SERETIDE 100/50 bd (Twice Daily) Versus FLIXOTIDE 100 bd As Initial Maintenance Therapy In Moderate Asthma In Adults

Seretide 100 DK vs Flixotide 100 DK in IMT in Moderate Asthma in Adults on Static Lung Volumes (Mechanistic Study)

This study will compare during 12 weeks, two treatment strategies for Initial Maintenance Therapy : fluticasone propionate alone or the salmeterol/fluticasone propionate combination in adults with moderate persistent asthma

A multicentre randomised, double-blind, parallel-group study to compare the salmeterol/fluticasone propionate combination (SERETIDETM DISKUSTM 50/100) 50/100µg one inhalation twice daily with fluticasone propionate (FLIXOTIDETM DISKUSTM 100) 100µg one inhalation twice daily as initial maintenance therapy for 12 weeks in adults with persistent moderate asthma

Inclusion criteria:

• male or female ≥ 18
• documented history of asthma
• reversibility FEV1 or PEF ≥ 12% (post 400µg salbu)
• moderate asthma (daily symptoms, daily rescue use, PEF = 60-80% predicted value)
• naive or ≥ 4weeks-free ICS (inhaled corticosteroids)

Exclusion criteria:

• respiratory disorder
• FEV1<60% predicted
• exacerbation/respiratory infection ≤ 4 weeks
• oral/parenteral/depot corticosteroids ≤ 6 months
• LABA/oral β2 agonist/ ALT/ theophylline ≤ 4 weeks
• smoker or former smoker ≥ 5 packs year