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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00263640
First Posted: December 9, 2005
Last Update Posted: January 15, 2015
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 (Responsible Party):
Allergopharma GmbH & Co. KG
  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
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, 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 ]
    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 ]
    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

Information from the National Library of Medicine

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Ages Eligible for Study:   6 Years to 40 Years   (Child, Adult)
Sexes Eligible for Study:   All
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
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): 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 ( EudraCT Number )
First Submitted: December 8, 2005
First Posted: December 9, 2005
Last Update Posted: January 15, 2015
Last Verified: January 2015

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

Additional relevant MeSH terms:
Hypersensitivity
Asthma
Respiratory Hypersensitivity
Immune System Diseases
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Hypersensitivity, Immediate
Aluminum Hydroxide
Adjuvants, Immunologic
Immunologic Factors
Physiological Effects of Drugs
Antacids
Molecular Mechanisms of Pharmacological Action
Gastrointestinal Agents


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