Conditions: Asthma
Keywords: FLIXOTIDE asthmatics children 4-11 years SERETIDE asthma-control
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 506
Healthy volunteers: no

Brief summary:
This study will compare two treatment strategies (doubling the dose of inhaled steroids or adding a long acting beta2 agonist to the inhaled steroid at the same dose) in children not controlled by inhaled steroid alone at medium dose. The fixed combination SERETIDE 100/50 one inhalation twice daily will be compared to FLIXOTIDE 100 two inhalations twice daily.

Detailed description:
A multicentre, randomised, double-blind, double dummy, parallel group study to compare the salmeterol/fluticasone propionate combination (SERETIDE™) at a dose of 50/100mcg twice daily and fluticasone propionate (FLIXOTIDE™) at a dose of 200mcg twice daily, both delivered via a dry powder inhaler (DISKUS™) for 12 weeks in asthma in children aged 4-11 years not controlled by inhaled corticosteroids alone at medium dose

Arms:
arm 1: Fluticasone propionate (FLIXOTIDE™) at a dose of 200μg twice daily arm 2: Salmeterol/fluticasone propionate combination (SERETIDE™) at a dose of 50/100μg twice daily

Interventions: intervention 1: Fluticasone propionate intervention 2: Fluticasone propionate/salmeterol
Intervention descriptions: intervention 1: 200μg twice daily intervention 2: 50/100μg twice daily

Protocol document: