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

Sponsor:	GlaxoSmithKline
Information provided by:	GlaxoSmithKline
ClinicalTrials.gov Identifier:	NCT00461500

Purpose

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

Condition	Intervention	Phase
Asthma	Drug: SERETIDE FLIXOTIDE	Phase IV

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double-Blind, Parallel Assignment, Efficacy Study
Official Title:	See Detailed Description

Resource links provided by NLM:

MedlinePlus related topics: Asthma

Drug Information available for: Fluticasone propionate Fluticasone Advair

U.S. FDA Resources

Further study details as provided by GlaxoSmithKline:

Primary Outcome 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 Outcome 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

Estimated Enrollment:	310
Study Start Date:	March 2007
Study Completion Date:	December 2007
Primary Completion Date:	December 2007 (Final data collection date for primary outcome measure)

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

Eligibility

Ages Eligible for Study:	18 Years to 40 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00461500

Sponsors and Collaborators

GlaxoSmithKline

Investigators

Study Director:

GSK Clinical Trials, MD

GlaxoSmithKline

More Information

No publications provided

Responsible Party:	GSK ( Study Director )
Study ID Numbers:	SAM108037
Study First Received:	April 17, 2007
Last Updated:	October 13, 2008
ClinicalTrials.gov Identifier:	NCT00461500 History of Changes
Health Authority:	France: Afssaps - French Health Products Safety Agency

Keywords provided by GlaxoSmithKline:

persistent
moderate
asthma
adults

Initial
Maintenance
Therapy

Additional relevant MeSH terms:

Anti-Inflammatory Agents
Respiratory System Agents
Bronchial Diseases
Immune System Diseases
Physiological Effects of Drugs
Anti-Asthmatic Agents
Asthma
Anti-Allergic Agents
Pharmacologic Actions
Lung Diseases, Obstructive
Hypersensitivity

Respiratory Tract Diseases
Autonomic Agents
Therapeutic Uses
Lung Diseases
Hypersensitivity, Immediate
Fluticasone
Peripheral Nervous System Agents
Dermatologic Agents
Bronchodilator Agents
Respiratory Hypersensitivity

ClinicalTrials.gov processed this record on November 09, 2009