NCT00622362

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

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

• Status: Terminated
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 3 (actual)
• Sponsor: Laboratorios Leti, S.L. · Industry
• Sex: All
• Age: 5 Years – 14 Years
• Healthy volunteers: Not accepted

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).

Conditions

• Allergic Asthma

Interventions

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

Timeline

• Start date: 2008-01-01
• Primary completion: 2009-02-01
• Completion: 2009-02-01
• First posted: 2008-02-25
• Last updated: 2019-03-08

Locations

1 site across 1 country: Spain