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

NCT ID: NCT00263640

Last Updated: 2015-01-15

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

130 participants

Study Classification

INTERVENTIONAL

Study Start Date

2005-05-31

Study Completion Date

2012-08-31

Brief Summary

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

Detailed Description

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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.

Conditions

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Respiratory Hypersensitivity

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Placebo

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

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

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.

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.

Group Type EXPERIMENTAL

Acaroid

Intervention Type BIOLOGICAL

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.

Interventions

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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.

Intervention Type BIOLOGICAL

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.

Intervention Type DRUG

Other Intervention Names

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Specific Immunotherapy Comparator

Eligibility Criteria

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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
Minimum Eligible Age

6 Years

Maximum Eligible Age

40 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Allergopharma GmbH & Co. KG

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Annemie Narkus, M.D.

Role: PRINCIPAL_INVESTIGATOR

Allergopharma GmbH & Co. KG

Locations

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Allergopharma GmbH & Co. KG

Reinbek, , Germany

Site Status

Countries

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Germany

References

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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.

Reference Type RESULT
PMID: 20624650 (View on PubMed)

Related Links

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http://www.allergopharma.de

Leader in specific allergy research and therapy

Other Identifiers

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2004-003892-35

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

Al0104av

Identifier Type: -

Identifier Source: org_study_id

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