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

Asthma Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00291382
• Other study ID #: SAM49071
• Status: Completed
• Phase: Phase 4
• First received: February 13, 2006
• Last updated: May 24, 2017
• Start date: November 2005
• Est. completion date: July 2007

Study information

• Verified date: May 2017
• Source: GlaxoSmithKline
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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-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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 150
• Est. completion date: July 2007
• Est. primary completion date: July 2007
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Asthma
• Respiratory Hypersensitivity

Intervention

Drug:
• Salmeterol/fluticasone propionate combination

Locations

Country	Name	City	State
Belgium	GSK Investigational Site	Gent
Belgium	GSK Investigational Site	Liège
Estonia	GSK Investigational Site	Tartu
Finland	GSK Investigational Site	Jyvaskyla
Finland	GSK Investigational Site	Tampere
France	GSK Investigational Site	Lille cedex
France	GSK Investigational Site	Montpellier
France	GSK Investigational Site	Poitiers
Germany	GSK Investigational Site	Berlin
Germany	GSK Investigational Site	Berlin
Germany	GSK Investigational Site	Berlin
Germany	GSK Investigational Site	Bonn	Nordrhein-Westfalen
Germany	GSK Investigational Site	Sinsheim	Baden-Wuerttemberg
Italy	GSK Investigational Site	Bussolengo (VR)	Veneto
Italy	GSK Investigational Site	Cagliari	Sardegna
Italy	GSK Investigational Site	Foggia	Puglia
Italy	GSK Investigational Site	Pisa	Toscana
Italy	GSK Investigational Site	Salerno
Italy	GSK Investigational Site	Torrette (AN)	Marche
Latvia	GSK Investigational Site	Riga
Latvia	GSK Investigational Site	Riga
Netherlands	GSK Investigational Site	Breda
Netherlands	GSK Investigational Site	Groningen
Netherlands	GSK Investigational Site	Harderwijk
Netherlands	GSK Investigational Site	Helmond
Netherlands	GSK Investigational Site	Hoorn
Netherlands	GSK Investigational Site	Nieuwegein
Netherlands	GSK Investigational Site	Veldhoven
Spain	GSK Investigational Site	Barcelona
Spain	GSK Investigational Site	Madrid
Spain	GSK Investigational Site	Tarrasa, Barcelona
Spain	GSK Investigational Site	Valencia
Sweden	GSK Investigational Site	Göteborg
Sweden	GSK Investigational Site	Linköping
Sweden	GSK Investigational Site	Lund

Sponsors (1)

Lead Sponsor	Collaborator
GlaxoSmithKline

Countries where clinical trial is conducted

Belgium,  Estonia,  Finland,  France,  Germany,  Italy,  Latvia,  Netherlands,  Spain,  Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Mean change in PC20 methacholine (as a measure of airway hyper-responsiveness) following 24 weeks of treatment.
Secondary	Number of 'Totally-controlled' and Well-controlled patients at the end of the run-in and treatment period according to the GOAL criteria.