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

This study has been completed.
Information provided by:
GlaxoSmithKline Identifier:
First received: February 13, 2006
Last updated: March 17, 2011
Last verified: March 2011
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
Drug: Salmeterol/fluticasone propionate combination
Phase 4

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

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.

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.

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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.
  Contacts and Locations
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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: Cheri Hudson; Clinical Disclosure Advisor, GSK Clinical Disclosure Identifier: NCT00291382     History of Changes
Other Study ID Numbers: SAM49071 
Study First Received: February 13, 2006
Last Updated: March 17, 2011
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

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

Additional relevant MeSH terms:
Respiratory Hypersensitivity
Bronchial Diseases
Hypersensitivity, Immediate
Immune System Diseases
Lung Diseases
Lung Diseases, Obstructive
Respiratory Tract Diseases
Salmeterol Xinafoate
Adrenergic Agents
Adrenergic Agonists
Adrenergic beta-2 Receptor Agonists
Adrenergic beta-Agonists
Anti-Allergic Agents
Anti-Asthmatic Agents
Anti-Inflammatory Agents
Autonomic Agents
Bronchodilator Agents
Dermatologic Agents
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Respiratory System Agents processed this record on May 24, 2016