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

Stallergenes Greer

Status and phase: Terminated; Phase 3

Conditions: Allergic Rhinitis Due to Dust Mite

Treatments: Drug: 300 IR house dust mites allergen extract tablet; Drug: Placebo tablet

Study type: Interventional

Funder types: Industry

Identifiers

NCT01199133

VO64.08

2009-011999-30 (EudraCT Number)

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 471 patients

Sex: All

Ages: 5 to 17 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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471 participants in 2 patient groups, including a placebo group

300 IR

Active Comparator group

Description:

300 IR house dust mites allergen extract tablet

Treatment:

Drug: 300 IR house dust mites allergen extract tablet

Placebo

Placebo Comparator group

Description:

Placebo tablet

Treatment:

Drug: Placebo tablet