Status:
TERMINATED
Subcutaneous-Sublingual Immunotherapy With Depigmented and Polymerized Dermatophagoides Pteronyssinus Allergen Extract
Lead Sponsor:
Laboratorios Leti, S.L.
Conditions:
Allergic Asthma
Eligibility:
All Genders
5-14 years
Phase:
PHASE2
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 a...
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...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
January 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 1 2009
Estimated Enrollment :
3 Patients enrolled
Trial Details
Trial ID
NCT00622362
Start Date
January 1 2008
End Date
February 1 2009
Last Update
March 8 2019
Active Locations (1)
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1
Hospital Universitario La Fé
Valencia, Spain, 46009