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

Last updated: January 23, 2025
Sponsor: Stallergenes Greer
Overall Status: Terminated

Phase

3

Condition

Common Cold

Allergy

Nasal Obstruction

Treatment

300 IR house dust mites allergen extract tablet

Placebo tablet

Clinical Study ID

NCT01199133
VO64.08
2009-011999-30
  • Ages 5-17
  • All Genders

Study Summary

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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Male or female outpatients, aged 5-17 years inclusive

  • History of house dust mite-related allergic rhinitis for at least 1 year requiringregular intake of symptomatic treatment(s)

  • Sensitised to D. pteronyssinus and/or D. farinae (positive skin prick test withwheal diameter greater than 3 mm and specific IgE level ≥ 0.7 kU/L)

Exclusion

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 endemicto the region

Study Design

Total Participants: 471
Treatment Group(s): 2
Primary Treatment: 300 IR house dust mites allergen extract tablet
Phase: 3
Study Start date:
October 01, 2009
Estimated Completion Date:
September 30, 2011

Study 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.