At a glance
ClinicalIndex Comparison RecordPhase 4Completed· 454 enrolled
Drug / intervention
Bilastine 20mg +3 moredrug
Likely dose
Bilastine 20mgfrom 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.
Bilastine and Montelukast in Patients With Seasonal Allergic Rhinoconjunctivitis and Asthma: Efficacy of Concomitant Administration - the SKY Study
Menarini International Operations Luxembourg SA·interventional·Posted May 4, 2016·Updated Jul 12, 2019
In Brief
A Phase 4 clinical trial evaluating Bilastine 20mg, Montelukast 10mg, and 2 other interventions for Seasonal Allergic Rhinoconjunctivitis and Asthma. Completed, enrolled 454 participants across 32 sites in 8 countries.
Detailed Summary
The purpose of this study is to compare concomitant administration of Montelukast and Bilastine to Montelukast and Bilastine monotherapies in patients with SARC and asthma
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsSeasonal Allergic Rhinoconjunctivitis, Asthma
CountriesCroatia, Czechia, Germany, Italy, Latvia, Poland, Romania, Slovakia
Collaborators--
Timeline
Phase 4CompletedFinished
20162017201820192020202120222023202420252026
Enrollment StartApr 2016
First PostedMay 2016
Primary CompletionNov 2016
TodayJul 2026
First PostedMay 4, 2016
Enrollment StartApr 13, 2016
Primary CompletionNov 24, 2016
TodayJul 2, 2026
Enrollment to primary: 7 monthsPosted 10.2 years ago
Interventions
Bilastine 20mgdrug
Montelukast 10mgdrug
Placebo Bilastine 20mgdrug
Placebo Montelukast 10mgdrug