At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 533 enrolled
Drug / intervention
HDM SLIT-tablet +1 morebiological
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 Phase III Trial Evaluating the Efficacy and Safety of the House Dust Mite (HDM) Sublingual Immunotherapy (SLIT)-Tablet in Children and Adolescents (5-17 Years) With HDM Allergic Asthma
In Brief
A Phase 3 clinical trial evaluating HDM SLIT-tablet and Placebo for Allergic Asthma Due to Dermatophagoides Farinae and 2 related conditions. Completed, enrolled 533 participants across 64 sites in 9 countries.
Detailed Summary
The trial aims to demonstrate efficacy of the House Dust Mite SLIT-tablet versus placebo as add-on treatment in children and adolescents (5-17 years) with House Dust Mite allergic asthma based on clinically relevant asthma worsening.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsAllergic Asthma Due to Dermatophagoides Farinae, Allergic Asthma Due to Dermatophagoides Pteronyssinus, Allergic Rhinitis Due to House Dust Mite
CountriesBulgaria, France, Germany, Hungary, Poland, Russia, Spain, United Kingdom, United States
Collaborators--
Timeline
Phase 3CompletedFinished
201820192020202120222023202420252026
Enrollment StartFeb 2018
First PostedAug 2018
Primary CompletionMay 2022
Study CompletionMay 2022
TodayJul 2026
First PostedAug 31, 2018
Enrollment StartFeb 22, 2018
Primary CompletionMay 18, 2022
Study CompletionMay 31, 2022
TodayJul 2, 2026
Enrollment to primary: 4.2 yearsPosted 7.8 years ago
Interventions
HDM SLIT-tabletbiological
Sublingual allergy immunotherapy tablet, for daily administration (1 tablet per day)
Placeboother
Placebo sublingual tablet, for daily administration (1 tablet per day)