At a glance
ClinicalIndex Comparison RecordPhase 2Completed· 26 enrolled
Drug / intervention
Fluticasone Furoate +1 moredrug
Likely dose
Fluticasone Furoate 100mcgfrom 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, Double-blind, Repeat Dose, Two Period Crossover Study to Evaluate the Safety and Tolerability, Pharmacokinetics, and Pharmacodynamics of Inhaled Fluticasone Furoate/Vilanterol 100/25 Micrograms in Children Aged 5 to 11 Years With Persistent Asthma
In Brief
A Phase 2 clinical trial evaluating Fluticasone Furoate and Fluticasone Furoate/Vilanterol for Asthma. Completed, enrolled 26 participants across 1 site.
Detailed Summary
This study will investigate the safety and tolerability, pharmacokinetics, and pharmacodynamics of fluticasone furoate/vilanterol (FF/VI) 100/25mcg administered using the novel dry powder inhaler in children aged 5 to 11 years with persistent asthma.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsAsthma
CountriesUnited States
Collaborators--
Timeline
Phase 2CompletedFinished
201220132014201520162017201820192020202120222023202420252026
Enrollment StartOct 2011
First PostedOct 2011
Primary CompletionJun 2012
TodayJul 2026
First PostedOct 17, 2011
Enrollment StartOct 1, 2011
Primary CompletionJun 1, 2012
TodayJul 2, 2026
Enrollment to primary: 8 monthsPosted 14.7 years ago
Interventions
Fluticasone Furoatedrug
100mcg delivered via a novel dry powder inhaler on days 1-14 of one study treatment period.
Fluticasone Furoate/Vilanteroldrug
100/25 mcg delivered via a novel dry powder inhaler on days 1-14 of one study treatment period.