Allergic Rhinitis Due to Dust Mite Clinical Trial
Official title:
A Randomised,Double-blind,Placebo-controlled,Multi National,Phase III Trial to Assess the Efficacy and Safety of 300 IR Sublingual Immunotherapy Administered as Allergen-based Tablets Once Daily to Adolescents and Children Above the Age of 5 Years, Suffering From House Dust Mite Allergic Rhinitis
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.
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.
;
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Completed |
NCT01568190 -
An Open Trial to Assess the Tolerability of AVANZ Mite Mix Immunotherapy
|
Phase 2/Phase 3 |