Conditions: Asthma
Keywords: salmeterol/fluticasone combination Asthma bronchial hyperresponsiveness Children symptom control
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 176
Healthy volunteers: no

Brief 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.

Detailed description:
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.

Arms:
arm 1: Salmeterol/ fluticasone propionate Diskus® inhaler 50/100 mcg arm 2: fluticasone propionate 2 x 100 mcg

Interventions: intervention 1: Salmeterol/ fluticasone propionate Diskus® inhaler 50/100 mcg intervention 2: fluticasone propionate 2 x 100 mcg
Intervention descriptions: intervention 1: comparator intervention 2: comparator

Protocol document: