AsthmaPhase 4NCT00291382
Airway Hyper-responsiveness Study In Asthma Using Salmeterol/Fluticasone Propionate Combination Product
A Phase 4 study testing Salmeterol/fluticasone propionate combination in people with Asthma, run by GlaxoSmithKline at 35 sites in 10 countries.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Asthma
- What is being tested?
- Salmeterol/fluticasone propionate combination
- How many people
- 150 participants
- Where
- 35 sitesin 10 countries
- Study dates
- Nov 2005to Jul 2007
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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 locations and contacts
35 sites in 10 countries.
35 sites in 10 countries
Netherlands7 sites
GSK Investigational Site
Breda, 4819 EV
GSK Investigational Site
Groningen, 9721 SW
GSK Investigational Site
Harderwijk, 3844 DG
GSK Investigational Site
Helmond, 5707 HA
GSK Investigational Site
Hoorn, 1624 NP
GSK Investigational Site
Nieuwegein, 3435 CM
GSK Investigational Site
Veldhoven, 5504 DB
Italy6 sites
GSK Investigational Site
Bussolengo (VR), Veneto, 37012
GSK Investigational Site
Cagliari, Sardinia, 09126
GSK Investigational Site
Foggia, Apulia, 71100
GSK Investigational Site
Pisa, Tuscany, 56124
GSK Investigational Site
Salerno, 84100
GSK Investigational Site
Torrette (AN), The Marches, 60020
Germany5 sites
GSK Investigational Site
Berlin, 10559
GSK Investigational Site
Berlin, 13353
GSK Investigational Site
Berlin, 13359
GSK Investigational Site
Bonn, North Rhine-Westphalia, 53123
GSK Investigational Site
Sinsheim, Baden-Wurttemberg, 74889
Spain4 sites
GSK Investigational Site
Barcelona, 08022
GSK Investigational Site
Madrid, 28006
GSK Investigational Site
Tarrasa, Barcelona, 08221
GSK Investigational Site
Valencia, 46017
France3 sites
GSK Investigational Site
Lille, 59042
GSK Investigational Site
Montpellier, 34295
GSK Investigational Site
Poitiers, 86000 cedex
Sweden3 sites
GSK Investigational Site
Gothenburg, SE-413 45
GSK Investigational Site
Linköping, SE-585 81
GSK Investigational Site
Lund, SE-221 85
Belgium2 sites
GSK Investigational Site
Ghent, 9000
GSK Investigational Site
Liège, 4000
Finland2 sites
GSK Investigational Site
Jyväskylä, 40100
GSK Investigational Site
Tampere, 33100
Latvia2 sites
GSK Investigational Site
Riga, LV 1003
GSK Investigational Site
Riga, LV 1035
About this study
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
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.
Read the 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.
- Conditions
- Asthma
- Being tested
- Salmeterol/fluticasone propionate combination
- Keywords
- Total asthma control, airway hyper-responsiveness, adult, Asthma
- Medical subject headings
- Asthma, Respiratory Hypersensitivity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Salmeterol/fluticasone propionate combinationDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean change in PC20 methacholine (as a measure of airway hyper-responsiveness) following 24 weeks of treatment.
Secondary outcomes (1)
Number of 'Totally-controlled' and Well-controlled patients at the end of the run-in and treatment period according to the GOAL criteria.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Feb 2006 (estimated)
- Study startNov 2005
- Primary completionJul 2007
- Study completionJul 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AsthmaStudies of the same condition, open and under way.
- More trials run by GlaxoSmithKlineThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Enrolment
- 150 participants (actual)
Sponsor and investigators
- Lead sponsor
- GlaxoSmithKline
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- GSK Clinical Trials, MD, Study director, GlaxoSmithKline
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00291382
- Sponsor's protocol ID
- SAM49071
- Status last verified
- May 2017
- First submitted
- 13 Feb 2006
- Last updated
- 30 May 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 May 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT00291382
- Acronym / sponsor ID
- SAM49071
- Conditions
- Asthma
- Keywords
- Total asthma control, airway hyper-responsiveness, adult, Asthma
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 150 participants (actual)
- Lead sponsor
- GlaxoSmithKlineIndustry (pharma, biotech, devices)
- Study start
- Nov 2005 (actual)
- Primary completion
- Jul 2007 (actual)
- Study completion
- Jul 2007 (actual)
- First posted
- 14 Feb 2006 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (6 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Salmeterol/fluticasone propionate combination | Drug | – |
Primary outcome
Mean change in PC20 methacholine (as a measure of airway hyper-responsiveness) following 24 weeks of treatment.
1 secondary outcome
Number of 'Totally-controlled' and Well-controlled patients at the end of the run-in and treatment period according to the GOAL criteria.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 May 2017.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
GSK Clinical Trials, MD study director
GlaxoSmithKline
35 sites in 10 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Salmeterol/fluticasone propionate combination in people with Asthma, run by GlaxoSmithKline at 35 sites in 10 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 May 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 35 sites in Netherlands, Italy, Germany, Spain, France and 5 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mean change in PC20 methacholine (as a measure of airway hyper-responsiveness) following 24 weeks of treatment.. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 May 2017.