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

Phase 2

Terminated

• Conditions: Allergic Asthma
• Interventions: Biological: Placebo Comparator; Biological: Polymerized TOL of Dermatophagoides pteronyssinus; Biological: DEPIGOID Dermatophagoides pteronyssinus

• Registration Number: NCT00622362
• Lead Sponsor: Laboratorios Leti, S.L.

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).

Study Timeline

• Study Start: 2008-01
• Study First Submitted: 2008-01-10
• Study First Submitted QC: 2008-02-13
• Study First Posted: 2008-02-25
• Primary Completion: 2009-02
• Study Completion: 2009-02
• Status Verified: 2019-03
• Last Update Submitted: 2019-03-06
• Last Update Posted: 2019-03-08

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 3

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
C	Placebo Comparator	Sublingual administration
B	Polymerized TOL of Dermatophagoides pteronyssinus	Sublingual administration
A	DEPIGOID Dermatophagoides pteronyssinus	Subcutaneous administration

Primary Outcome Measures

Name	Time	Method
Symptom and medication scores	1 year per patient

Secondary Outcome Measures

Name	Time	Method
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	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
Dose response prick-test	1 year
Inflammatory markers	1 year
Use of health resources	1 year

Trial Locations

Locations (1)

Hospital Universitario La Fé; 🇪🇸 Valencia, Spain