Clinical trial NCT00622362: Subcutaneous-Sublingual Immunotherapy With Depigmented and Polymerized Dermatophagoides Pteronyssinus Allergen Extract
Official title: Depigmented and Polymerised Allergenic Extract of Dermatophagoides Pteronyssinus as Antiasthmatic Treatment for Children With Slight Allergic Asthma to Mites
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Allergic Asthma
Keywords: Immunotherapy
Allergy
Allergoid
Depigmented
Polymerized
Allergen-extract
mites
Asthma
Lead sponsor: Laboratorios Leti, S.L.
Sponsor class: INDUSTRY
First posted: 2008-02-25
Enrollment: 3
Sex: ALL
Minimum age (years): 5
Maximum age (years): 14
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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).

Eligibility criteria: 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

Primary outcomes:
measure: Symptom and medication scores
timeFrame: 1 year per patient
Secondary outcomes:
measure: 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
timeFrame: 1 year per patient
measure: QoL
timeFrame: 1 year
measure: Cost-effectiveness
timeFrame: 1 year
measure: Dose response prick-test
timeFrame: 1 year
measure: Inflammatory markers
timeFrame: 1 year
measure: Use of health resources
timeFrame: 1 year
Other outcomes:
Locations:
city: Valencia
country: Spain
facility: Hospital Universitario La Fé
Study officials:
name: Antonio Nieto, MD PhD
role: PRINCIPAL_INVESTIGATOR
References: