Ignite Creation Date:
2024-05-05 @ 4:47 PM
Last Modification Date:
2024-10-26 @ 9:24 AM
Study NCT ID:
NCT00315744
Status:
COMPLETED
Last Update Posted:
2017-10-19
First Post:
2006-04-17
Brief Title:
Viapaed Study In Children And Adolescents With Asthma
Sponsor:
GlaxoSmithKline
Organization:
GlaxoSmithKline
Study Overview
Official Title:
Steroid-sparing Management of the SalmeterolFluticasone 50100µg bid Combination Compared to Fluticasone 200µg bid in Children and Adolescents With Moderate Asthma
Status:
COMPLETED
Status Verified Date:
2017-10
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:
Asthmatic children who remain symptomatic on inhaled corticosteroids ICS require an adjustment of their asthma therapy Current guidelines suggest that the treatment options are either an increased dose of inhaled corticosteroid or the addition of other therapy such as a long-acting beta-agonist LABA In the pediatric age range major concerns with respect to high dose ICS therapy are growth retardation and the suppression of the hypothalamic-pituitary-adrenocortical HPA axis Previous studies in adults have shown that a combination product that included a LABA as well as the ICS allowed to reduce the steroid dose and was still at least as effective in achieving asthma control as treatment with a higher dose of ICS These treatment options shall be compared in the present study Children who remain symptomatic while inhaling 100 µg fluticasone FP twice daily shall be randomized to receive the salmeterol fluticasone combination product Viani SERETIDE 50100 µg or fluticasone 200 µg as a comparator drug inhaled twice daily via the DISKUS for a period of eight weeks
Detailed Description:
None
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