Official Title: “Comparison of Stepwise Treatment of Asthmatic Children With Salmeterol/Fluticasone Propionate Combination Product (Seretide®) and/or Fluticasone Propionate (Flixotide®) Based on PD20 Methacholine and Symptoms or Based on Symptoms Only (Children Asthma Therapy Optimal)”

This study was designed to evaluate if, in children with asthma, a stepwise treatment (five levels varying from once daily fluticasone propionate 100mcg until twice daily a fixed combination of salmeterol and fluticasone propionate 50/500 mcg) based on symptom scores alone results in a sub-optimal treatment when compared to treatment based on cumulative symptom scores and bronchial hyperresponsiveness (PD20 methacholine).

Study Type: Interventional

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

Intervention(s) in this Clinical Trial

• Drug: Salmeterol/Fluticasone propionate combination product
• Drug: Fluticasone propionate

Primary Measures

• Asthma symptom free days during the last 12 weeks of the treatment period.

Secondary Measures

• Bronchial hyperresponsiveness, determined by PD20 methacholine at the end of the study.

Inclusion criteria:

• Children with a documented history of asthma.
• Using inhaled steroids from 100 mcg up to 500 mcg twice daily for at least 1 month before study start.
• Must be able to perform reproducible lung function tests.
• Must have a positive RAST or skin prick test.
• During the treatment period, the patient has to be hyperreactive (defined as PD20 methacholine < 150 mcg) and/or have a cumulative symptom score of 14 based on the daily record card filled in during the last 2 weeks of the run-in period.

Exclusion criteria:

• History of an acute upper or lower respiratory tract infection, middle ear, or sinus infection 4 weeks prior to visit 1.
• Admitted to hospital due to a respiratory disease 4 weeks prior to visit 1.
• Received oral corticosteroids within 4 weeks prior to visit 1.
• Existence of any disorder that affects growth.
• Clinical or laboratory evidence of a serious systemic disease, or suspected hypersensitivity to corticosteroids, lactose or short/long acting B2-agonists.

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 6 Years

Maximum Age for this Clinical Trial: 16 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 February 04, 2010

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00158834

Study ID Number: SAS30018

ClinicalTrials.gov Identifier: NCT00158834

Health Authority: Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)