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Efficacy and Safety Trial of Subcutaneous Immunotherapy in Mite Induced Asthma

NCT ID: NCT00492076

Last Updated: 2008-10-16

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

45 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-10-31

Study Completion Date

2008-05-31

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Allergic Asthma

Keywords

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Specific immunotherapy Mite Asthma

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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1

Pangramin Plus Dermatophagoides pteronyssinus 100%

Group Type ACTIVE_COMPARATOR

Pangramin Plus D. pteronyssinus 100%

Intervention Type BIOLOGICAL

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

2

Pangramin Plus placebo

Group Type PLACEBO_COMPARATOR

Pangramin Plus D. pteronyssinus 100%

Intervention Type BIOLOGICAL

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

Interventions

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Pangramin Plus D. pteronyssinus 100%

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

Intervention Type BIOLOGICAL

Eligibility Criteria

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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
Minimum Eligible Age

14 Years

Maximum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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ALK-Abelló A/S

INDUSTRY

Sponsor Role lead

Responsible Party

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ALK-ABELLO, S.A.

Principal Investigators

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Ana I Tabar, MD PhD

Role: PRINCIPAL_INVESTIGATOR

Hospital Virgen del Camino

Locations

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Hospital Virgen del Camino, Allergology Service

Pamplona, Navarre, Spain

Site Status

Countries

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Spain

Other Identifiers

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E04/05/PP-M

Identifier Type: -

Identifier Source: org_study_id