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Airway Hyper-Responsiveness Study In Asthma Using Salmeterol/Fluticasone Propionate Combination Product
This study has been completed.
Study NCT00291382   Information provided by GlaxoSmithKline
First Received: February 13, 2006   Last Updated: November 13, 2008   History of Changes
This Tabular View shows the required WHO registration data elements as marked by

February 13, 2006
November 13, 2008
November 2005
Mean change in PC20 methacholine (as a measure of airway hyper-responsiveness) following 24 weeks of treatment.
Same as current
Complete list of historical versions of study NCT00291382 on ClinicalTrials.gov Archive Site
Number of 'Totally-controlled' and Well-controlled patients at the end of the run-in and treatment period according to the GOAL criteria.
Same as current
 
Airway Hyper-Responsiveness Study In Asthma Using Salmeterol/Fluticasone Propionate Combination Product
See Detailed Description

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.

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.

Phase IV
Interventional
Treatment, Randomized, Double-Blind, Parallel Assignment, Efficacy Study
Asthma
Drug: Salmeterol/fluticasone propionate combination
 
 

*   Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
 
Completed
150
 
 

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.
Both
18 Years and older
No
 
Belgium,   Estonia,   Finland,   France,   Germany,   Italy,   Latvia,   Netherlands,   Spain,   Sweden
 
 
NCT00291382
Study Director, GSK
 
GlaxoSmithKline
 
Study Director: GSK Clinical Trials, MD GlaxoSmithKline
GlaxoSmithKline
November 2008

 †    Required WHO trial registration data element.
††   WHO trial registration data element that is required only if it exists.