At a glance
ClinicalIndex Comparison Record- ✓Age 6-12 years
- ✓Documented asthma history for at least 6 months
- ✓Bronchial hyperresponsiveness documented within 12 months prior or at visit 1
- ✓Prior inhaled corticosteroid use: BDP, budesonide up to 100-200 mcg twice daily, or fluticasone propionate up to 125 mcg twice daily for at least 4 weeks before run-in
- ✕Hospitalization for asthma within 4 weeks of visit 1
- ✕Upper respiratory tract infection within 2 weeks or lower respiratory tract infection within 4 weeks prior to visit 1
- ✕Oral, parenteral, or depot corticosteroids within 4 weeks prior to visit 1
- ✕Respiratory disorder other than asthma or systemic/thoracic abnormalities affecting lung function
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Multicentre, Randomised, Double-blind, Parallel Group Study to Compare the Efficacy and Safety of Salmeterol/Fluticasone Propionate Combination Product (Seretide®) 50/100 mcg With Fluticasone Propionate (Flixotide® ) 200 mcg, Both Delivered Twice Daily Via the DISKUS Inhaler, in the Treatment of Children Aged 6-12 Years With Symptomatic Asthma
In Brief
A Phase 4 clinical trial evaluating Salmeterol/ fluticasone propionate Diskus® inhaler 50/100 mcg and fluticasone propionate 2 x 100 mcg for Asthma. Completed, enrolled 176 participants across 18 sites.
Detailed Summary
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 Details
Timeline
Interventions
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