CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 27 enrolled
Drug / intervention
Fluticasone furoate +1 moredrug
Likely dose
Fluticasone furoate 100µgfrom 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.

Search/NCT01332292
NCT01332292Phase 2Completed
CompareCT.gov

A Randomized, Double-blind, Placebo-controlled, Two-way Crossover 14-day Study to Investigate the Safety, Tolerability, Pharmacodynamics and Pharmacokinetics of Repeat Dose Inhaled Fluticasone Furoate 100ug (Micrograms) in Children Aged 5-11 Years With Persistent Asthma

GlaxoSmithKline·interventional·Posted Apr 11, 2011·Updated Mar 23, 2017

In Brief

A Phase 2 clinical trial evaluating Fluticasone furoate and Matching placebo for Asthma. Completed, enrolled 27 participants across 5 sites.

Detailed Summary

This study will investigate the effect of dosing with flutucasone furoate in asthmatic subjects aged 5-11 years of age. A randomized, two-way crossover, with placebo control, over a 14 day treatment period, it will investigate safety, tolerability, pharmacokinetics and serum cortisol levels.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsAsthma
CountriesUnited States
Collaborators--

Timeline

Phase 2CompletedFinished
20102011201220132014201520162017201820192020202120222023202420252026
First PostedApr 11, 2011
Enrollment StartMay 1, 2010
Primary CompletionJan 1, 2011
TodayJul 2, 2026
Enrollment to primary: 8 monthsPosted 15.2 years ago

Interventions

Fluticasone furoatedrug

Novel dry powder inhaler: 100µg per blister One blister strip containing fluticasone furoate micronised drug blended with lactose and a second blister strip containing lactose and magnesium stearate.

Matching placebodrug

Novel dry powder inhaler: One blister strip containing lactose and a second blister strip containing lactose and magnesium stearate.