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

Study Description

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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

Arms and Interventions

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Outcome Measures

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Primary Outcome Measures :

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

Secondary Outcome Measures :

1. 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

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Ages Eligible for Study:	18 Years and older (Adult, Senior)
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

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  Show 35 Study Locations

Sponsors and Collaborators

GlaxoSmithKline

Investigators

Study Director:	GSK Clinical Trials, MD	GlaxoSmithKline

More Information

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Responsible Party:	GlaxoSmithKline
ClinicalTrials.gov Identifier:	NCT00291382 History of Changes
Other Study ID Numbers:	SAM49071
First Posted:	February 14, 2006
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:

Asthma; Respiratory Hypersensitivity; Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases; 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