Official Title: “A Multicentre, Randomised, Double Blind, Parallel Group Study to Compare the Efficacy and Safety of Salmeterol/Fluticasone Propionate Combination Product (Seretide®) 50/100mcg With Fluticasone Propionate (Flixotide®) 200mcg, Both Delivered Twice Daily Via the DISKUS Inhaler, in the Treatment of Children Aged 6-12 Years With Symptomatic Asthma.”

This study is being conducted to investigate whether in childhood salmeterol/ fluticasone propionate 50/100 bd delivered via the Diskus® inhaler and fluticasone propionate 200 mcg bd delivered via the Diskus® inhaler are non- inferior in terms of symptom control.

Additionally we aim to show that salmeterol/ fluticasone propionate 50/100 bd is at least as good in terms of lung function improvement and bronchial hyperreactivity and enables a steroid-sparing management of asthma in children.

Study Type: Interventional

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

Study Primary Completion Date: November 2008

Intervention(s) in this Clinical Trial

• Drug: Salmeterol/ fluticasone propionate Diskus® inhaler 50/100 mcg
• Drug: fluticasone propionate 2 x 100 mcg

Primary Measures

• Symptom-free days after 26 weeks.

Secondary Measures

• Percentage asthma symptom-free days during 26 weeks. Lung function bronchial hyperresponsiveness
• • Percentage asthma symptom free days during 26 weeks • Weekly mean symptom score during 26 weeks • Lung function: FEV1, FEV 0.5, FVC, MEF50
• • Lung function : Rint in selected centres • NO measurements in exhaled air in selected centres • Bronchial hyperresponsiveness with PD20 methacholine
• • Bronchial hyperresponsiveness with PD20 AMP in selected centres • Daily FEV1 and PEF via the electronic peakflow /FEV1 meter (PIKO-1) • Frequency of asthma exacerbations (discriminated on severity)
• • Weekly % of subjects with symptom free weeks and the cumulative number of symptom free weeks until the end of treatment
• • Weekly % of subjects with 'good controlled weeks' and 'maximal controlled weeks' and the cumulative number of symptom free weeks until the end of treatment.
• • Time to asthma control, defined as the time to first 'good controlled week' or 'maximum controlled week. Safety • Adverse events and serious adverse events
• • Oropharyngeal examination • Height by stadiometry (including height history) • 12-hours urine cortisol

Inclusion criteria:

• Male or female subjects aged 6-12 years (inclusive)
• A female is eligible to enter and participate in the study if she is:
• of non-child-bearing potential; OR of child-bearing potential, but not lactating and pregnant. She declares that it is not probable that she will become pregnant during the study (a pregnancy test can be performed at the investigators discretion)
• Subjects with a documented history of asthma for at least 6 months
• Subjects with a documented history of BHR within 12 months prior to inclusion or BHR on visit 1 (PD20 methacholine < 150 mcg or an equivalence for histamine)
• Subjects who have received BDP, budesonide up to 100-200 mcg bd or fluticasone propionate at a dose of up to 125 mcg bd for at least 4 weeks before the start of the run-in period.
• Subjects who are able to use a electronic peakflow /FEV1 meter (PIKO-1)
• Subjects who have a normal length SD score between -2SD and +2SD
• Subjects who are able to use a Diskus inhaler
• Subjects who are able to perform reproducible lung function tests at visit 1 (variation FEV1 < 5% between the two best measurements)
• Subjects and their guardians, who have given written informed consent to participate in the study
• Subjects or their parent/ guardian who are able to understand and complete a DRC. The DRC may be completed by a parent/guardian if the subject is unable to do this him/ herself
• Subjects able to use Ventolin on an 'as required for symptoms' basis

Exclusion criteria:

• Subjects who have been hospitalised for their asthma within 4 weeks of visit 1
• Subjects who had an acute upper respiratory tract infection within 2 weeks or a lower respiratory tract infection within 4 weeks prior to visit 1
• Subjects who received oral, parental or depot corticosteroids within 4 weeks prior to visit 1
• Subjects who have a known respiratory disorder other than asthma and/or systemic/thoracic abnormalities which influence normal lung function
• Subjects with a disorder that affects growth (e.g. Turner's syndrome)
• Subjects who have received any investigational drugs within 4 weeks of visit 1
• Subjects with a known or suspected hypersensitivity to inhaled steroids, β2-agonists or lactose
• Subjects who use any medication that significantly inhibit the cytochrome P450 subfamily enzyme CYP3A4, including ritonavir and ketoconazole
• Subjects who concurrently participate in another clinical study
• Subjects who have previously been randomised in this trial

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 6 Years

Maximum Age for this Clinical Trial: 12 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 October 10, 2008

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00197106

Study ID Number: SAM101667

ClinicalTrials.gov Identifier: NCT00197106

Health Authority: Netherlands: Medicines Evaluation Board (MEB)