AsthmaPhase 4NCT00102765

Study Of Asthma In Patients Of African Descent

A Phase 4 study testing fluticasone propionate/salmeterol powder and fluticasone propionate powder in people with Asthma, run by GlaxoSmithKline at 75 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 12 to 65 years
Conditions the study is for: Asthma
What is being tested?: fluticasone propionate/salmeterol powder and fluticasone propionate powder
How many people: 479 participants
Where: 75 sitesUnited States
Study dates: Nov 2004to Apr 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 12 to 65 years
All sexes
No healthy volunteers
Child, Adult, Older adult

Who may be able to join

History of asthma for at least 6 months.
Taking a low-dose of an inhaled corticosteroid for at least one month prior to the study (such as fluticasone propionate or budesonide).

Who cannot join

History of life-threatening asthma.
Hospitalized for asthma within 3 months prior to the study.
Current respiratory tract infection.
Will not be able to attend clinic visits for the entire length of the study.
Certain medical conditions that will make being in the study unsafe (such as congestive heart failure, uncontrolled hypertension, tuberculosis or certain drug allergies).

Trial locations and contacts

75 sites in 1 country.

City, postcode or hospital

75 sites in 1 country

United States75 sites

GSK Investigational Site
Atlanta, Georgia, 30342
GSK Investigational Site
Austin, Texas, 78750
GSK Investigational Site
Baltimore, Maryland, 21236
GSK Investigational Site
Bethesda, Maryland, 20814
GSK Investigational Site
Birmingham, Alabama, 35205
GSK Investigational Site
Birmingham, Alabama, 35209
GSK Investigational Site
Birmingham, Alabama, 35294-0012
GSK Investigational Site
Boston, Massachusetts, 02114
GSK Investigational Site
Brooklyn, New York, 11215
GSK Investigational Site
Chapel Hill, North Carolina, 27599
GSK Investigational Site
Charleston, South Carolina, 29406-7108
GSK Investigational Site
Charleston, South Carolina, 29407
GSK Investigational Site
Charlotte, North Carolina, 28204
GSK Investigational Site
Chattanooga, Tennessee, 37421
GSK Investigational Site
Chicago, Illinois, 60637
GSK Investigational Site
Cincinnati, Ohio, 45231
GSK Investigational Site
Cleveland, Ohio, 44106
GSK Investigational Site
Columbus, Georgia, 31904
GSK Investigational Site
Dallas, Texas, 75230
GSK Investigational Site
Dallas, Texas, 75246
GSK Investigational Site
Decatur, Georgia, 30030
GSK Investigational Site
Detroit, Michigan, 48201
GSK Investigational Site
Durham, North Carolina, 27710
GSK Investigational Site
Elizabeth City, North Carolina, 27909
GSK Investigational Site
Flossmoor, Illinois, 60422
GSK Investigational Site
Greenville, South Carolina, 29607
GSK Investigational Site
Hartford, Connecticut, 06105
GSK Investigational Site
High Point, North Carolina, 27262
GSK Investigational Site
Houston, Texas, 77054
GSK Investigational Site
Jackson, Mississippi, 39202
GSK Investigational Site
Jacksonville, Florida, 32205
GSK Investigational Site
Jenkintown, Pennsylvania, 19406
GSK Investigational Site
Knoxville, Tennessee, 37909
GSK Investigational Site
Knoxville, Tennessee, 37920
GSK Investigational Site
Lafayette, Louisiana, 70503
GSK Investigational Site
Little Rock, Arkansas, 72204
GSK Investigational Site
Little Rock, Arkansas, 72205
GSK Investigational Site
Long Beach, California, 90806
GSK Investigational Site
Los Angeles, California, 90048
GSK Investigational Site
Madison, Wisconsin, 53792
GSK Investigational Site
Martinez, Georgia, 30907
GSK Investigational Site
Metairie, Louisiana, 70006
GSK Investigational Site
Minneapolis, Minnesota, 55455
GSK Investigational Site
Mobile, Alabama, 36608
GSK Investigational Site
Montgomery, Alabama, 36106
GSK Investigational Site
Muscle Shoals, Alabama, 35662
GSK Investigational Site
Nashville, Tennessee, 37203-1424
GSK Investigational Site
Nashville, Tennessee, 37208
GSK Investigational Site
New York, New York, 10032
GSK Investigational Site
Newport News, Virginia, 23601
GSK Investigational Site
Norfolk, Virginia, 23507
GSK Investigational Site
Oklahoma City, Oklahoma, 73120
GSK Investigational Site
Orangeburg, South Carolina, 29118
GSK Investigational Site
Palmdale, California, 93551
GSK Investigational Site
Philadelphia, Pennsylvania, 19102
GSK Investigational Site
Philadelphia, Pennsylvania, 19104-6160
GSK Investigational Site
Philadelphia, Pennsylvania, 19107
GSK Investigational Site
Picayune, Mississippi, 39466
GSK Investigational Site
Richmond, Virginia, 23225
GSK Investigational Site
Richmond, Virginia, 23229
GSK Investigational Site
Riverside, California, 92506
GSK Investigational Site
San Francisco, California, 94102
GSK Investigational Site
Savannah, Georgia, 31406
GSK Investigational Site
St Louis, Missouri, 63110
GSK Investigational Site
Stockton, California, 95207
GSK Investigational Site
Sunset, Louisiana, 70584
GSK Investigational Site
Sylvania, Ohio, 43560
GSK Investigational Site
Tallahassee, Florida, 32308
GSK Investigational Site
Verona, New Jersey, 07044
GSK Investigational Site
Walnut Creek, California, 94598
GSK Investigational Site
Washington D.C., District of Columbia, 20010
GSK Investigational Site
Washington D.C., District of Columbia, 20060
GSK Investigational Site
West Sayville, New York, 11796
GSK Investigational Site
Winston-Salem, North Carolina, 27103
GSK Investigational Site
Ypsilanti, Michigan, 48197

Other trials in United States

About this study

Official title: A Multicenter, Randomized, Double-Blind, Parallel Group, 52-Week Comparison of Asthma Control and Measures of Airway Inflammation in Subjects of African Descent Receiving Fluticasone Propionate/Salmeterol 100/50mcg DISKUS® BID or Fluticasone Propionate 100mcg DISKUS® BID Alone

This study will last up to 62 weeks. You will visit the clinic up to 17 times. Certain clinic visits will include physical examination, medical history review and lung function tests. The purpose of this study is to see if one asthma drug (fluticasone propionate/salmeterol) is better in reducing the number of asthma exacerbations compared with another drug (fluticasone propionate alone)

Conditions: Asthma
Being tested: fluticasone propionate/salmeterol powder, fluticasone propionate powder
Keywords: asthma exacerbation, asthma
Medical subject headings: Asthma

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

fluticasone propionate/salmeterol powderDrug
fluticasone propionate powderDrug
Also called fluticasone propionate/salmeterol powder

What is being measured

The primary outcome is the main question the study is designed to answer.

Asthma exacerbation rate per patient per year

Secondary outcomes (1)

Morning peak flow measurement, percent of asthma symptom-free days, percent of albuterol-free days

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Nov 2004Apr 2007

First posted2 Feb 2005 (estimated)
Study startNov 2004
Primary completionApr 2007
Study completionApr 2007

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
Enrolment: 479 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00102765
Sponsor's protocol ID: SFA103153
Status last verified: Jan 2017
First submitted: 1 Feb 2005
Last updated: 18 Jan 2017
Results posted: No
Data monitoring committee: 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

Bailey W, Castro M, Matz J, White M, Dransfield M, Yancey S, Ortega H. Asthma exacerbations in African Americans treated for 1 year with combination fluticasone propionate and salmeterol or fluticasone propionate alone. Curr Med Res Opin. 2008 Jun;24(6):1669-82. doi: 10.1185/03007990802119111. Epub 2008 May 6.
PubMed 18462564
Anderson WH, Koshy BT, Huang L, Mosteller M, Stinnett SW, Condreay LD, Ortega H. Genetic analysis of asthma exacerbations. Ann Allergy Asthma Immunol. 2013 Jun;110(6):416-422.e2. doi: 10.1016/j.anai.2013.04.002.
PubMed 23706709
Camargo CA Jr, Sutherland ER, Bailey W, Castro M, Yancey SW, Emmett AH, Stempel DA. Effect of increased body mass index on asthma risk, impairment and response to asthma controller therapy in African Americans. Curr Med Res Opin. 2010 Jul;26(7):1629-35. doi: 10.1185/03007995.2010.483113.
PubMed 20429821

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

RecruitingPhase 1
Pilot Study to Identify the Mediators and Inflammatory Cell Surface Receptors Involved in Allergic Airway Inflammation
Asthma
RecruitingPhase 1
A Study to Compare the Relative Potency of Salbutamol Administered Via Metered Dose Inhalers (MDI) Containing Propellants HFA-152a to HFA-134a in Mild Asthmatics Aged 18 to 65 Inclusive
Asthma, Mild Asthma
RecruitingPhase 3
A Study Assessing the Effect of Dupilumab on Inducing Clinical Remission in Asthma
Asthma Control
Active, not recruitingPhase 2/3
Local Antibiotic Delivery for Community Acquired Pneumonia
Community Acquired Pneumonia (CAP)
RecruitingPhase 2
A Study to Learn About the Study Medicine Called PF-07275315 in People With Moderate-To-Severe Asthma
Asthma

All Asthma trials

Study at a glance

From the registry record, last updated by the sponsor on 18 Jan 2017. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Multicenter, Randomized, Double-Blind, Parallel Group, 52-Week Comparison of Asthma Control and Measures of Airway Inflammation in Subjects of African Descent Receiving Fluticasone Propionate/Salmeterol 100/50mcg DISKUS® BID or Fluticasone Propionate 100mcg DISKUS® BID Alone
ClinicalTrials.gov ID: NCT00102765
Acronym / sponsor ID: SFA103153
Conditions: Asthma
Keywords: asthma exacerbation, asthma
Phase: Phase 4
Study type: Interventional
Recruitment status: Completed
Enrolment: 479 participants (actual)
Lead sponsor: GlaxoSmithKlineIndustry (pharma, biotech, devices)
Study start: Nov 2004
Primary completion: Apr 2007 (actual)
Study completion: Apr 2007 (actual)
First posted: 2 Feb 2005 (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.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind

Who may qualify

Ages: 12 to 65 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Child, Adult, Older adult

Key inclusion criteria (2 listed)

History of asthma for at least 6 months.
Taking a low-dose of an inhaled corticosteroid for at least one month prior to the study (such as fluticasone propionate or budesonide).

Key exclusion criteria (5 listed)

History of life-threatening asthma.
Hospitalized for asthma within 3 months prior to the study.
Current respiratory tract infection.
Will not be able to attend clinic visits for the entire length of the study.
Certain medical conditions that will make being in the study unsafe (such as congestive heart failure, uncontrolled hypertension, tuberculosis or certain drug allergies).

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
fluticasone propionate/salmeterol powder	Drug	–
fluticasone propionate powderAlso: fluticasone propionate/salmeterol powder	Drug	–

Primary outcome

Asthma exacerbation rate per patient per year

1 secondary outcome

Morning peak flow measurement, percent of asthma symptom-free days, percent of albuterol-free days

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 18 Jan 2017.
Background: PubMed 18462564Bailey W, Castro M, Matz J, White M, Dransfield M, Yancey S, Ortega H. Asthma exacerbations in African Americans treated for 1 year with combination fluticasone propionate and salmeterol or fluticasone propionate alone. Curr Med Res Opin. 2008 Jun;24(6):1669-82. doi: 10.1185/03007990802119111. Epub 2008 May 6.
Derived from this study: PubMed 23706709Anderson WH, Koshy BT, Huang L, Mosteller M, Stinnett SW, Condreay LD, Ortega H. Genetic analysis of asthma exacerbations. Ann Allergy Asthma Immunol. 2013 Jun;110(6):416-422.e2. doi: 10.1016/j.anai.2013.04.002.
Derived from this study: PubMed 20429821Camargo CA Jr, Sutherland ER, Bailey W, Castro M, Yancey SW, Emmett AH, Stempel DA. Effect of increased body mass index on asthma risk, impairment and response to asthma controller therapy in African Americans. Curr Med Res Opin. 2010 Jul;26(7):1629-35. doi: 10.1185/03007995.2010.483113.
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.

Related trials for Asthma

RecruitingPhase 1
Pilot Study to Identify the Mediators and Inflammatory Cell Surface Receptors Involved in Allergic Airway Inflammation
Asthma
RecruitingPhase 1
A Study to Compare the Relative Potency of Salbutamol Administered Via Metered Dose Inhalers (MDI) Containing Propellants HFA-152a to HFA-134a in Mild Asthmatics Aged 18 to 65 Inclusive
Asthma, Mild Asthma
RecruitingPhase 3
A Study Assessing the Effect of Dupilumab on Inducing Clinical Remission in Asthma
Asthma Control
Active, not recruitingPhase 2/3
Local Antibiotic Delivery for Community Acquired Pneumonia
Community Acquired Pneumonia (CAP)
RecruitingPhase 2
A Study to Learn About the Study Medicine Called PF-07275315 in People With Moderate-To-Severe Asthma
Asthma

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

75 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing fluticasone propionate/salmeterol powder and fluticasone propionate powder in people with Asthma, run by GlaxoSmithKline at 75 sites in United States.

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 2 inclusion and 5 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 18 Jan 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 75 sites in United States. 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?

Asthma exacerbation rate per patient per year. 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 NCT00102765, 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 18 Jan 2017.