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

Primary Purpose

Asthma

Status
Completed
Phase
Phase 4
Locations
International
Study Type
Interventional
Intervention
Salmeterol/fluticasone propionate combination
Sponsored by
GlaxoSmithKline
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Asthma focused on measuring Total asthma control, airway hyper-responsiveness, adult, Asthma

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site

Outcomes

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.

Full Information

First Posted
February 13, 2006
Last Updated
May 24, 2017
Sponsor
GlaxoSmithKline
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1. Study Identification

Unique Protocol Identification Number
NCT00291382
Brief Title
Airway Hyper-responsiveness Study In Asthma Using Salmeterol/Fluticasone Propionate Combination Product
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
Study Type
Interventional

2. Study Status

Record Verification Date
May 2017
Overall Recruitment Status
Completed
Study Start Date
November 2005 (Actual)
Primary Completion Date
July 2007 (Actual)
Study Completion Date
July 2007 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
GlaxoSmithKline

4. Oversight

Data Monitoring Committee
No

5. Study Description

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-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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Asthma
Keywords
Total asthma control, airway hyper-responsiveness, adult, Asthma

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
Double
Allocation
Randomized
Enrollment
150 (Actual)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
Salmeterol/fluticasone propionate combination
Primary Outcome Measure Information:
Title
Mean change in PC20 methacholine (as a measure of airway hyper-responsiveness) following 24 weeks of treatment.
Secondary Outcome Measure Information:
Title
Number of 'Totally-controlled' and Well-controlled patients at the end of the run-in and treatment period according to the GOAL criteria.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
GSK Clinical Trials, MD
Organizational Affiliation
GlaxoSmithKline
Official's Role
Study Director
Facility Information:
Facility Name
GSK Investigational Site
City
Gent
ZIP/Postal Code
9000
Country
Belgium
Facility Name
GSK Investigational Site
City
Liège
ZIP/Postal Code
4000
Country
Belgium
Facility Name
GSK Investigational Site
City
Tartu
ZIP/Postal Code
51014
Country
Estonia
Facility Name
GSK Investigational Site
City
Jyvaskyla
ZIP/Postal Code
40100
Country
Finland
Facility Name
GSK Investigational Site
City
Tampere
ZIP/Postal Code
33100
Country
Finland
Facility Name
GSK Investigational Site
City
Lille cedex
ZIP/Postal Code
59042
Country
France
Facility Name
GSK Investigational Site
City
Montpellier
ZIP/Postal Code
34295
Country
France
Facility Name
GSK Investigational Site
City
Poitiers
ZIP/Postal Code
86000 cedex
Country
France
Facility Name
GSK Investigational Site
City
Sinsheim
State/Province
Baden-Wuerttemberg
ZIP/Postal Code
74889
Country
Germany
Facility Name
GSK Investigational Site
City
Bonn
State/Province
Nordrhein-Westfalen
ZIP/Postal Code
53123
Country
Germany
Facility Name
GSK Investigational Site
City
Berlin
ZIP/Postal Code
10559
Country
Germany
Facility Name
GSK Investigational Site
City
Berlin
ZIP/Postal Code
13353
Country
Germany
Facility Name
GSK Investigational Site
City
Berlin
ZIP/Postal Code
13359
Country
Germany
Facility Name
GSK Investigational Site
City
Torrette (AN)
State/Province
Marche
ZIP/Postal Code
60020
Country
Italy
Facility Name
GSK Investigational Site
City
Foggia
State/Province
Puglia
ZIP/Postal Code
71100
Country
Italy
Facility Name
GSK Investigational Site
City
Cagliari
State/Province
Sardegna
ZIP/Postal Code
09126
Country
Italy
Facility Name
GSK Investigational Site
City
Pisa
State/Province
Toscana
ZIP/Postal Code
56124
Country
Italy
Facility Name
GSK Investigational Site
City
Bussolengo (VR)
State/Province
Veneto
ZIP/Postal Code
37012
Country
Italy
Facility Name
GSK Investigational Site
City
Salerno
ZIP/Postal Code
84100
Country
Italy
Facility Name
GSK Investigational Site
City
Riga
ZIP/Postal Code
LV 1003
Country
Latvia
Facility Name
GSK Investigational Site
City
Riga
ZIP/Postal Code
LV 1035
Country
Latvia
Facility Name
GSK Investigational Site
City
Breda
ZIP/Postal Code
4819 EV
Country
Netherlands
Facility Name
GSK Investigational Site
City
Groningen
ZIP/Postal Code
9721 SW
Country
Netherlands
Facility Name
GSK Investigational Site
City
Harderwijk
ZIP/Postal Code
3844 DG
Country
Netherlands
Facility Name
GSK Investigational Site
City
Helmond
ZIP/Postal Code
5707 HA
Country
Netherlands
Facility Name
GSK Investigational Site
City
Hoorn
ZIP/Postal Code
1624 NP
Country
Netherlands
Facility Name
GSK Investigational Site
City
Nieuwegein
ZIP/Postal Code
3435 CM
Country
Netherlands
Facility Name
GSK Investigational Site
City
Veldhoven
ZIP/Postal Code
5504 DB
Country
Netherlands
Facility Name
GSK Investigational Site
City
Barcelona
ZIP/Postal Code
08022
Country
Spain
Facility Name
GSK Investigational Site
City
Madrid
ZIP/Postal Code
28006
Country
Spain
Facility Name
GSK Investigational Site
City
Tarrasa, Barcelona
ZIP/Postal Code
08221
Country
Spain
Facility Name
GSK Investigational Site
City
Valencia
ZIP/Postal Code
46017
Country
Spain
Facility Name
GSK Investigational Site
City
Göteborg
ZIP/Postal Code
SE-413 45
Country
Sweden
Facility Name
GSK Investigational Site
City
Linköping
ZIP/Postal Code
SE-585 81
Country
Sweden
Facility Name
GSK Investigational Site
City
Lund
ZIP/Postal Code
SE-221 85
Country
Sweden

12. IPD Sharing Statement

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

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