Ignite Creation Date:
2024-05-05 @ 4:50 PM
Last Modification Date:
2024-10-26 @ 9:25 AM
Study NCT ID:
NCT00328718
Status:
COMPLETED
Last Update Posted:
2017-01-20
First Post:
2006-05-19
Brief Title:
Pediatric ADVAIR DISKUS Versus Oral Montelukast Chewable Tablets
Sponsor:
GlaxoSmithKline
Organization:
GlaxoSmithKline
Study Overview
Official Title:
Randomised Double-blind Double-dummy Parallel-group Comparative Study of SalmeterolFP 50100mcg bd Inhalation Powder Via Diskus With Oral Montelukast 5mg QD Chewable Tablets in Children 6-14 Years
Status:
COMPLETED
Status Verified Date:
2017-01
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 is being conducted to demonstrate the superior clinical effectiveness of SalmeterolFluticasone Propionate compared to montelukast in the management of persistent asthma in children aged 6-14 years and to assess the effect of each treatment SalmeterolFluticasone Propionate 50100 mcg and montelukast 5 mg on lung function asthma control Health Outcomes including the childs quality of life as measured by Paediatric Asthma Quality of Life Questionnaire PAQLQ and the caregivers quality of life as measured by Paediatric Asthma Caregivers Quality of Life Questionnaire PACQLQ at selected centers where a valid translation is available
Detailed Description:
Pediatric Asthma Clinical Effectiveness study PEACE A Randomized Double-Blind Double Dummy Parallel Group comparative clinical study of SalmeterolFluticasone propionate Inhalation Powder 50100mcg BID via DISKUS with Oral montelukast 5mg QD Chewable Tablets in Children 6-14 years of Age with Persistent Asthma
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