Try our beta test site
IMPORTANT: Listing of a study on this site does not reflect endorsement by the National Institutes of Health. Talk with a trusted healthcare professional before volunteering for a study. Read more...

Efficacy and Safety Trial of Subcutaneous Immunotherapy in Mite Induced Asthma

This study has been completed.
Information provided by:
ALK-Abelló A/S Identifier:
First received: June 26, 2007
Last updated: October 15, 2008
Last verified: October 2008
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 Blind (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.

Ages Eligible for Study:   14 Years to 55 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT00492076

Hospital Virgen del Camino, Allergology Service
Pamplona, Navarra, Spain, 31002
Sponsors and Collaborators
ALK-Abelló A/S
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. Identifier: NCT00492076     History of Changes
Other Study ID Numbers: E04/05/PP-M
Study First Received: June 26, 2007
Last Updated: October 15, 2008

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

Additional relevant MeSH terms:
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Immune System Diseases processed this record on May 24, 2017