CONCEPT: A 1-Year Comparison Of A Stable Dose Of SERETIDE With An Adjustable Maintenance Dose Of SYMBICORT - Full Text View

Sponsor:	GlaxoSmithKline
Information provided by:	GlaxoSmithKline
ClinicalTrials.gov Identifier:	NCT00479739

Purpose

To compare a stable dose of salmeterol/fluticasone propionate with a variable dose of formoterol/budesonide where the dose is adjusted according to a physician-guided self-management plan

Condition	Intervention	Phase
Asthma	Drug: Salmeterol/fluticasone propionate or formoterol/budesonide	Phase IV

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

Resource links provided by NLM:

MedlinePlus related topics: Asthma

Drug Information available for: Formoterol fumarate Budesonide Arformoterol Formoterol Fluticasone propionate Salmeterol Fluticasone Salmeterol xinafoate Arformoterol Tartrate

U.S. FDA Resources

Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:

Mean percentage of symptom-free days over a 52-week treatment period

Secondary Outcome Measures:

Mean percentage of rescue-free days Daily asthma symptom scores Daily rescue usage Mean morning peak flow Percentage of nights awoken due to asthma Rate of exacerbations Airway hyper-responsiveness(PC20 AMP)

Estimated Enrollment:	700
Study Start Date:	November 2002

Detailed Description:

A randomised, double-blind, double-dummy, 52-week, parallel group study of a standard dosing regimen with salmeterol/fluticasone propionate combination 50/250mcg bid (via the DISKUS/ACCUHALER inhaler) versus a symptom-driven variable dosing regimen with formoterol/budesonide combination 6/200mcg (via a breath-actuated dry powder reservoir inhaler)in adults asthmatics

Eligibility

Ages Eligible for Study:	18 Years to 70 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Documented clinical history of asthma
Forced expiratory volume in 1 second between 60% and 90% of predicted
Using an inhaled corticosteroid (ICS)at a dose equivalent to 200 to 500 mcg daily of beclomethasone (BDP)or equivalent combined with a long-acting beta-2-agonist or an ICS alone at a dose equivalent to >500 to 1000mcg daily of BDP daily

Exclusion Criteria:

Lower respiratory tract infection within 1 month of study entry
Use of systemic corticosteroids within 1 month of study entry
Smoking history of 10 pack years or more Changes in regular asthma therapy within 12 weeks of study entry
Any significant disorder that in the investigator's opinion might put the patient at risk or influence the study outcomes

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00479739

Show 104 Study Locations

Sponsors and Collaborators

GlaxoSmithKline

Investigators

Study Director:

GSK Clinical Trials, MD

GlaxoSmithKline

More Information

No publications provided by GlaxoSmithKline

Additional publications automatically indexed to this study by National Clinical Trials Identifier (NCT ID):

Price DB, Williams AE, Yoxall S. Salmeterol/fluticasone stable-dose treatment compared with formoterol/budesonide adjustable maintenance dosing: impact on health-related quality of life. Respir Res. 2007 Jul 4;8:46.

Responsible Party:	GSK ( Study Director )
Study ID Numbers:	SAM40056
Study First Received:	May 25, 2007
Last Updated:	February 19, 2009
ClinicalTrials.gov Identifier:	NCT00479739 History of Changes
Health Authority:	Canada: Health Canada; Spain: Ethics Committee

Keywords provided by GlaxoSmithKline:

Salmeterol/fluticasone propionate
formoterol/budesonide
adjustable maintenance dosing
asthma control
exacerbations

Additional relevant MeSH terms:

Anti-Inflammatory Agents
Respiratory System Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Adrenergic Agents
Bronchial Diseases
Physiological Effects of Drugs
Hormones, Hormone Substitutes, and Hormone Antagonists
Hormones
Adrenergic Agonists
Hypersensitivity
Lung Diseases, Obstructive
Respiratory Tract Diseases
Therapeutic Uses
Fluticasone

Formoterol
Dermatologic Agents
Salmeterol
Adrenergic beta-Agonists
Immune System Diseases
Budesonide
Asthma
Anti-Asthmatic Agents
Anti-Allergic Agents
Glucocorticoids
Pharmacologic Actions
Autonomic Agents
Lung Diseases
Hypersensitivity, Immediate
Peripheral Nervous System Agents

ClinicalTrials.gov processed this record on February 08, 2010