Safety and Efficacy Study of Sublingual Immunotherapy (SLIT) to Treat House Dust Mite Allergic Rhinitis in Adolescents and Children

Study Results

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Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE3

Total Enrollment

471 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-10-31

Study Completion Date

2011-09-30

Brief Summary

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The purpose of this study is to assess the efficacy of one dose of sublingual immunotherapy (SLIT) administered to children and adolescents as allergen-based tablets once daily over a period of 24 months over 3 years compared to placebo, for reduction of allergic rhinitis symptoms and rescue medication use.

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Detailed Description

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After the screening period, the patients will be administered 300 IR house dust mite allergen based tablets or placebo, once a day, for a period of 36 months with two windows of 8 months and 6 months without treatment. The carry over effect will be evaluated after a treatment free follow up period of 24 months.

An independent Data Monitoring Committee will be constituted to evaluate the efficacy and safety data at the end of Year 1 and Year 3, and the post-treatment long-term efficacy data at the end of year 4.

Conditions

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Allergic Rhinitis Due to Dust Mite

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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300 IR

300 IR house dust mites allergen extract tablet

Group Type ACTIVE_COMPARATOR

300 IR house dust mites allergen extract tablet

Intervention Type DRUG

One sublingual tablet daily for one year.

Placebo

Placebo tablet

Group Type PLACEBO_COMPARATOR

Placebo tablet

Intervention Type DRUG

One sublingual tablet daily for one year.

Interventions

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300 IR house dust mites allergen extract tablet

One sublingual tablet daily for one year.

Intervention Type DRUG

Placebo tablet

One sublingual tablet daily for one year.

Intervention Type DRUG

Other Intervention Names

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House dust mites (Der p and Der f) allergen extract tablet Sublingual placebo tablet

Eligibility Criteria

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Inclusion Criteria

* Male or female outpatients, aged 5-17 years inclusive
* History of house dust mite-related allergic rhinitis for at least 1 year requiring regular intake of symptomatic treatment(s)
* Sensitised to D. pteronyssinus and/or D. farinae (positive skin prick test with wheal diameter greater than 3 mm and specific IgE level ≥ 0.7 kU/L)

Exclusion Criteria

• Co-sensitization associated with clinically relevant allergic rhinitis, sinusitis, conjunctivitis or asthma likely to significantly change the symptoms of the patient throughout the study (that means patient symptomatic to another allergen than house dust mites to which the patient will be exposed during the study, i.e. will notably be excluded

* patients sensitised to cat or dog allergens and regularly exposed to these allergens
* patients sensitised to aspergillus, cladosporium, alternaria
* patients sensitised to parietaria , ragweed, or mugwort, if this allergen is endemic to the region

Minimum Eligible Age

5 Years

Maximum Eligible Age

17 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No