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

Study Overview
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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.

Official Title
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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

Conditions
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Respiratory Hypersensitivity

Intervention / Treatment
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* Biological: Acaroid
* Drug: Placebo


Participation Criteria
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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

Ages Eligible for Study
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Minimum Age: 6 Years
Maximum Age: 40 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Placebo<br>Placebo was given the same way as a subcutaneous (just under the skin) injection. Children received lifestyle counselling. | Drug: Placebo<br>* 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.<br>* Other names: Comparator;|
| Experimental: Acaroid<br>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<br>* 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.<br>* Other names: Specific Immunotherapy;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | After 2 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | After 2 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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House dust mite, Bronchial Asthma, Allergy, House Dust Mite Allergy