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”

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

Study Type: Interventional

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

Study Primary Completion Date: December 2007

Intervention(s) in this Clinical Trial

• Drug: SERETIDE FLIXOTIDE

Primary Measures

• 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 Measures

• 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

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

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 18 Years

Maximum Age for this Clinical Trial: 40 Years

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Sponsor: GlaxoSmithKline

Overall Clinical Trial Officials and Contacts

GSK Clinical Trials, MD Study Director GlaxoSmithKline  

Information obtained from ClinicalTrials.gov on October 07, 2008

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00461500

Study ID Number: SAM108037

ClinicalTrials.gov Identifier: NCT00461500

Health Authority: France: Afssaps - French Health Products Safety Agency