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.”

Comparison of two asthma treatments by lung function measures.

Study Type: Interventional

Study Design: Treatment, Randomized, Double-Blind, Parallel Assignment, Efficacy Study

Intervention(s) in this Clinical Trial

• Drug: Salmeterol/fluticasone propionate
• Drug: Fluticasone propionate

Primary Measures

• sRAW (k.Pa.s) measured before the study medication dose at the end of treatment (week 6)

Secondary Measures

• 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.

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.

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 4 Years

Maximum Age for this Clinical Trial: 11 Years

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Sponsor: GlaxoSmithKline

Overall Clinical Trial Officials and Contacts

GSK Clinical Trials, MD Study Director GlaxoSmithKline  

Information obtained from ClinicalTrials.gov on July 02, 2009

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00169546

Study ID Number: SAM40100

ClinicalTrials.gov Identifier: NCT00169546

Health Authority: United Kingdom: Medicines and Healthcare Products Regulatory Agency