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 4

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double-Blind Primary Purpose: Treatment
Official Title:	See Detailed Description

Resource links provided by NLM:

MedlinePlus related topics: Asthma

Drug Information available for: Formoterol fumarate Budesonide 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

Intervention Details:

Other Name: Salmeterol/fluticasone propionate or formoterol/budesonide

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

Publications:

Price D, Williams AE, Yoxall S. Quality of life of stable dose treatment with salmeterol/fluticasone compared with adjustable maintenance dosing with formoterol/budesonide. European Respiratory Journal Supplement 2005; 26(Suppl. 49): 252 (plus poster) abstr. P1720.

Fitzgerald M, Boulet LP, Pieters WR. Improved control of symptoms and exacerbations with stable dose treatment with salmeterol/fluticasone propionate compared with adjustable maintenance dosing with formoterol/budesonide. European Respiratory Journal Supplement 2005; 26: 429.

Boulet LP, Fitzgerald M, Pieters R. The CONCEPT study: comparative influence of two treatment strategies on airway response to AMP. European Respiratory Journal Supplement 2005; 26: 429.

FitzGerald JM, Boulet LP, Follows RM. The CONCEPT trial: a 1-year, multicenter, randomized,double-blind, double-dummy comparison of a stable dosing regimen of salmeterol/fluticasone propionate with an adjustable maintenance dosing regimen of formoterol/budesonide in adults with persistent asthma. Clin Ther. 2005 Apr;27(4):393-406.

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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:	Cheri Hudson; Clinical Disclosure Advisor, GSK Clinical Disclosure
ClinicalTrials.gov Identifier:	NCT00479739 History of Changes
Other Study ID Numbers:	SAM40056
Study First Received:	May 25, 2007
Last Updated:	March 17, 2011
Health Authority:	Canada: Health Canada Spain: Ethics Committee

Keywords provided by GlaxoSmithKline:

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

Additional relevant MeSH terms:

Asthma
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases
Budesonide
Formoterol
Salmeterol
Fluticasone
Bronchodilator Agents
Autonomic Agents

Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Anti-Asthmatic Agents
Respiratory System Agents
Therapeutic Uses
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Anti-Inflammatory Agents
Adrenergic beta-2 Receptor Agonists
Adrenergic beta-Agonists
Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents

ClinicalTrials.gov processed this record on May 24, 2012