AsthmaPhase 4NCT01324362
GSK BHR Study (Sont - Second Study)
A Phase 4 study testing FP 100mcg, FP 250mcg and FP 500mcg in people with Asthma, run by GlaxoSmithKline at 57 sites in 4 countries.
Trial summary
The purpose of this study was to determine whether asthma control and reduced bronchial responsiveness could be achieved and maintained at a lower dose of inhaled corticosteroids with ADVAIR DISKUS BID or FP BID in adult and adolescent patients with persistent asthma Read more about this study
- Who is it for?
- Ages 12 years and older
- Conditions the study is for
- Asthma
- What is being tested?
- FP 100mcg, FP 250mcg and FP 500mcg
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 446 participants
- Where
- 57 sitesin 4 countries
- Study dates
- Jan 2003to Oct 2004
- 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 12 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Diagnosis of asthma
- Controller asthma medication or medium dose ICS
- Current or historical reversibility
Who cannot join
- Life-threatening asthma
- Asthma instability
- Concurrent respiratory disease
- Drug allergies
- Respiratory tract infection
- Systemic corticosteroid use
Show all 11Show fewer
- Immunosuppressive medication use
- Postive pregnancy test
- Tobacco use
- Investigation medication use
- Site affiliation
Trial locations and contacts
57 sites in 4 countries.
57 sites in 4 countries
United States51 sites
GSK Investigational Site
Aventura, Florida, 33180
GSK Investigational Site
Baltimore, Maryland, 21236
GSK Investigational Site
Bellingham, Washington, 98226
GSK Investigational Site
Birmingham, Alabama, 35294-0012
GSK Investigational Site
Charlotte, North Carolina, 28207
GSK Investigational Site
Chesterfield, Missouri, 63017
GSK Investigational Site
Cincinnati, Ohio, 45231
GSK Investigational Site
Cleveland, Ohio, 44195
GSK Investigational Site
Coeur d'Alene, Idaho, 83814
GSK Investigational Site
Dallas, Texas, 75231-4307
GSK Investigational Site
Dallas, Texas, 75231
GSK Investigational Site
Danville, Virginia, 24541
GSK Investigational Site
Denver, Colorado, 80230
GSK Investigational Site
Des Moines, Iowa, 50309-1426
GSK Investigational Site
Englewood, Colorado, 80112
GSK Investigational Site
Eugene, Oregon, 97401
GSK Investigational Site
Fort Collins, Colorado, 80526
GSK Investigational Site
Friendswood, Texas, 77546
GSK Investigational Site
Glendale, Arizona, 85304
GSK Investigational Site
Houston, Texas, 77030
GSK Investigational Site
Huntington Beach, California, 92647
GSK Investigational Site
Jacksonville, Florida, 32207
GSK Investigational Site
Jasper, Alabama, 35501
GSK Investigational Site
Knoxville, Tennessee, 37922
GSK Investigational Site
Lake Oswego, Oregon, 97035
GSK Investigational Site
Livonia, Michigan, 48152
GSK Investigational Site
Long Beach, California, 90806
GSK Investigational Site
Longwood, Florida, 32750
GSK Investigational Site
Los Angeles, California, 90025
GSK Investigational Site
Los Angeles, California, 90048
GSK Investigational Site
Los Angeles, California, 90095-1752
GSK Investigational Site
Madison, Wisconsin, 53792
GSK Investigational Site
Milwaukee, Wisconsin, 53209-0996
GSK Investigational Site
Mineola, New York, 11501
GSK Investigational Site
North Dartmouth, Massachusetts, 02747
GSK Investigational Site
Oak Brook, Illinois, 60523
GSK Investigational Site
Omaha, Nebraska, 68131
GSK Investigational Site
Omaha, Nebraska, 68198-2456
GSK Investigational Site
Pueblo, Colorado, 81008
GSK Investigational Site
Richmond, Virginia, 23229
GSK Investigational Site
Seattle, Washington, 98105
GSK Investigational Site
South Bend, Indiana, 46617
GSK Investigational Site
Spartanburg, South Carolina, 29303
GSK Investigational Site
Tampa, Florida, 33609
GSK Investigational Site
Tampa, Florida, 33613
GSK Investigational Site
Toledo, Ohio, 43614-5809
GSK Investigational Site
Tucson, Arizona, 85724
GSK Investigational Site
Upland, Pennsylvania, 19013
GSK Investigational Site
Wheat Ridge, Colorado, 80033
GSK Investigational Site
Wilmington, North Carolina, 28401
GSK Investigational Site
Winston-Salem, North Carolina, 27103
Brazil3 sites
GSK Investigational Site
Florianópolis, Santa Catarina, 88040970
GSK Investigational Site
Rio de Janeiro, Rio de Janeiro, 21941-590
GSK Investigational Site
São Paulo, São Paulo
Bulgaria2 sites
GSK Investigational Site
Sofia, 1431/1000
GSK Investigational Site
Varna, 9010
About this study
Official title: A Multicenter, Randomized, Double-blind, Parallel Group, 40-week Comparison of Asthma Control Using Bronchial Hyperresponsiveness as an Additional Guide to Long-term Treatment in Adolescents and Adults Receiving Either Fluticasone Propionate/Sameterol DISKUS Twice Daily or Fluticasone Propionate DISKUS Twice Daily (or Placebo Twice Daily if Asymptomatic)
The purpose of this study was to determine whether asthma control and reduced bronchial responsiveness could be achieved and maintained at a lower dose of inhaled corticosteroids with ADVAIR DISKUS BID or FP BID in adult and adolescent patients with persistent asthma
- Conditions
- Asthma
- Being tested
- Placebo, FP 100mcg, FP 250mcg, FP 500mcg, FSC 100/50mcg
- Keywords
- FP, Asthma, Sont, FSC, BHR
- Medical subject headings
- Asthma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PlaceboDrug
Also called FP 100mcg, FP 250mcg, FP 500mcg
Twice daily dosing
PlaceboDrug
Twice daily dosing
FP 100mcgDrug
Twice daily dosing
FP 250mcgDrug
Twice daily dosing
FP 500mcgDrug
Twice daily dosing
FSC 100/50mcgDrug
Twice daily dosing
FSC 250/50mcgDrug
Twice daily dosing
FSC500/50mcgDrug
Twice daily dosing
| Study group | Role | What they receive |
|---|---|---|
| Fluticasone propionate | Active comparator | Not described Receives: Drug: Placebo; Drug: FP 100mcg; Drug: FP 250mcg; Drug: FP 500mcg |
| Fluticasone propionate/salmeterol combination | Active comparator | Not described Receives: Drug: Placebo; Drug: FSC 100/50mcg; Drug: FSC 250/50mcg; Drug: FSC500/50mcg |
What is being measured
The primary outcome is the main question the study is designed to answer.
Average ICS treatment dose over the treatment period
Measured: Every 8 weeks through 40 weeks of treatment
Secondary outcomes (1)
Pulmonary function measures
Measured: Every 8 weeks through 40 weeks of treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Mar 2011 (estimated)
- Study startJan 2003
- Primary completionOct 2004
- Study completionOct 2004
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- Who is masked
- Participant, Investigator
- Enrolment
- 446 participants (actual)
Sponsor and investigators
- Lead sponsor
- GlaxoSmithKline
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- GSK Clinical Trials, Study director, GlaxoSmithKline
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01324362
- Sponsor's protocol ID
- SAM40065
- Status last verified
- Aug 2016
- First submitted
- 3 Feb 2011
- Last updated
- 1 Sep 2016
- Results posted
- No
- Individual data sharing
- Yes: Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.
Publications
Stauffer JL, Yancey SW, Baitinger LA, Prillaman BA, Dorinsky PM. Measuring airway hyperresponsiveness: Does it add to routine measures of clinical efficacy in guiding asthma therapy? Proc Am Thorac Soc 2006;3:A213
Study at a glance
From the registry record, last updated by the sponsor on 1 Sep 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Randomized, Double-blind, Parallel Group, 40-week Comparison of Asthma Control Using Bronchial Hyperresponsiveness as an Additional Guide to Long-term Treatment in Adolescents and Adults Receiving Either Fluticasone Propionate/Sameterol DISKUS Twice Daily or Fluticasone Propionate DISKUS Twice Daily (or Placebo Twice Daily if Asymptomatic)
- ClinicalTrials.gov ID
- NCT01324362
- Acronym / sponsor ID
- SAM40065
- Conditions
- Asthma
- Keywords
- FP, Asthma, Sont, FSC, BHR
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 446 participants (actual)
- Lead sponsor
- GlaxoSmithKlineIndustry (pharma, biotech, devices)
- Study start
- Jan 2003
- Primary completion
- Oct 2004 (actual)
- Study completion
- Oct 2004 (actual)
- First posted
- 29 Mar 2011 (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.
The purpose of this study was to determine whether asthma control and reduced bronchial responsiveness could be achieved and maintained at a lower dose of inhaled corticosteroids with ADVAIR DISKUS BID or FP BID in adult and adolescent patients with persistent asthma
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Fluticasone propionate | Active comparator | Drug: Placebo, Drug: FP 100mcg, Drug: FP 250mcg, Drug: FP 500mcg |
| Fluticasone propionate/salmeterol combination | Active comparator | Drug: Placebo, Drug: FSC 100/50mcg, Drug: FSC 250/50mcg, Drug: FSC500/50mcg |
Who may qualify
- Ages
- 12 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- Diagnosis of asthma
- Controller asthma medication or medium dose ICS
- Current or historical reversibility
Key exclusion criteria (11 listed)
- Life-threatening asthma
- Asthma instability
- Concurrent respiratory disease
- Drug allergies
- Respiratory tract infection
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 |
|---|---|---|
| PlaceboAlso: FP 100mcg, FP 250mcg, FP 500mcgTwice daily dosing | Drug | Fluticasone propionate |
| PlaceboTwice daily dosing | Drug | Fluticasone propionate/salmeterol combination |
| FP 100mcgTwice daily dosing | Drug | Fluticasone propionate |
| FP 250mcgTwice daily dosing | Drug | Fluticasone propionate |
| FP 500mcgTwice daily dosing | Drug | Fluticasone propionate |
| FSC 100/50mcgTwice daily dosing | Drug | Fluticasone propionate/salmeterol combination |
| FSC 250/50mcgTwice daily dosing | Drug | Fluticasone propionate/salmeterol combination |
| FSC500/50mcgTwice daily dosing | Drug | Fluticasone propionate/salmeterol combination |
Primary outcome
Average ICS treatment dose over the treatment period
Time frame: Every 8 weeks through 40 weeks of treatment
1 secondary outcome
Pulmonary function measures
Time frame: Every 8 weeks through 40 weeks of treatment
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 1 Sep 2016.
- BackgroundStauffer JL, Yancey SW, Baitinger LA, Prillaman BA, Dorinsky PM. Measuring airway hyperresponsiveness: Does it add to routine measures of clinical efficacy in guiding asthma therapy? Proc Am Thorac Soc 2006;3:A213
- Researchers can use this site to request access to anonymised patient level data and/or supporting documents from clinical studies to conduct further research.Link provided by the sponsor.
- Individual participant dataSharing planned: Yes. Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.
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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 study director
GlaxoSmithKline
57 sites in 4 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing FP 100mcg, FP 250mcg and FP 500mcg in people with Asthma, run by GlaxoSmithKline at 57 sites in 4 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 11 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 1 Sep 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 57 sites in United States, Brazil, Bulgaria, Puerto Rico. 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?
Average ICS treatment dose over the treatment period (time frame: Every 8 weeks through 40 weeks of treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01324362, which also lists 1 linked publication.
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 1 Sep 2016; AzTrials last refreshed its copy on 1 Nov 2026.