Safety and Efficacy Study of Sublingual Immunotherapy (SLIT) to Treat House Dust Mite Allergic Rhinitis in Adolescents and Children
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|ClinicalTrials.gov Identifier: NCT01199133|
Recruitment Status : Terminated (Following the DSMB recommendation. Study population being insufficiently symptomatic to enable differentiation between treatment and placebo. No safety concerns)
First Posted : September 10, 2010
Last Update Posted : December 21, 2011
|Condition or disease||Intervention/treatment||Phase|
|Allergic Rhinitis Due to Dust Mite||Drug: Dpte and Dfar Allergen Extracts Drug: placebo||Phase 3|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||471 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Participant, Investigator)|
|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|
|Study Start Date :||October 2009|
|Actual Primary Completion Date :||January 2011|
|Actual Study Completion Date :||September 2011|
|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.
- 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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01199133
|Study Chair:||Ulrich Wahn, MD||Charite- Campus Virchow klinikum|