At a glance
ClinicalIndex Comparison RecordPhase 4Completed· 506 enrolled
Drug / intervention
Fluticasone propionate +1 moredrug
Likely dose
Fluticasone propionate 200μgfrom 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 Multicentre, Randomised, Double-blind, Double Dummy, Parallel Group Study to Compare the Salmeterol/Fluticasone Propionate Combination (SeretideTM) at a Dose of 50/100µg Twice Daily and Fluticasone Propionate (FlixotideTM) at a Dose of 200µg Twice Daily, Both Delivered Via a Dry Powder Inhaler (DiskusTM) for 12 Weeks in Asthma in Children Aged 4-11 Years Not Controlled by Inhaled Corticosteroids Alone at Medium Dose
In Brief
A Phase 4 clinical trial evaluating Fluticasone propionate and Fluticasone propionate/salmeterol for Asthma. Completed, enrolled 506 participants across 65 sites in 12 countries.
Detailed Summary
This study will compare two treatment strategies (doubling the dose of inhaled steroids or adding a long acting beta2 agonist to the inhaled steroid at the same dose) in children not controlled by inhaled steroid alone at medium dose. The fixed combination SERETIDE 100/50 one inhalation twice daily will be compared to FLIXOTIDE 100 two inhalations twice daily.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsAsthma
CountriesBelgium, Denmark, France, Italy, Latvia, Lithuania, Netherlands, Norway, Poland, Russia, Spain, Sweden
Collaborators--
Timeline
Phase 4CompletedFinished
2006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
Enrollment StartNov 2005
First PostedJul 2006
Primary CompletionOct 2006
TodayJul 2026
First PostedJul 19, 2006
Enrollment StartNov 18, 2005
Primary CompletionOct 26, 2006
TodayJul 2, 2026
Enrollment to primary: 11 monthsPosted 20.0 years ago
Interventions
Fluticasone propionatedrug
200μg twice daily
Fluticasone propionate/salmeteroldrug
50/100μg twice daily