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

May 24, 2017 updated by: GlaxoSmithKline

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

150

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Belgium
      • Gent, Belgium, 9000
        • GSK Investigational Site
      • Liège, Belgium, 4000
        • GSK Investigational Site
  • Estonia
      • Tartu, Estonia, 51014
        • GSK Investigational Site
  • Finland
      • Jyvaskyla, Finland, 40100
        • GSK Investigational Site
      • Tampere, Finland, 33100
        • GSK Investigational Site
  • France
      • Lille cedex, France, 59042
        • GSK Investigational Site
      • Montpellier, France, 34295
        • GSK Investigational Site
      • Poitiers, France, 86000 cedex
        • GSK Investigational Site
  • Germany
      • Berlin, Germany, 13353
        • GSK Investigational Site
      • Berlin, Germany, 10559
        • GSK Investigational Site
      • Berlin, Germany, 13359
        • GSK Investigational Site
    • Baden-Wuerttemberg
      • Sinsheim, Baden-Wuerttemberg, Germany, 74889
        • GSK Investigational Site
    • Nordrhein-Westfalen
      • Bonn, Nordrhein-Westfalen, Germany, 53123
        • GSK Investigational Site
  • Italy
      • Salerno, Italy, 84100
        • GSK Investigational Site
    • Marche
      • Torrette (AN), Marche, Italy, 60020
        • GSK Investigational Site
    • Puglia
      • Foggia, Puglia, Italy, 71100
        • GSK Investigational Site
    • Sardegna
      • Cagliari, Sardegna, Italy, 09126
        • GSK Investigational Site
    • Toscana
      • Pisa, Toscana, Italy, 56124
        • GSK Investigational Site
    • Veneto
      • Bussolengo (VR), Veneto, Italy, 37012
        • GSK Investigational Site
  • Latvia
      • Riga, Latvia, LV 1035
        • GSK Investigational Site
      • Riga, Latvia, LV 1003
        • GSK Investigational Site
  • Netherlands
      • 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
        • GSK Investigational Site
  • Spain
      • Barcelona, Spain, 08022
        • GSK Investigational Site
      • Madrid, Spain, 28006
        • GSK Investigational Site
      • Tarrasa, Barcelona, Spain, 08221
        • GSK Investigational Site
      • Valencia, Spain, 46017
        • GSK Investigational Site
  • Sweden
      • Göteborg, Sweden, SE-413 45
        • GSK Investigational Site
      • Linköping, Sweden, SE-585 81
        • GSK Investigational Site
      • Lund, Sweden, SE-221 85
        • GSK Investigational Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

GlaxoSmithKline

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 1, 2005

Primary Completion (Actual)

July 1, 2007

Study Completion (Actual)

July 1, 2007

Study Registration Dates

First Submitted

February 13, 2006

First Submitted That Met QC Criteria

February 13, 2006

First Posted (Estimate)

February 14, 2006

Study Record Updates

Last Update Posted (Actual)

May 30, 2017

Last Update Submitted That Met QC Criteria

May 24, 2017

Last Verified

May 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SAM49071

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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