Last updated: 11/04/2018 11:15:59
Airway Hyper-responsiveness Study In Asthma Using Salmeterol/Fluticasone Propionate Combination Product
Clinicaltrials.gov ID
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Study complete
Study complete
Trial overview
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
Trial 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.
Primary purpose:
Treatment
Trial design:
Parallel Assignment
Masking:
Not applicable
Allocation:
Randomized
Primary outcomes:
Not applicable
Secondary outcomes:
Not applicable
Interventions:
Enrollment:
150
Primary completion date:
Not applicable
Observational study model:
Not applicable
Time perspective:
Not applicable
Clinical publications:
Not applicable
Medical condition
Asthma
Product
fluticasone propionate, salmeterol
Collaborators
Not applicable
Study date(s)
November 2005 to July 2007
Type
Interventional
Phase
4
Participation criteria
Sex
Female & Male
Age
18+ years
Accepts healthy volunteers
No
- 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 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.
Inclusion and exclusion 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.
Trial location(s)
Location
GSK Investigational Site
Sinsheim, Baden-Wuerttemberg, Germany, 74889
Status
Study Complete
Location
GSK Investigational Site
Bonn, Nordrhein-Westfalen, Germany, 53123
Status
Study Complete
Study documents
Scientific result summary
Available language(s): English
If you wish to request for full study report, please contact - [email protected]
Results overview
Refer to study documents
Recruitment status
Study complete
Actual primary completion date
Not applicable
Actual study completion date
2007-06-07
Plain language summaries
Plain language summaries of clinical trial results for Phase 2-4 clinical trials that were initiated on or after January 2022 will be posted by GSK within one year following study completion.
Additional information about the trial
Additional information
Not applicable
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