Status:
TERMINATED
Safety and Efficacy Study of Sublingual Immunotherapy (SLIT) to Treat House Dust Mite Allergic Rhinitis in Adolescents and Children
Lead Sponsor:
Stallergenes Greer
Conditions:
Allergic Rhinitis Due to Dust Mite
Eligibility:
All Genders
5-17 years
Phase:
PHASE3
Brief 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 mon...
Detailed 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 ...
Eligibility Criteria
Inclusion
- 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
- • 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
Key Trial Info
Start Date :
October 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2011
Estimated Enrollment :
471 Patients enrolled
Trial Details
Trial ID
NCT01199133
Start Date
October 1 2009
End Date
September 1 2011
Last Update
February 11 2025
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