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Efficacy and Safety Trial of Subcutaneous Immunotherapy in Mite Induced Asthma

This study has been completed.
Sponsor:
Information provided by:
ALK-Abelló A/S
ClinicalTrials.gov Identifier:
NCT00492076
First received: June 26, 2007
Last updated: October 15, 2008
Last verified: October 2008
History of Changes
  Purpose

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.


Condition Intervention Phase
Allergic Asthma
 Biological: Pangramin Plus D. pteronyssinus 100%
 Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Prevention
Official Title: A Randomised, Double-Blind Placebo-Controlled Study Assessing the Short-Term Effect of a Dermatophagoides Pteronyssinus Extract, Quantified in Mass Units, in Subjects With Perennial Mite Induced Asthma

Resource links provided by NLM:

MedlinePlus related topics: Asthma
U.S. FDA Resources

Further study details as provided by ALK-Abelló A/S:

Primary Outcome Measures:
  • Reduction in inhaled corticosteroids [ Time Frame: 4 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Reduction in symptoms and rescue medication Tolerability [ Time Frame: 4 months ] [ Designated as safety issue: Yes ]

Enrollment: 45
Study Start Date: October 2006
Study Completion Date: May 2008
Primary Completion Date: May 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: 1
Pangramin Plus Dermatophagoides pteronyssinus 100%
 Biological: Pangramin Plus D. pteronyssinus 100%
  1. Active. Pangramin Plus D. pteronyssinus 100%
  2. Placebo. Pangramin Plus placebo
Placebo Comparator: 2
Pangramin Plus placebo
 Biological: Pangramin Plus D. pteronyssinus 100%
  1. Active. Pangramin Plus D. pteronyssinus 100%
  2. Placebo. Pangramin Plus placebo

Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   14 Years to 55 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00492076

Locations
Spain
Hospital Virgen del Camino, Allergology Service
Pamplona, Navarra, Spain, 31002
Sponsors and Collaborators
ALK-Abelló A/S
Investigators
Principal Investigator: Ana I Tabar, MD PhD Hospital Virgen del Camino
  More Information

No publications provided

Responsible Party: Fernando de la Torre/medical marketing manager, ALK-ABELLO, S.A.
ClinicalTrials.gov Identifier: NCT00492076     History of Changes
Other Study ID Numbers: E04/05/PP-M
Study First Received: June 26, 2007
Last Updated: October 15, 2008
Health Authority: Spain: Spanish Agency of Medicines

Keywords provided by ALK-Abelló A/S:
Specific immunotherapy
Mite
Asthma

Additional relevant MeSH terms:
Asthma
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
 Respiratory Hypersensitivity
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases

ClinicalTrials.gov processed this record on June 18, 2013