At a glance
ClinicalIndex Comparison RecordPhase 2Completed· 715 enrolled
Drug / intervention
HDM-SPIRE +1 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 Double-Blind, Randomised, Placebo-Controlled, Multi-Centre Field Study to Assess the Efficacy and Safety of HDM-SPIRE in Subjects With a History of House Dust Mite-Induced Rhinoconjunctivitis
In Brief
A Phase 2 clinical trial evaluating HDM-SPIRE and Placebo for Rhinoconjunctivitis. Completed, enrolled 715 participants across 98 sites in 8 countries.
Detailed Summary
The purpose of this study is to compare the treatment effect of three treatment regimens of HDM-SPIRE vs placebo and to evaluates the treatment effect of HDM-SPIRE on symptoms, rescue medication usage, Quality of Life and Sleep Quality
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsRhinoconjunctivitis
CountriesCanada, France, Germany, Italy, Netherlands, South Africa, Spain, United States
CollaboratorsQuintiles, Inc.
Timeline
Phase 2CompletedFinished
201520162017201820192020202120222023202420252026
First PostedMay 2014
Enrollment StartSep 2014
Primary CompletionApr 2017
TodayJul 2026
First PostedMay 29, 2014
Enrollment StartSep 1, 2014
Primary CompletionApr 13, 2017
TodayJul 2, 2026
Enrollment to primary: 2.6 yearsPosted 12.1 years ago
Interventions
HDM-SPIREdrug
1 dose every 4 weeks
Placebodrug
1 dose every 4 weeks