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

January 14, 2015 updated by: Allergopharma GmbH & Co. KG

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

130

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
      • Reinbek, Germany, 21465
        • Allergopharma GmbH & Co. KG

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

2 years to 36 years (Child, Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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 Names:
  • 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 Names:
  • Specific Immunotherapy

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
After 2 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
After 2 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Allergopharma GmbH & Co. KG

Investigators

  • Principal Investigator: Annemie Narkus, M.D., Allergopharma GmbH & Co. KG

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2005

Primary Completion (Actual)

April 1, 2009

Study Completion (Actual)

August 1, 2012

Study Registration Dates

First Submitted

December 8, 2005

First Submitted That Met QC Criteria

December 8, 2005

First Posted (Estimate)

December 9, 2005

Study Record Updates

Last Update Posted (Estimate)

January 15, 2015

Last Update Submitted That Met QC Criteria

January 14, 2015

Last Verified

January 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Al0104av
  • 2004-003892-35 (EudraCT Number)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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