Efficacy and Safety Trial of Subcutaneous Immunotherapy in Mite Induced Asthma

Phase 4CompletedNCT00492076

ALK-Abelló A/S45 enrolled

Overview

The purpose of this study is to determine whether a short course of subcutaneous immunotherapy is efficacious in mite induced asthma. The efficacy is based on reduction in control medication.

The control of mild-moderate persistent asthma include the need of concomitant medication, as inhaled corticosteroids. However, compliance in perennial asthma is low. The aim of this study is to assess the possibility to reduce the need of concomitant medication through a short-course of subcutaneous immunotherapy.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

DOUBLE

Enrollment

Conditions

Allergic Asthma

Interventions

Pangramin Plus D. pteronyssinus 100%BIOLOGICAL

1. Active. Pangramin Plus D. pteronyssinus 100% 2. Placebo. Pangramin Plus placebo

Eligibility

Sex: ALLMin age: 14 YearsMax age: 55 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Mild/moderate persistent asthma * Positive skin prick test or specific IgE to mites * Age: 14-55 years old Exclusion Criteria: * Immunotherapy contraindications * Allergy to other inhalant allergens * Previous immunotherapy (5 years)with mites

Locations (1)

Hospital Virgen del Camino, Allergology Service

Pamplona, Navarre, Spain

Outcomes

Primary Outcomes

Reduction in inhaled corticosteroids

Time frame: 4 months

Secondary Outcomes

Reduction in symptoms and rescue medication Tolerability

Time frame: 4 months

Data from ClinicalTrials.gov

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