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

• Status: Completed
• Trial end date: 2007-12-01
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: GlaxoSmithKline
• Treatments: Fluticasone; Fluticasone Propionate, Salmeterol Xinafoate Drug Combination; Salmeterol Xinafoate; Xhance

Criteria

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