AsthmaPhase 4NCT00102882

Study Of Asthma And Genetics In Patients To Be Treated With Fluticasone Propionate/Salmeterol Or Salmeterol Xinafoate

A Phase 4 study testing fluticasone propionate/salmeterol and salmeterol xinafoate in people with Asthma, run by GlaxoSmithKline at 91 sites in 4 countries.

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 years and older
Conditions the study is for: Asthma
What is being tested?: fluticasone propionate/salmeterol and salmeterol xinafoate
How many people: 547 participants
Where: 91 sitesin 4 countries
Study dates: Oct 2004to Jan 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 years and older
All sexes
No healthy volunteers
Child, Adult, Older adult

Who may be able to join

Diagnosis of persistent asthma for 3 months.
Use of short-acting beta-agonist medication like VENTOLIN.

Who cannot join

Hospitalization for asthma 6 months before study.
Other serious diseases like congestive heart failure, uncontrolled hypertension, TB.
Current use of inhaled or oral corticosteroids.

Trial locations and contacts

91 sites in 4 countries.

Country

City, postcode or hospital

91 sites in 4 countries

United States86 sites

GSK Investigational Site
Asheville, North Carolina, 28801
GSK Investigational Site
Atlanta, Georgia, 30310
GSK Investigational Site
Baltimore, Maryland, 21201
GSK Investigational Site
Baltimore, Maryland, 21237
GSK Investigational Site
Bay Shore, New York, 11706
GSK Investigational Site
Bellingham, Washington, 98225
GSK Investigational Site
Boston, Massachusetts, 02118
GSK Investigational Site
Charleston, South Carolina, 29407
GSK Investigational Site
Charleston, South Carolina, 29414
GSK Investigational Site
Chattanooga, Tennessee, 37421
GSK Investigational Site
Chicago, Illinois, 60612
GSK Investigational Site
Chicago, Illinois, 60637
GSK Investigational Site
Colorado Springs, Colorado, 80907
GSK Investigational Site
Columbia, Missouri, 65203
GSK Investigational Site
Coral Gables, Florida, 33134
GSK Investigational Site
Corsicana, Texas, 75110
GSK Investigational Site
Covington, Louisiana, 70433
GSK Investigational Site
Dallas, Texas, 75230
GSK Investigational Site
Dallas, Texas, 75246
GSK Investigational Site
Denver, Colorado, 80206
GSK Investigational Site
Denver, Colorado, 80209
GSK Investigational Site
El Paso, Texas, 79902
GSK Investigational Site
El Paso, Texas, 79925
GSK Investigational Site
Fort Worth, Texas, 76104
GSK Investigational Site
Fresno, California, 93720
GSK Investigational Site
Fullerton, California, 92835
GSK Investigational Site
Hackensack, New Jersey, 07601
GSK Investigational Site
Houston, Texas, 77054
GSK Investigational Site
Huntington Beach, California, 92647
GSK Investigational Site
Indianapolis, Indiana, 46208
GSK Investigational Site
Inglewood, California, 90301
GSK Investigational Site
Irvine, California, 92618
GSK Investigational Site
Jackson, Mississippi, 39202
GSK Investigational Site
Jacksonville, Florida, 32207
GSK Investigational Site
Kerrville, Texas, 78028
GSK Investigational Site
Kirkland, Washington, 98034
GSK Investigational Site
Knoxville, Tennessee, 37920
GSK Investigational Site
Lakewood, Colorado, 80401
GSK Investigational Site
Lawrenceville, Georgia, 30045
GSK Investigational Site
Lilburn, Georgia, 30047
GSK Investigational Site
Little Rock, Arkansas, 72205
GSK Investigational Site
Long Beach, California, 90806
GSK Investigational Site
Long Beach, California, 90808
GSK Investigational Site
Los Angeles, California, 90025
GSK Investigational Site
Los Angeles, California, 90048
GSK Investigational Site
Madison, Wisconsin, 53792
GSK Investigational Site
Medford, Oregon, 97504
GSK Investigational Site
Metairie, Louisiana, 70002
GSK Investigational Site
Miami, Florida, 33136
GSK Investigational Site
Miami, Florida, 33176
GSK Investigational Site
Milwaukee, Wisconsin, 53209-0996
GSK Investigational Site
Milwaukee, Wisconsin, 53219
GSK Investigational Site
Milwaukee, Wisconsin, 53226
GSK Investigational Site
Mobile, Alabama, 36608
GSK Investigational Site
Nashville, Tennessee, 37203-1424
GSK Investigational Site
New York, New York, 10021
GSK Investigational Site
Newark, New Jersey, 07103-2499
GSK Investigational Site
North Dartmouth, Massachusetts, 02747
GSK Investigational Site
Oklahoma City, Oklahoma, 73120
GSK Investigational Site
Orange, California, 92868
GSK Investigational Site
Orangeburg, South Carolina, 29118
GSK Investigational Site
Orlando, Florida, 32806
GSK Investigational Site
Overland Park, Kansas, 66210
GSK Investigational Site
Papillion, Nebraska, 68046
GSK Investigational Site
Philadelphia, Pennsylvania, 19107
GSK Investigational Site
Philadelphia, Pennsylvania, 19143
GSK Investigational Site
Richmond, Virginia, 23229
GSK Investigational Site
Rochester, New York, 14618
GSK Investigational Site
San Antonio, Texas, 78229
GSK Investigational Site
Sarasota, Florida, 34233
GSK Investigational Site
Shreveport, Louisiana, 71104
GSK Investigational Site
Shreveport, Louisiana, 71105
GSK Investigational Site
South Burlington, Vermont, 05403
GSK Investigational Site
South Miami, Florida, 33143
GSK Investigational Site
Spartanburg, South Carolina, 29303
GSK Investigational Site
Spring Valley, California, 91978
GSK Investigational Site
St Louis, Missouri, 63141
GSK Investigational Site
Stockton, California, 95207
GSK Investigational Site
Tallahassee, Florida, 32308
GSK Investigational Site
Tampa, Florida, 33613
GSK Investigational Site
Upland, Pennsylvania, 19013
GSK Investigational Site
Warrensburg, Missouri, 64093
GSK Investigational Site
Waterbury, Connecticut, 06708
GSK Investigational Site
West Allis, Wisconsin, 53227
GSK Investigational Site
Wheat Ridge, Colorado, 80033
GSK Investigational Site
Winston-Salem, North Carolina, 27157

Other trials in United States

Peru2 sites

GSK Investigational Site
Lima, Lima Province, Lima 1
GSK Investigational Site
San Isidro, Lima region, Lima 27

Other trials in Peru

Puerto Rico2 sites

GSK Investigational Site
Hato Rey, Puerto Rico, 00917
GSK Investigational Site
Ponce, Puerto Rico, 00716

Other trials in Puerto Rico

Kenya1 site

GSK Investigational Site
Nairobi, 00200

Other trials in Kenya

About this study

Official title: Randomized, Double-Blind Comparison of Advair 100/50 BID vs Salmeterol BID vs Albuterol QID in Subjects With ARG/ARG Genotype 12 Years of Age and Older With Presistent Asthma on Short-Acting Beta2-Agonists Alone

This study may last up to 36-38 weeks. Patients will visit the clinic 11 times. A blood sample will be taken at Visit 1 to look at subjects' genes. Breathing tests will be done during the study. Study medicines and procedures will be provided at no cost. Patients will be treated with VENTOLIN (8 wks), ATROVENT (8 wks), then ADVAIR or SEREVENT (16 wks). ADVAIR and SEREVENT are FDA approved for the treatment of asthma in patients 4 years of age and older.

Read the detailed description

A Randomized, Parallel Group, Double-Blind, Comparative Trial Assessing Lung Function and Other Measures of Asthma Control in Adults and Adolescents, at least 12 Years of Age, with Persistent Asthma, Who Have Either a B16-Arg/Arg, a B16-Gly/Gly or a B-16 Arg/Gly Genotype and are Treated With Fluticasone Propionate/Salmeterol DISKUS™ Combination Product 100/50mcg or Salmeterol DISKUS 50 mcg BID

Conditions: Asthma
Being tested: fluticasone propionate/salmeterol, salmeterol xinafoate
Keywords: genotype, Salmeterol, ADVAIR
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/salmeterolDrug
salmeterol xinafoateDrug
Also called fluticasone propionate/salmeterol

What is being measured

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

Evaluate lung function by testing morning peak expiratory flow in patients with a B16 Arg/Arg genotype compared to patients with a B16 Gly/Gly genotype over 16 weeks of treatment with ADVAIR or SEREVENT

Secondary outcomes (1)

Evaluate lung function by testing morning peak expiratory flow in patients with a Arg/Gly genotype compared to patients with a Arg/Arg or a Gly/Gly genotype over 16 weeks of treatment with ADVAIR and/or SEREVENT

Timeline

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

Oct 2004Jan 2007

First posted4 Feb 2005 (estimated)
Study startOct 2004
Primary completionJan 2007
Study completionJan 2007

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
Enrolment: 547 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00102882
Sponsor's protocol ID: SFA100062
Status last verified: Feb 2017
First submitted: 3 Feb 2005
Last updated: 3 Feb 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

Bleecker ER, Nelson HS, Kraft M, Corren J, Meyers DA, Yancey SW, Anderson WH, Emmett AH, Ortega HG. Beta2-receptor polymorphisms in patients receiving salmeterol with or without fluticasone propionate. Am J Respir Crit Care Med. 2010 Apr 1;181(7):676-87. doi: 10.1164/200809-1511OC. Epub 2009 Nov 12.
PubMed 19910613

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 3 Feb 2017. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Randomized, Double-Blind Comparison of Advair 100/50 BID vs Salmeterol BID vs Albuterol QID in Subjects With ARG/ARG Genotype 12 Years of Age and Older With Presistent Asthma on Short-Acting Beta2-Agonists Alone
ClinicalTrials.gov ID: NCT00102882
Acronym / sponsor ID: SFA100062
Conditions: Asthma
Keywords: genotype, Salmeterol, ADVAIR
Phase: Phase 4
Study type: Interventional
Recruitment status: Completed
Enrolment: 547 participants (actual)
Lead sponsor: GlaxoSmithKlineIndustry (pharma, biotech, devices)
Study start: Oct 2004
Primary completion: Jan 2007 (actual)
Study completion: Jan 2007 (actual)
First posted: 4 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.

Detailed description

Study design

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

Who may qualify

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

Key inclusion criteria (2 listed)

Diagnosis of persistent asthma for 3 months.
Use of short-acting beta-agonist medication like VENTOLIN.

Key exclusion criteria (3 listed)

Hospitalization for asthma 6 months before study.
Other serious diseases like congestive heart failure, uncontrolled hypertension, TB.
Current use of inhaled or oral corticosteroids.

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	Drug	–
salmeterol xinafoateAlso: fluticasone propionate/salmeterol	Drug	–

Primary outcome

Evaluate lung function by testing morning peak expiratory flow in patients with a B16 Arg/Arg genotype compared to patients with a B16 Gly/Gly genotype over 16 weeks of treatment with ADVAIR or SEREVENT

1 secondary outcome

Evaluate lung function by testing morning peak expiratory flow in patients with a Arg/Gly genotype compared to patients with a Arg/Arg or a Gly/Gly genotype over 16 weeks of treatment with ADVAIR and/or SEREVENT

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 3 Feb 2017.
Derived from this study: PubMed 19910613Bleecker ER, Nelson HS, Kraft M, Corren J, Meyers DA, Yancey SW, Anderson WH, Emmett AH, Ortega HG. Beta2-receptor polymorphisms in patients receiving salmeterol with or without fluticasone propionate. Am J Respir Crit Care Med. 2010 Apr 1;181(7):676-87. doi: 10.1164/200809-1511OC. Epub 2009 Nov 12.
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

91 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 fluticasone propionate/salmeterol and salmeterol xinafoate in people with Asthma, run by GlaxoSmithKline at 91 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 2 inclusion and 3 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 3 Feb 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 91 sites in United States, Peru, Puerto Rico, Kenya. 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?

Evaluate lung function by testing morning peak expiratory flow in patients with a B16 Arg/Arg genotype compared to patients with a B16 Gly/Gly genotype over 16 weeks of treatment with ADVAIR or SEREVENT. 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 NCT00102882, 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 3 Feb 2017.