Study In Airway Physiology In Children
Information source: GlaxoSmithKline
Information obtained from ClinicalTrials.gov on August 06, 2007
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Asthma
Intervention: Salmeterol/fluticasone propionate (Drug); Fluticasone propionate (Drug)
Phase: Phase 4
Status: Recruiting
Sponsored by: GlaxoSmithKline Official(s) and/or principal investigator(s):
GSK Clinical Trials, MD, Study Director, Affiliation: GlaxoSmithKline
Summary
Comparison of two asthma treatments by lung function measures.
Clinical Details
Official title:
Comparator Study to Demonstrate Superiority of Salmeterol/Fluticasone Propionate 50/100mcg bd Over Fluticasone Propionate 200mcg bd With Respect to Airway Physiology in Children Treated for 6 Weeks.
Study design: Interventional, Treatment, Randomized, Double-Blind, Active Control, Parallel Assignment, Efficacy Study
Primary outcome: sRAW (k.Pa.s) measured before the study medication dose at the end of treatment (week 6)
Secondary outcome: sRAW measured pre-dose at Week 3.
sRAW measured 48 hours after last study medication dose.
% symptom-free days over Weeks 1-6.
% symptom-free nights over Weeks 1-6.
Type and frequency of adverse events.
Eligibility
Minimum age: 4 Years.
Maximum age: 11 Years.
Gender(s): Both.
Criteria:
Inclusion criteria:
- Currently receiving 200-800mcg/day beclomethasone dipropionate.
- sRAW value of 1. 3 kPa's.
Exclusion Criteria:
- 3 or more courses of oral steroids in last 12 months.
Locations and Contacts
GSK Clinical Trials Call Center, Wellington 10055, New Zealand; Recruiting
GSK Clinical Trials Call Center, Phone: 1-877-379-3718
GSK Clinical Trials Call Center, Manchester M23 9GP, United Kingdom; Recruiting
GSK Clinical Trials Call Center, Phone: 1-877-379-3718
Additional Information
Starting date:
October 2003
Last updated: May 3, 2007
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