance

Ages Eligible for Study
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Minimum Age: 5 Years
Maximum Age: 14 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: A<br>Subcutaneous administration | Biological: DEPIGOID Dermatophagoides pteronyssinus<br>* Subcutaneous administration:0.5 ml/month during 1 year<br>|
| Experimental: B<br>Sublingual administration | Biological: Polymerized TOL of Dermatophagoides pteronyssinus<br>* Sublingual immunotherapy. Two drops daily during 1 year<br>|
| Placebo Comparator: C<br>Sublingual administration | Biological: Placebo Comparator<br>* Sublingual immunotherapy. Two drops daily during 1 year<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Symptom and medication scores |  | 1 year per patient | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Comparison between sublingual and subcutaneous administration route, quality of life, cost-effectiveness, dose response prick-test, inflammatory markers, exhaled nitric oxide, inflammatory markers in exhalate bronchial condensate, use of health resources |  | 1 year per patient | 
| QoL | The Paediatric Asthma Quality of Life Questionnaire (PAQLQ) was developed to measure the functional problems (physical, emotional and social) that are most troublesome to children with asthmaQuestionnaire E. Juniper | 1 year | 
| Cost-effectiveness |  | 1 year | 
| Dose response prick-test |  | 1 year | 
| Inflammatory markers |  | 1 year | 
| Use of health resources |  | 1 year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Immunotherapy, Allergy, Allergoid, Depigmented, Polymerized, Allergen-extract, mites, Asthma