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

Laboratorios Leti, S.L.1 site in 1 country3 target enrollmentJanuary 2008

ConditionsAllergic Asthma

Overview

Phase: Phase 2
Intervention: Not specified
Conditions: Allergic Asthma
Sponsor: Laboratorios Leti, S.L.
Enrollment: 3
Locations: 1
Primary Endpoint: Symptom and medication scores
Status: Terminated
Last Updated: 7 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

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).

Registry

clinicaltrials.gov

Start Date

January 2008

End Date

February 2009

Last Updated

7 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Laboratorios Leti, S.L.

Responsible Party

Sponsor

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

Outcomes

Primary Outcomes

Symptom and medication scores

Time Frame: 1 year per patient

Secondary Outcomes

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(1 year)
Cost-effectiveness(1 year)
Dose response prick-test(1 year)
Inflammatory markers(1 year)
Use of health resources(1 year)