Airway Hyper-Responsiveness Study In Asthma Using Salmeterol/Fluticasone Propionate Combination Product - Full Text View

Purpose

This double-blind, stratified, parallel group study is to determine whether aiming for 'Total control' results in better airway hyper-responsiveness than maintaining the treatment level at which 'Well-controlled' asthma was achieved. The primary endpoint is the mean change in PC20 methacholine. Well controlled subjects (as assessed after a 12 week run-in period) will enter a 24 week treatment period during which they will record PEF(Peak Expiratory Flow), symptoms, rescue beta2-agonist use over 24 hours, night time awakenings, asthma exacerbations, emergency visits due to asthma and Adverse Events. At every visit lung function measurements and airway hyper-responsiveness will be measured.

Condition	Intervention	Phase
Asthma	Drug: Salmeterol/fluticasone propionate combination	Phase IV

MedlinePlus related topics:

Asthma

Drug Information available for:

Fluticasone Fluticasone propionate Salmeterol Salmeterol xinafoate

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double-Blind, Parallel Assignment, Efficacy Study

Official Title:	See Detailed Description

Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:

Mean change in PC20 methacholine (as a measure of airway hyper-responsiveness) following 24 weeks of treatment.

Secondary Outcome Measures:

Number of 'Totally-controlled' and Well-controlled patients at the end of the run-in and treatment period according to the GOAL criteria.

Estimated Enrollment:	150
Study Start Date:	November 2005

Detailed Description:

A multi-centre, randomised, double blind, stratified, and parallel group study to evaluate whether a treatment strategy based on aiming for 'Total control' results in better airway hyper-responsiveness than a treatment strategy based on maintaining the treatment level at which 'Well-controlled' asthma was achieved.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion criteria:

History of asthma of at least 6 months.
Subjects who have received fluticasone propionate at a dose of 100 mcg bd to 250 mcg bd or equivalent with or without a long acting beta2-agonist for at least 4 weeks before the start of the run-in period, at a constant dose.
Subjects who are able to understand and complete an electronic diary card.

Exclusion criteria:

Subjects who have been hospitalized for their asthma within 4 weeks of study entry.
Subjects who had an acute upper respiratory tract infection within 4 weeks or a lower respiratory tract infection within 4 weeks prior to study entry.
Subjects who received oral, parental or depot corticosteroids within 4 weeks prior to study entry.
Subjects who have a known respiratory disorder other than asthma and/or systemic/thoracic abnormalities which influence normal lung function.
Subjects who have more than 5 pack years.
Subjects who currently smoke.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00291382

Show 37 Study Locations

Sponsors and Collaborators

GlaxoSmithKline

Investigators


Study Director:	GSK Clinical Trials, MD	GlaxoSmithKline

More Information

Responsible Party:	GSK ( Study Director )
Study ID Numbers:	SAM49071
First Received:	February 13, 2006
Last Updated:	October 13, 2008
ClinicalTrials.gov Identifier:	NCT00291382
Health Authority:	Germany: Federal Institute for Drugs and Medical Devices

Keywords provided by GlaxoSmithKline:

Asthma

adult

Total asthma control

airway hyper-responsiveness

Study placed in the following topic categories:

Hypersensitivity

Lung Diseases, Obstructive

Salmeterol

Respiratory Tract Diseases

Lung Diseases

Hypersensitivity, Immediate

Fluticasone

Hyperkinesis

Asthma

Respiratory Hypersensitivity

Additional relevant MeSH terms:

Anti-Inflammatory Agents

Respiratory System Agents

Neurotransmitter Agents

Bronchial Diseases

Immune System Diseases

Adrenergic beta-Agonists

Adrenergic Agents

Molecular Mechanisms of Pharmacological Action

Physiological Effects of Drugs

Anti-Asthmatic Agents

Anti-Allergic Agents

Adrenergic Agonists

Pharmacologic Actions

Autonomic Agents

Therapeutic Uses

Peripheral Nervous System Agents

Dermatologic Agents

Bronchodilator Agents

ClinicalTrials.gov processed this record on October 31, 2008

Sponsored by:	GlaxoSmithKline
Information provided by:	GlaxoSmithKline
ClinicalTrials.gov Identifier:	NCT00291382