SERETIDE 100/50 bd Versus FLIXOTIDE 100 bd As Initial Maintenance Therapy In Moderate Asthma In Adults

Condition(s) targeted: Asthma Adults

Intervention: SERETIDE FLIXOTIDE (Drug)

Phase: Phase 4

Status: Terminated

Sponsored by: GlaxoSmithKline

Official(s) and/or principal investigator(s):
GSK Clinical Trials, MD, Study Director, Affiliation: GlaxoSmithKline

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

Official title: 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

Study design: Treatment, Randomized, Double-Blind, Active Control, Parallel Assignment, Efficacy Study

Primary outcome: to demonstrate that salmeterol/fluticasone propionate combination 50/100µg DISKUS (SFC100) is more effective than fluticasone propionate 100µg DISKUS (FP100) on PEF, in the initial maintenance therapy in persistent moderate asthma

Secondary outcome:

To demonstrate that SFC100 bd is more effective than FP100 bd on FEV1 and on time to reach first week of asthma control. To demonstrate in a sub-group of patients, that SFC100 bd is more effective than FP100 bd, in reducing air trapping.

pre-dose FEV1 ; FVC ; FEF25-75% ; asthma control ; Daily Record Card assessment ; exacerbations ; ACT ; CT-scan ; safety ; AQLQ

Minimum age: 18 Years. Maximum age: 40 Years. Gender(s): Both.

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

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 ≥ 5PY

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Starting date: March 2007
Ending date: December 2007
Last updated: February 28, 2008