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

GlaxoSmithKline (GSK)

Status and phase: Completed; Phase 4

Conditions: Asthma

Treatments: Drug: Fluticasone propionate; Drug: Salmeterol xinafoate/fluticasone propionate combination

Study type: Interventional

Funder types: Industry

Identifiers

NCT00461500

SAM108037

Details and patient eligibility

About

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

Full description

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

Enrollment: 81 patients

Sex: All

Ages: 18 to 40 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind