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

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

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00263640

Enrollment

130

Registered

2005-12-09

Start date

2005-05-31

Completion date

2012-08-31

Last updated

2015-01-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Respiratory Hypersensitivity

Keywords

House dust mite, Bronchial Asthma, Allergy, House Dust Mite Allergy

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.

Interventions

BIOLOGICALAcaroid

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.

DRUGPlacebo

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.

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

6 Years to 40 Years

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

Design outcomes

Primary

Measure	Time frame	Description
Inhalative dose of fluticasone propionate	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

Measure	Time frame	Description
Pre-bronchodilator morning peak flow	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.

Countries

Germany

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026