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Status:

COMPLETED

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

Lead Sponsor:

GlaxoSmithKline

Conditions:

Asthma

Eligibility:

All Genders

18+ years

Phase:

PHASE4

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...

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-responsivenes...

Eligibility Criteria

Inclusion

  • 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.

Exclusion

    Key Trial Info

    Start Date :

    November 1 2005

    Trial Type :

    INTERVENTIONAL

    Allocation :

    ACTUAL

    End Date :

    July 1 2007

    Estimated Enrollment :

    150 Patients enrolled

    Trial Details

    Trial ID

    NCT00291382

    Start Date

    November 1 2005

    End Date

    July 1 2007

    Last Update

    May 30 2017

    Active Locations (35)

    Enter a location and click search to find clinical trials sorted by distance.

    Page 1 of 9 (35 locations)

    1

    GSK Investigational Site

    Ghent, Belgium, 9000

    2

    GSK Investigational Site

    Liège, Belgium, 4000

    3

    GSK Investigational Site

    Tartu, Estonia, 51014

    4

    GSK Investigational Site

    Jyväskylä, Finland, 40100