Safety and Efficacy Study of Sublingual Immunotherapy (SLIT) to Treat House Dust Mite Allergic Rhinitis in Adolescents and Children
|Allergic Rhinitis Due to Dust Mite||Drug: Dpte and Dfar Allergen Extracts Drug: placebo||Phase 3|
|Study Design:||Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Participant, Investigator)
Primary Purpose: Treatment
|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|
- Efficacy Assessment [ Time Frame: 12 months ]Evaluation of the Average Adjusted Symptom Score (AASS) during the treatment period
- Efficacy Assessment at the end of the treatment phase and at the end of the Treatment free follow up phase [ Time Frame: 60 months ]AASS, ARTSS (average rhinitis total symptom score), ARMS (average rescue medication score),ARSS (individual average rhinoconjunctivitis symptom score), RQLQ (Rhinoconjunctivitis Quality of Life Questionnaire Score), Safety
|Study Start Date:||October 2009|
|Study Completion Date:||September 2011|
|Primary Completion Date:||January 2011 (Final data collection date for primary outcome measure)|
|Active Comparator: Dpte and Dfar Allergen Extract||
Drug: Dpte and Dfar Allergen Extracts
300 IR, once a day, for one year.
|Placebo Comparator: Placebo tablets||
once a day, for one year.
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01199133
|Study Chair:||Ulrich Wahn, MD||Charite- Campus Virchow klinikum|