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

Primary Purpose

Respiratory Hypersensitivity

Status
Completed
Phase
Phase 3
Locations
Germany
Study Type
Interventional
Intervention
Acaroid
Placebo
Sponsored by
Allergopharma GmbH & Co. KG
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Respiratory Hypersensitivity focused on measuring House dust mite, Bronchial Asthma, Allergy, House Dust Mite Allergy

Eligibility Criteria

6 Years - 40 Years (Child, Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Allergopharma GmbH & Co. KG

Arms of the Study

Arm 1

Arm 2

Arm Type

Placebo Comparator

Experimental

Arm Label

Placebo

Acaroid

Arm Description

Placebo was given the same way as a subcutaneous (just under the skin) injection. Children received lifestyle counselling.

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.

Outcomes

Primary Outcome Measures

Inhalative dose of fluticasone propionate
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
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.

Full Information

First Posted
December 8, 2005
Last Updated
January 14, 2015
Sponsor
Allergopharma GmbH & Co. KG
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1. Study Identification

Unique Protocol Identification Number
NCT00263640
Brief Title
Safety and Efficacy of House Dust Mite Allergoid in the Treatment of Bronchial Asthma
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
Study Type
Interventional

2. Study Status

Record Verification Date
January 2015
Overall Recruitment Status
Completed
Study Start Date
May 2005 (undefined)
Primary Completion Date
April 2009 (Actual)
Study Completion Date
August 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Allergopharma GmbH & Co. KG

4. Oversight

Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Respiratory Hypersensitivity
Keywords
House dust mite, Bronchial Asthma, Allergy, House Dust Mite Allergy

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
130 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Placebo was given the same way as a subcutaneous (just under the skin) injection. Children received lifestyle counselling.
Arm Title
Acaroid
Arm Type
Experimental
Arm Description
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.
Intervention Type
Biological
Intervention Name(s)
Acaroid
Other Intervention Name(s)
Specific Immunotherapy
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
Placebo
Other Intervention Name(s)
Comparator
Intervention Description
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.
Primary Outcome Measure Information:
Title
Inhalative dose of fluticasone propionate
Description
The primary endpoint variate was the change of inhalative dose of fluticasone propionate needed to ensure asthma control according to GINA recommendation.
Time Frame
After 2 years
Secondary Outcome Measure Information:
Title
Pre-bronchodilator morning peak flow
Description
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.
Time Frame
After 2 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
6 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Annemie Narkus, M.D.
Organizational Affiliation
Allergopharma GmbH & Co. KG
Official's Role
Principal Investigator
Facility Information:
Facility Name
Allergopharma GmbH & Co. KG
City
Reinbek
ZIP/Postal Code
21465
Country
Germany

12. IPD Sharing Statement

Citations:
PubMed Identifier
20624650
Citation
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. doi: 10.1016/j.jaci.2010.06.002. Epub 2010 Jul 10.
Results Reference
result
Links:
URL
http://www.allergopharma.de
Description
Leader in specific allergy research and therapy

Learn more about this trial

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

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