Allergic Asthma
Conditions
Keywords
Immunotherapy, Allergy, Allergoid, Depigmented, Polymerized, Allergen-extract, mites, Asthma
Brief summary
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
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).
Interventions
BIOLOGICALDEPIGOID Dermatophagoides pteronyssinus
Subcutaneous administration:0.5 ml/month during 1 year
BIOLOGICALPolymerized TOL of Dermatophagoides pteronyssinus
Sublingual immunotherapy. Two drops daily during 1 year
BIOLOGICALPlacebo Comparator
Sublingual immunotherapy. Two drops daily during 1 year
Sponsors
Laboratorios Leti, S.L.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
5 Years to 14 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Symptom and medication scores | 1 year per patient |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| QoL | 1 year | 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 |
| Cost-effectiveness | 1 year | — |
| 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 | — |
| Inflammatory markers | 1 year | — |
| Use of health resources | 1 year | — |
| Dose response prick-test | 1 year | — |
Countries
Spain
Outcome results
None listed