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

Leti Pharma

Status and phase: Terminated; Phase 2

Conditions: Allergic Asthma

Treatments: Biological: DEPIGOID Dermatophagoides pteronyssinus; Biological: Placebo Comparator; Biological: Polymerized TOL of Dermatophagoides pteronyssinus

Study type: Interventional

Funder types: Industry

Identifiers

NCT00622362

101-PG-COM-143

2006-000571-15

Details and patient eligibility

About

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

Full 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).

Enrollment: 3 patients

Sex: All

Ages: 5 to 14 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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3 participants in 3 patient groups, including a placebo group

A

Active Comparator group

Description:

Subcutaneous administration

Treatment:

Biological: DEPIGOID Dermatophagoides pteronyssinus

B

Experimental group

Description:

Sublingual administration

Treatment:

Biological: Polymerized TOL of Dermatophagoides pteronyssinus

C

Placebo Comparator group

Description:

Sublingual administration

Treatment:

Biological: Placebo Comparator