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Efficacy and Safety Trial of Subcutaneous Immunotherapy in Mite Induced Asthma

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00492076
First Posted: June 27, 2007
Last Update Posted: October 16, 2008
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
ALK-Abelló A/S
  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
Intervention Model: Parallel Assignment
Masking: Double (Participant, 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:


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

Primary Outcome Measures:
  • Reduction in inhaled corticosteroids [ Time Frame: 4 months ]

Secondary Outcome Measures:
  • Reduction in symptoms and rescue medication Tolerability [ Time Frame: 4 months ]

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

Information from the National Library of Medicine

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Ages Eligible for Study:   14 Years to 55 Years   (Child, Adult)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

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
First Submitted: June 26, 2007
First Posted: June 27, 2007
Last Update Posted: October 16, 2008
Last Verified: October 2008

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