Airway Hyper-responsiveness Study In Asthma Using Salmeterol/Fluticasone Propionate Combination Product

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ClinicalTrials.gov Identifier: NCT00291382

Recruitment Status : Completed

First Posted : February 14, 2006

Last Update Posted : May 30, 2017

Sponsor:

Information provided by (Responsible Party):

GlaxoSmithKline

Study Description

Brief Summary:

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 or disease	Intervention/treatment	Phase
Asthma	Drug: Salmeterol/fluticasone propionate combination	Phase 4

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.

Study Design

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Study Type :	Interventional (Clinical Trial)
Actual Enrollment :	150 participants
Allocation:	Randomized
Intervention Model:	Parallel Assignment
Masking:	Double
Primary Purpose:	Treatment
Official Title:	A Multicentre, Stratified, Randomised, Double Blind, Parallel Group Trial to Evaluate Whether a Treatment Strategy Based on Aiming for Total Control Results in Better AHR Than a Treatment Strategy Based on Maintaining Well Control
Actual Study Start Date :	November 2005
Actual Primary Completion Date :	July 2007
Actual Study Completion Date :	July 2007

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Asthma

Drug Information available for: Fluticasone propionate Salmeterol Fluticasone Salmeterol xinafoate Fluticasone furoate

U.S. FDA Resources

Arms and Interventions

Outcome Measures

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.

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:	18 Years and older (Adult, Older Adult)
Sexes Eligible for Study:	All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00291382

Locations

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Belgium
GSK Investigational Site
Gent, Belgium, 9000
GSK Investigational Site
Liège, Belgium, 4000
Estonia
GSK Investigational Site
Tartu, Estonia, 51014
Finland
GSK Investigational Site
Jyvaskyla, Finland, 40100
GSK Investigational Site
Tampere, Finland, 33100
France
GSK Investigational Site
Lille cedex, France, 59042
GSK Investigational Site
Montpellier, France, 34295
GSK Investigational Site
Poitiers, France, 86000 cedex
Germany
GSK Investigational Site
Sinsheim, Baden-Wuerttemberg, Germany, 74889
GSK Investigational Site
Bonn, Nordrhein-Westfalen, Germany, 53123
GSK Investigational Site
Berlin, Germany, 10559
GSK Investigational Site
Berlin, Germany, 13353
GSK Investigational Site
Berlin, Germany, 13359
Italy
GSK Investigational Site
Torrette (AN), Marche, Italy, 60020
GSK Investigational Site
Foggia, Puglia, Italy, 71100
GSK Investigational Site
Cagliari, Sardegna, Italy, 09126
GSK Investigational Site
Pisa, Toscana, Italy, 56124
GSK Investigational Site
Bussolengo (VR), Veneto, Italy, 37012
GSK Investigational Site
Salerno, Italy, 84100
Latvia
GSK Investigational Site
Riga, Latvia, LV 1003
GSK Investigational Site
Riga, Latvia, LV 1035
Netherlands
GSK Investigational Site
Breda, Netherlands, 4819 EV
GSK Investigational Site
Groningen, Netherlands, 9721 SW
GSK Investigational Site
Harderwijk, Netherlands, 3844 DG
GSK Investigational Site
Helmond, Netherlands, 5707 HA
GSK Investigational Site
Hoorn, Netherlands, 1624 NP
GSK Investigational Site
Nieuwegein, Netherlands, 3435 CM
GSK Investigational Site
Veldhoven, Netherlands, 5504 DB
Spain
GSK Investigational Site
Barcelona, Spain, 08022
GSK Investigational Site
Madrid, Spain, 28006
GSK Investigational Site
Tarrasa, Barcelona, Spain, 08221
GSK Investigational Site
Valencia, Spain, 46017
Sweden
GSK Investigational Site
Göteborg, Sweden, SE-413 45
GSK Investigational Site
Linköping, Sweden, SE-585 81
GSK Investigational Site
Lund, Sweden, SE-221 85

Sponsors and Collaborators

GlaxoSmithKline

Investigators

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Study Director:	GSK Clinical Trials, MD	GlaxoSmithKline

More Information

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Responsible Party:	GlaxoSmithKline
ClinicalTrials.gov Identifier:	NCT00291382
Other Study ID Numbers:	SAM49071
First Posted:	February 14, 2006 Key Record Dates
Last Update Posted:	May 30, 2017
Last Verified:	May 2017

Keywords provided by GlaxoSmithKline:


Total asthma control airway hyper-responsiveness adult Asthma

Additional relevant MeSH terms:

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Asthma Bronchial Diseases Respiratory Tract Diseases Lung Diseases, Obstructive Lung Diseases Respiratory Hypersensitivity Hypersensitivity, Immediate Hypersensitivity Immune System Diseases Fluticasone Salmeterol Xinafoate Anti-Inflammatory Agents Bronchodilator Agents	Autonomic Agents Peripheral Nervous System Agents Physiological Effects of Drugs Anti-Asthmatic Agents Respiratory System Agents Dermatologic Agents Anti-Allergic Agents Adrenergic beta-2 Receptor Agonists Adrenergic beta-Agonists Adrenergic Agonists Adrenergic Agents Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action

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