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

This study has been completed.
Information provided by (Responsible Party):
GlaxoSmithKline Identifier:
First received: February 13, 2006
Last updated: May 24, 2017
Last verified: May 2017
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 4

Study Type: Interventional
Study Design: 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

Resource links provided by NLM:

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.

Enrollment: 150
Actual Study Start Date: November 2005
Study Completion Date: July 2007
Primary Completion Date: July 2007 (Final data collection date for primary outcome measure)
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.

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.
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Please refer to this study by its identifier: NCT00291382

  Show 35 Study Locations
Sponsors and Collaborators
Study Director: GSK Clinical Trials, MD GlaxoSmithKline
  More Information

Responsible Party: GlaxoSmithKline Identifier: NCT00291382     History of Changes
Other Study ID Numbers: SAM49071
Study First Received: February 13, 2006
Last Updated: May 24, 2017

Keywords provided by GlaxoSmithKline:
Total asthma control
airway hyper-responsiveness

Additional relevant MeSH terms:
Respiratory Hypersensitivity
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Hypersensitivity, Immediate
Immune System Diseases
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 processed this record on August 23, 2017