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

Tracking Information

First Received Date ^ICMJE

April 17, 2007

Last Updated Date

October 13, 2008

Start Date ^ICMJE

March 2007

Primary Completion Date

December 2007 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

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

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT00461500 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

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

Original Secondary Outcome Measures ^ICMJE

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.

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

See Detailed Description

Brief 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

Detailed 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

Study Phase

Phase IV

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

Treatment, Randomized, Double-Blind, Parallel Assignment, Efficacy Study

Condition ^ICMJE

Asthma

Intervention ^ICMJE

Drug: SERETIDE FLIXOTIDE

Study Arms / Comparison Groups

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

310

Completion Date

December 2007

Primary Completion Date

December 2007 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Both

Ages

18 Years to 40 Years

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

Administrative Information

NCT ID ^ICMJE

NCT00461500

Responsible Party

Study Director, GSK

Study ID Numbers ^ICMJE

SAM108037

Study Sponsor ^ICMJE

GlaxoSmithKline

Collaborators ^ICMJE

Investigators ^ICMJE

Study Director:

GSK Clinical Trials, MD

GlaxoSmithKline

Information Provided By

GlaxoSmithKline

Verification Date

October 2008

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP