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

Allergic Asthma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00622362
• Other study ID #: 2006-000571-15
• Secondary ID: 101-PG-COM-143
• Status: Terminated
• Phase: Phase 2
• Start date: January 2008
• Est. completion date: February 2009

Study information

• Verified date: March 2019
• Source: Laboratorios Leti, S.L.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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).

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 3
• Est. completion date: February 2009
• Est. primary completion date: February 2009
• Accepts healthy volunteers: No
• Gender: All
• Age group: 5 Years to 14 Years

Eligibility

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

Related Conditions & MeSH terms

• Allergic Asthma
• Asthma

Intervention

Biological:
• DEPIGOID Dermatophagoides pteronyssinus
Subcutaneous administration:0.5 ml/month during 1 year
• Polymerized TOL of Dermatophagoides pteronyssinus
Sublingual immunotherapy. Two drops daily during 1 year
• Placebo Comparator
Sublingual immunotherapy. Two drops daily during 1 year

Locations

Country	Name	City	State
Spain	Hospital Universitario La Fé	Valencia

Sponsors (1)

Lead Sponsor	Collaborator
Laboratorios Leti, S.L.

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Symptom and medication scores		1 year per patient
Secondary	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
Secondary	QoL	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	1 year
Secondary	Cost-effectiveness		1 year
Secondary	Dose response prick-test		1 year
Secondary	Inflammatory markers		1 year
Secondary	Use of health resources		1 year