Ignite Creation Date:
2024-05-05 @ 4:57 PM
Last Modification Date:
2024-10-26 @ 9:26 AM
Study NCT ID:
NCT00353873
Status:
COMPLETED
Last Update Posted:
2018-05-29
First Post:
2006-07-18
Brief Title:
Seretide Versus Flixotide In Asthmatic Children Not Controlled By Inhaled Corticosteroids
Sponsor:
GlaxoSmithKline
Organization:
GlaxoSmithKline
Study Overview
Official Title:
A Multicentre Randomised Double-blind Double Dummy Parallel Group Study to Compare the SalmeterolFluticasone Propionate Combination SeretideTM at a Dose of 50100µg 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
Status:
COMPLETED
Status Verified Date:
2018-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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 10050 one inhalation twice daily will be compared to FLIXOTIDE 100 two inhalations twice daily
Detailed Description:
A multicentre randomised double-blind double dummy parallel group study to compare the salmeterolfluticasone propionate combination SERETIDE at a dose of 50100mcg twice daily and fluticasone propionate FLIXOTIDE at a dose of 200mcg twice daily both delivered via a dry powder inhaler DISKUS for 12 weeks in asthma in children aged 4-11 years not controlled by inhaled corticosteroids alone at medium dose
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None