At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 509 enrolled
Drug / intervention
300 IR house dust mites allergen extract tablet +2 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Randomized, DBPC, Multi-national Phase II/III Study of the Safety and Efficacy of Two Doses of Sublingual Immunotherapy (SLIT) Administered as Allergen-based Tablets Once Daily to Adult Patients Suffering From HDM Allergic Rhinitis
In Brief
A Phase 3 clinical trial evaluating 300 IR house dust mites allergen extract tablet, 500 IR house dust mites allergen extract tablet, and 1 other intervention for Allergic Rhinitis. Completed, enrolled 509 participants.
Detailed Summary
The purpose of this study is to assess the efficacy of two doses of sublingual immunotherapy (SLIT) administered as allergen-based tablets once daily over a period of 12 months compared to placebo, for reduction of allergic rhinitis symptoms and rescue medication usage
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsAllergic Rhinitis
Countries--
Collaborators--
Timeline
Phase 3CompletedFinished
20082009201020112012201320142015201620172018201920202021202220232024202520262027
Enrollment StartOct 2007
First PostedMay 2008
Primary CompletionFeb 2009
Study CompletionFeb 2010
TodayJul 2026
First PostedMay 8, 2008
Enrollment StartOct 1, 2007
Primary CompletionFeb 1, 2009
Study CompletionFeb 1, 2010
TodayJul 2, 2026
Enrollment to primary: 1.3 yearsPosted 18.2 years ago
Interventions
300 IR house dust mites allergen extract tabletdrug
One sublingual tablet daily for one year
500 IR house dust mites allergen extract tabletdrug
One sublingual tablet daily for one year
Placebo tabletdrug
One sublingual tablet daily for one year