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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Allergopharma GmbH & Co. KG
ClinicalTrials.gov Identifier:
NCT00263640
First received: December 8, 2005
Last updated: January 14, 2015
Last verified: January 2015
  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: Acaroid
Drug: Placebo
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
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:


Further study details as provided by Allergopharma GmbH & Co. KG:

Primary Outcome Measures:
  • Inhalative dose of fluticasone propionate [ Time Frame: After 2 years ] [ Designated as safety issue: No ]
    The primary endpoint variate was the change of inhalative dose of fluticasone propionate needed to ensure asthma control according to GINA recommendation.


Secondary Outcome Measures:
  • Pre-bronchodilator morning peak flow [ Time Frame: After 2 years ] [ Designated as safety issue: No ]
    Post treatment, the changes from baseline in the mean pre-bronchodilator morning peak flow during the last two weeks of the diary phases were determined.


Enrollment: 130
Study Start Date: May 2005
Study Completion Date: August 2012
Primary Completion Date: April 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: Placebo
Placebo was given the same way as a subcutaneous (just under the skin) injection. Children received lifestyle counselling.
Drug: Placebo
Placebo was given the same way as a subcutaneous (just under the skin) injection. Patients were treated according the same dosing schedule of active group. Children received lifestyle counselling.
Other Name: Comparator
Experimental: Acaroid
The drug tested in this study (aluminium hydroxide-adsorbed house dust mite (D. pteronyssinus) allergoid preparation) was given as a subcutaneous injections of increasing doses.
Biological: Acaroid
The drug tested in this study (aluminium hydroxide-adsorbed house dust mite (D. pteronyssinus) allergoid preparation) was given as a subcutaneous injections of increasing doses.
Other Name: Specific Immunotherapy

Detailed Description:

The rationale for the present study was to demonstrate clinical efficacy and tolerability compared to placebo in a phase III clinical study of pivotal character with a representative number of patients suffering from fully reversible asthma +/- allergic rhinitis. This condition is present in paediatric and adult patients with a shorter history of GINA II and III asthma, who were investigated in this study.

  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
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 ClinicalTrials.gov identifier: NCT00263640

Locations
Germany
Allergopharma GmbH & Co. KG
Reinbek, Germany, 21465
Sponsors and Collaborators
Allergopharma GmbH & Co. KG
Investigators
Principal Investigator: Annemie Narkus, M.D. Allergopharma GmbH & Co. KG
  More Information

Additional Information:
Publications:
Responsible Party: Allergopharma GmbH & Co. KG
ClinicalTrials.gov Identifier: NCT00263640     History of Changes
Other Study ID Numbers: Al0104av, 2004-003892-35
Study First Received: December 8, 2005
Last Updated: January 14, 2015
Health Authority: Germany: Paul-Ehrlich-Institut

Keywords provided by Allergopharma GmbH & Co. KG:
House dust mite
Bronchial Asthma
Allergy
House Dust Mite Allergy

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

ClinicalTrials.gov processed this record on July 01, 2015