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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE2

Total Enrollment

3 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-01-31

Study Completion Date

2009-02-28

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

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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).

Conditions

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Allergic Asthma

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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A

Subcutaneous administration

Group Type ACTIVE_COMPARATOR

DEPIGOID Dermatophagoides pteronyssinus

Intervention Type BIOLOGICAL

Subcutaneous administration:0.5 ml/month during 1 year

B

Sublingual administration

Group Type EXPERIMENTAL

Polymerized TOL of Dermatophagoides pteronyssinus

Intervention Type BIOLOGICAL

Sublingual immunotherapy. Two drops daily during 1 year

C

Sublingual administration

Group Type PLACEBO_COMPARATOR

Placebo Comparator

Intervention Type BIOLOGICAL

Sublingual immunotherapy. Two drops daily during 1 year

Interventions

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DEPIGOID Dermatophagoides pteronyssinus

Subcutaneous administration:0.5 ml/month during 1 year

Intervention Type BIOLOGICAL

Polymerized TOL of Dermatophagoides pteronyssinus

Sublingual immunotherapy. Two drops daily during 1 year

Intervention Type BIOLOGICAL

Placebo Comparator

Sublingual immunotherapy. Two drops daily during 1 year

Intervention Type BIOLOGICAL

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

Minimum Eligible Age

5 Years

Maximum Eligible Age

14 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No