AsthmaPhase 4NCT00920543
GSK BHR Study (Sont)
A Phase 4 study testing FP 100mcg, FP 500mcg and FP 250mcg in people with Asthma, run by GlaxoSmithKline at 58 sites in 4 countries.
Trial summary
The purpose of this study was to determine whether asthma control and reduced bronchial hyperresponsiveness could be achieved and maintained at a lower dose of inhaled corticosteroids with ADVAIR DISKUS twice-daily or FP twice-daily in adult and adolescent subjects 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 500mcg and FP 250mcg
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 464 participants
- Where
- 58 sitesin 4 countries
- Study dates
- Feb 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
- Asthma diagnosis
- Controller medications or moderate inhaled corticosteroid dose
- Evidence of reversibility
Who cannot join
- Life-threatening asthma
- Asthma instability
- Concurrent respiratory disease
- Drug allergy
- Respiratory tract infection
- Systemic corticosteroid use
Show all 10Show fewer
- Immunosuppressive medication use
- Positive pregnancy test
- Tobacco use
- Site affiliation
Trial locations and contacts
58 sites in 4 countries.
58 sites in 4 countries
United States52 sites
GSK Investigational Site
Absecon, New Jersey, 8201
GSK Investigational Site
Asheville, North Carolina, 28801
GSK Investigational Site
Baltimore, Maryland, 21224
GSK Investigational Site
Bay Pines, Florida, 33744
GSK Investigational Site
Bellingham, Washington, 98226
GSK Investigational Site
Birmingham, Alabama, 35209
GSK Investigational Site
Butte, Montana, 59701
GSK Investigational Site
Canton, Ohio, 44718
GSK Investigational Site
Carmichael, California, 95608
GSK Investigational Site
Charleston, South Carolina, 29407
GSK Investigational Site
Charlottesville, Virginia, 22908
GSK Investigational Site
Cherry Hill, New Jersey, 08003
GSK Investigational Site
Chicago, Illinois, 60637
GSK Investigational Site
Colorado Springs, Colorado, 80907
GSK Investigational Site
Denver, Colorado, 80206
GSK Investigational Site
Gainesville, Florida, 32610
GSK Investigational Site
Hartford, Connecticut, 06106
GSK Investigational Site
Houston, Texas, 77090
GSK Investigational Site
Indianapolis, Indiana, 46208
GSK Investigational Site
Iowa City, Iowa, 52242
GSK Investigational Site
Lafayette, Indiana, 47904
GSK Investigational Site
Lincoln, Rhode Island, 2865
GSK Investigational Site
Louisville, Kentucky, 40215
GSK Investigational Site
Medford, Oregon, 97504
GSK Investigational Site
Minneapolis, Minnesota, 55407
GSK Investigational Site
Morgantown, West Virginia, 26505
GSK Investigational Site
Nashville, Tennessee, 37203-1424
GSK Investigational Site
New Orleans, Louisiana, 70119
GSK Investigational Site
Normal, Illinois, 61761
GSK Investigational Site
Oklahoma City, Oklahoma, 73120
GSK Investigational Site
Palmdale, California, 93551
GSK Investigational Site
Papillion, Nebraska, 68046
GSK Investigational Site
Petoskey, Michigan, 49770
GSK Investigational Site
Phoenix, Arizona, 85006
GSK Investigational Site
Pittsburgh, Pennsylvania, 15213
GSK Investigational Site
Pittsburgh, Pennsylvania, 15241
GSK Investigational Site
Portland, Oregon, 97213
GSK Investigational Site
Rockville Centre, New York, 11570
GSK Investigational Site
San Diego, California, 92103
GSK Investigational Site
San Diego, California, 92120
GSK Investigational Site
San Diego, California, 92123
GSK Investigational Site
San Jose, California, 95117
GSK Investigational Site
San Jose, California, 95128
GSK Investigational Site
Sarasota, Florida, 34233
GSK Investigational Site
Statesville, North Carolina, 28625
GSK Investigational Site
Sylvania, Ohio, 43560
GSK Investigational Site
Tigard, Oregon, 97223
GSK Investigational Site
Toledo, Ohio, 43617
GSK Investigational Site
Trumbull, Connecticut, 06611
GSK Investigational Site
Tucson, Arizona, 85712
GSK Investigational Site
Walnut Creek, California, 94598
GSK Investigational Site
Wheat Ridge, Colorado, 80033
Brazil3 sites
GSK Investigational Site
Porto Alegre, Rio Grande do Sul, 40110-160
GSK Investigational Site
Porto Alegre, Rio Grande do Sul, 90035 003
GSK Investigational Site
Salvador, Estado de Bahia, 41940-060
Latvia2 sites
GSK Investigational Site
Riga, LV 1002
GSK Investigational Site
Riga, LV 1003
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/Salmeterol DISKUS Twice Daily or Fluticasone Propionate DISKUS Twice Daily (or Placebo BID if Asymptomatic)
The purpose of this study was to determine whether asthma control and reduced bronchial hyperresponsiveness could be achieved and maintained at a lower dose of inhaled corticosteroids with ADVAIR DISKUS twice-daily or FP twice-daily in adult and adolescent subjects with persistent asthma
- Conditions
- Asthma
- Being tested
- Placebo, FP 100mcg, FP 500mcg, FP 250mcg, FSC 100/50mcg
- Medical subject headings
- Asthma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PlaceboDrug
Twice daily dosing
FP 100mcgDrug
Twice daily dosing
FP 500mcgDrug
Twice daily dosing
FP 250mcgDrug
Twice daily dosing
FSC 100/50mcgDrug
Twice daily dosing
FSC 250/50mcgDrug
Twice daily dosing
FSC 500/50mcgDrug
Twice daily dosing
| Study group | Role | What they receive |
|---|---|---|
| Fluticasone propionate | Active comparator | Not described Receives: Drug: Placebo; Drug: FP 100mcg; Drug: FP 500mcg; Drug: FP 250mcg |
| Fluticasone propionate/salmeterol combination | Active comparator | Not described Receives: Drug: Placebo; Drug: FSC 100/50mcg; Drug: FSC 250/50mcg; Drug: FSC 500/50mcg |
What is being measured
The primary outcome is the main question the study is designed to answer.
Average inhaled corticosteroid treatment dose over the treatment period
Measured: Every 8 weeks for the 40 week treatment period
Secondary outcomes (1)
Pulmonary function measures
Measured: Every 8 weeks for the 40 week treatment period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jun 2009 (estimated)
- Study startFeb 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 (3)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
- 464 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
- NCT00920543
- Sponsor's protocol ID
- SAM40086
- Status last verified
- Aug 2016
- First submitted
- 12 Jun 2009
- 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
Dorinsky P, Yancey S, Baitinger L, Stauffer J. Measuring Airway Hyperresponsiveness: Does it add to routine measures of clinical efficacy in guiding asthma therapy? Eur Respir J 2006;28(50):319s.
Kerwin EM, Nathan RA, Meltzer EO, Ortega HG, Yancey SW, Schoaf L, Dorinsky PM. Efficacy and safety of fluticasone propionate/salmeterol 250/50 mcg Diskus administered once daily. Respir Med. 2008 Apr;102(4):495-504. doi: 10.1016/j.rmed.2007.12.002. Epub 2008 Feb 21.
PubMed 18206361Koenig SM, Murray JJ, Wolfe J, Andersen L, Yancey S, Prillaman B, Stauffer J, Dorinsky P. Does measuring BHR add to guideline derived clinical measures in determining treatment for patients with persistent asthma? Respir Med. 2008 May;102(5):665-73. doi: 10.1016/j.rmed.2007.12.023. Epub 2008 Mar 6.
PubMed 18328683
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/Salmeterol DISKUS Twice Daily or Fluticasone Propionate DISKUS Twice Daily (or Placebo BID if Asymptomatic)
- ClinicalTrials.gov ID
- NCT00920543
- Acronym / sponsor ID
- SAM40086
- Conditions
- Asthma
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 464 participants (actual)
- Lead sponsor
- GlaxoSmithKlineIndustry (pharma, biotech, devices)
- Study start
- Feb 2003
- Primary completion
- Oct 2004 (actual)
- Study completion
- Oct 2004 (actual)
- First posted
- 15 Jun 2009 (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 hyperresponsiveness could be achieved and maintained at a lower dose of inhaled corticosteroids with ADVAIR DISKUS twice-daily or FP twice-daily in adult and adolescent subjects 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 500mcg, Drug: FP 250mcg |
| Fluticasone propionate/salmeterol combination | Active comparator | Drug: Placebo, Drug: FSC 100/50mcg, Drug: FSC 250/50mcg, Drug: FSC 500/50mcg |
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)
- Asthma diagnosis
- Controller medications or moderate inhaled corticosteroid dose
- Evidence of reversibility
Key exclusion criteria (10 listed)
- Life-threatening asthma
- Asthma instability
- Concurrent respiratory disease
- Drug allergy
- 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 |
|---|---|---|
| PlaceboTwice daily dosing | Drug | Fluticasone propionate, Fluticasone propionate/salmeterol combination |
| FP 100mcgTwice daily dosing | Drug | Fluticasone propionate |
| FP 500mcgTwice daily dosing | Drug | Fluticasone propionate |
| FP 250mcgTwice 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 |
| FSC 500/50mcgTwice daily dosing | Drug | Fluticasone propionate/salmeterol combination |
Primary outcome
Average inhaled corticosteroid treatment dose over the treatment period
Time frame: Every 8 weeks for the 40 week treatment period
1 secondary outcome
Pulmonary function measures
Time frame: Every 8 weeks for the 40 week treatment period
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.
- BackgroundDorinsky P, Yancey S, Baitinger L, Stauffer J. Measuring Airway Hyperresponsiveness: Does it add to routine measures of clinical efficacy in guiding asthma therapy? Eur Respir J 2006;28(50):319s.
- Background: PubMed 18206361Kerwin EM, Nathan RA, Meltzer EO, Ortega HG, Yancey SW, Schoaf L, Dorinsky PM. Efficacy and safety of fluticasone propionate/salmeterol 250/50 mcg Diskus administered once daily. Respir Med. 2008 Apr;102(4):495-504. doi: 10.1016/j.rmed.2007.12.002. Epub 2008 Feb 21.
- Background: PubMed 18328683Koenig SM, Murray JJ, Wolfe J, Andersen L, Yancey S, Prillaman B, Stauffer J, Dorinsky P. Does measuring BHR add to guideline derived clinical measures in determining treatment for patients with persistent asthma? Respir Med. 2008 May;102(5):665-73. doi: 10.1016/j.rmed.2007.12.023. Epub 2008 Mar 6.
- 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
58 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 500mcg and FP 250mcg in people with Asthma, run by GlaxoSmithKline at 58 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 10 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 58 sites in United States, Brazil, Latvia, 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 inhaled corticosteroid treatment dose over the treatment period (time frame: Every 8 weeks for the 40 week treatment period). 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 NCT00920543, which also lists 3 linked publications.
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.