Safety and Efficacy of House Dust Mite Allergoid in the Treatment of Bronchial Asthma

This study is ongoing, but not recruiting participants.

First Received on December 8, 2005. Last Updated on October 14, 2011 History of Changes

Sponsor:	Allergopharma Joachim Ganzer KG
Information provided by (Responsible Party):	Allergopharma Joachim Ganzer KG
ClinicalTrials.gov Identifier:	NCT00263640

Purpose

The trial is performed to assess efficacy and safety of the Allergopharma house dust mite allergoid in bronchial asthma.

Condition	Intervention	Phase
Respiratory Hypersensitivity	Biological: House dust mite, Acaroid	Phase III

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double-Blind Primary Purpose: Treatment
Official Title:	A Multicentre Randomised Placebo-controlled Double-blind Clinical Trial for Evaluation of Safety and Efficacy of Specific Immunotherapy With an Alum.-Adsorbed Allergoid Preparation of House Dust Mite (D. Pteronyssinus) in Patients With Allergic Bronchial Asthma, Rhinitis, Rhinoconjunctivitis

Resource links provided by NLM:

MedlinePlus related topics: Allergy Asthma

U.S. FDA Resources

Further study details as provided by Allergopharma Joachim Ganzer KG:

Study Start Date:	May 2005
Estimated Study Completion Date:	April 2012
Primary Completion Date:	April 2009 (Final data collection date for primary outcome measure)

Eligibility

Ages Eligible for Study:	6 Years to 40 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Bronchial asthma
Requirements for inhaled corticosteroid
Positive skin prick test to house dust mite
Positive radioallergosorbent test (RAST) to house dust mite
Positive provocation test result to house dust mite

Exclusion Criteria:

Serious chronic diseases
Other perennial allergies

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00263640

Locations

Germany
Allergopharma Joachim Ganzer KG
Reinbek, Germany, 21465

Sponsors and Collaborators

Allergopharma Joachim Ganzer KG

Investigators

Principal Investigator:

Annemie Narkus, M.D.

Allergopharma Joachim Ganzer KG

More Information

Additional Information:

Leader in specific allergy research and therapy This link exits the ClinicalTrials.gov site

No publications provided by Allergopharma Joachim Ganzer KG

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Zielen S, Kardos P, Madonini E. Steroid-sparing effects with allergen-specific immunotherapy in children with asthma: a randomized controlled trial. J Allergy Clin Immunol. 2010 Nov;126(5):942-9. Epub 2010 Jul 10.

Responsible Party:	Allergopharma Joachim Ganzer KG
ClinicalTrials.gov Identifier:	NCT00263640 History of Changes
Other Study ID Numbers:	Al0104av
Study First Received:	December 8, 2005
Last Updated:	October 14, 2011
Health Authority:	Germany: Paul-Ehrlich-Institut

Keywords provided by Allergopharma Joachim Ganzer KG:

House dust mite
Bronchial Asthma
Allergy
House Dust Mite Allergy

Additional relevant MeSH terms:

Asthma
Hypersensitivity
Respiratory Hypersensitivity
Bronchial Diseases
Respiratory Tract Diseases

Lung Diseases, Obstructive
Lung Diseases
Hypersensitivity, Immediate
Immune System Diseases

ClinicalTrials.gov processed this record on February 09, 2012