AsthmaPhase 3NCT00920959
Advair Pediatric Once-Daily
A Phase 3 study testing FP 100mcg and FSC 100/50mcg in people with Asthma, run by GlaxoSmithKline at 149 sites in 5 countries.
Trial summary
To demonstrate if once-daily dosing of ADVAIR 100/50 once-daily has superior efficacy and comparable safety compared with FP 100mcg once-daily in pediatric subjects 4 to 11 years of age with asthma. Read more about this study
- Who is it for?
- Ages 4 to 11 years
- Conditions the study is for
- Asthma
- What is being tested?
- FP 100mcg and FSC 100/50mcg
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 908 participants
- Where
- 149 sitesin 5 countries
- Study dates
- Nov 2001to Jan 2004
- Phase
- Phase 3
- 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 4 to 11 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Out-patients
- Asthma diagnosis
- Reversibility
- Short-acting beta-agonist or asthma controlled medication use
Who cannot join
- Life-threatening asthma
- Specified asthma medications
- Chickenpox
- Drug allergy
- Respiratory infections
- Tobacco use
Show all 10Show fewer
- Clinical laboratory abnormalities
- Ophthalmologic conditions
- Investigation medications
- Affiliation with investigator site
Trial locations and contacts
149 sites in 5 countries.
149 sites in 5 countries
United States141 sites
GSK Investigational Site
Albuquerque, New Mexico, 87131
GSK Investigational Site
Altamonte Springs, Florida, 32701
GSK Investigational Site
Altoona, Pennsylvania, 16601
GSK Investigational Site
Asheville, North Carolina, 28801
GSK Investigational Site
Atlanta, Georgia, 30309-7520
GSK Investigational Site
Augusta, Georgia, 30901
GSK Investigational Site
Austin, Texas, 78749
GSK Investigational Site
Barnesville, Georgia, 30204
GSK Investigational Site
Bend, Oregon, 97701
GSK Investigational Site
Berlin, New Jersey, 08009
GSK Investigational Site
Beverly Hills, California, 90212
GSK Investigational Site
Blue Belle, Pennsylvania, 19422
GSK Investigational Site
Brick, New Jersey, 8724
GSK Investigational Site
Buffalo, New York, 14222
GSK Investigational Site
Burke, Virginia, 22015
GSK Investigational Site
Canton, Ohio, 44718
GSK Investigational Site
Centennial, Colorado, 80112
GSK Investigational Site
Charleston, South Carolina, 29407
GSK Investigational Site
Charleston, West Virginia, 25301
GSK Investigational Site
Charlotte, North Carolina, 28204
GSK Investigational Site
Chicago, Illinois, 60612
GSK Investigational Site
Cincinnati, Ohio, 45231
GSK Investigational Site
Cleveland, Ohio, 44106
GSK Investigational Site
Colorado Springs, Colorado, 80907
GSK Investigational Site
Columbia, Missouri, 65212
GSK Investigational Site
Covington, Louisiana, 70433
GSK Investigational Site
Crescent City, California, 95531
GSK Investigational Site
Dallas, Texas, 75230
GSK Investigational Site
Denver, Colorado, 80206
GSK Investigational Site
Denver, Colorado, 80218
GSK Investigational Site
Denver, Colorado, 80230
GSK Investigational Site
Detroit, Michigan, 48202
GSK Investigational Site
Dinuba, California, 93618
GSK Investigational Site
Durham, North Carolina, 27704
GSK Investigational Site
East Orange, New Jersey, 7017
GSK Investigational Site
Edmonds, Washington, 98026
GSK Investigational Site
El Paso, Texas, 79902
GSK Investigational Site
El Paso, Texas, 79925
GSK Investigational Site
Elizabeth City, North Carolina, 27909
GSK Investigational Site
Fresno, California, 93720
GSK Investigational Site
Galveston, Texas, 77555-0188
GSK Investigational Site
Glenview, Illinois, 60025
GSK Investigational Site
Greenfield, Wisconsin, 53228
GSK Investigational Site
Greenville, South Carolina, 29607
GSK Investigational Site
Harrisburg, Pennsylvania, 17110
GSK Investigational Site
Hialeah, Florida, 33013
GSK Investigational Site
Hoffman Estates, Illinois, 60195
GSK Investigational Site
Houston, Texas, 77054
GSK Investigational Site
Houston, Texas, 77065
GSK Investigational Site
Houston, Texas, 77074
GSK Investigational Site
Huntington Beach, California, 92647
GSK Investigational Site
Indianapolis, Indiana, 46208
GSK Investigational Site
Jacksonville, Florida, 32216
GSK Investigational Site
Kansas City, Missouri, 64108
GSK Investigational Site
Knoxville, Tennessee, 37916
GSK Investigational Site
Knoxville, Tennessee, 37917
GSK Investigational Site
Knoxville, Tennessee, 37922
GSK Investigational Site
La Crosse, Wisconsin, 54601
GSK Investigational Site
La Jolla, California, 92093
GSK Investigational Site
Lake Jackson, Texas, 77566
GSK Investigational Site
Lawrence, Kansas, 66047
GSK Investigational Site
Layton, Utah, 84041
GSK Investigational Site
Lewisburg, Pennsylvania, 17837
GSK Investigational Site
Lincoln, Rhode Island, 02865-4208
GSK Investigational Site
Little Rock, Arkansas, 72205
GSK Investigational Site
Liverpool, New York, 13088
GSK Investigational Site
Long Beach, California, 90806
GSK Investigational Site
Louisville, Kentucky, 40222
GSK Investigational Site
Martinez, Georgia, 30907
GSK Investigational Site
Medford, Oregon, 97504
GSK Investigational Site
Metairie, Louisiana, 70001
GSK Investigational Site
Metairie, Louisiana, 70006
GSK Investigational Site
Minneapolis, Minnesota, 55416
GSK Investigational Site
Mission Viejo, California, 92691
GSK Investigational Site
Missoula, Montana, 59804
GSK Investigational Site
Mt. Pleasant, South Carolina, 29464
GSK Investigational Site
Murray, Kentucky, 42071
GSK Investigational Site
Murray, Utah, 84107
GSK Investigational Site
New Braunfels, Texas, 78130
GSK Investigational Site
New Hyde Park, New York, 11042
GSK Investigational Site
Newport Beach, California, 92660
GSK Investigational Site
Newton, Massachusetts, 02462
GSK Investigational Site
Norfolk, Virginia, 23510
GSK Investigational Site
North Dartmouth, Massachusetts, 02747
GSK Investigational Site
Ocean City, New Jersey, 07712
GSK Investigational Site
Oklahoma City, Oklahoma, 73112
GSK Investigational Site
Oklahoma City, Oklahoma, 73120
GSK Investigational Site
Omaha, Nebraska, 68130
GSK Investigational Site
Omaha, Nebraska, 68134
GSK Investigational Site
Orange, California, 92868
GSK Investigational Site
Orlando, Florida, 32801
GSK Investigational Site
Orlando, Florida, 32806
GSK Investigational Site
Ozark, Alabama, 36360
GSK Investigational Site
Palmdale, California, 93551
GSK Investigational Site
Panorama City, California, 91402
GSK Investigational Site
Papillion, Nebraska, 68046
GSK Investigational Site
Paramount, California, 90723
GSK Investigational Site
Park Ridge, Illinois, 60068
GSK Investigational Site
Philadelphia, Pennsylvania, 19135
GSK Investigational Site
Pittsburgh, Pennsylvania, 15202
GSK Investigational Site
Pittsburgh, Pennsylvania, 15241
GSK Investigational Site
Plano, Texas, 75093
GSK Investigational Site
Portland, Oregon, 97213
GSK Investigational Site
Portland, Oregon, 97223
GSK Investigational Site
Pueblo, Colorado, 81008
GSK Investigational Site
Richmond, Virginia, 23229
GSK Investigational Site
Richmond, Virginia, 23298
GSK Investigational Site
Riverside, California, 92506
GSK Investigational Site
Rockville Centre, New York, 11570
GSK Investigational Site
Rolling Hills Estates, California, 90274
GSK Investigational Site
San Antonio, Texas, 78205
GSK Investigational Site
San Antonio, Texas, 78207
GSK Investigational Site
San Antonio, Texas, 78233
GSK Investigational Site
San Diego, California, 92120
GSK Investigational Site
San Francisco, California, 94102
GSK Investigational Site
San Jose, California, 95117
GSK Investigational Site
Sarasota, Florida, 34233
GSK Investigational Site
Savannah, Georgia, 31406
GSK Investigational Site
Sherman Oaks, California, 91403
GSK Investigational Site
Shreveport, Louisiana, 71104
GSK Investigational Site
South Bend, Indiana, 46617
GSK Investigational Site
Spartanburg, South Carolina, 29303
GSK Investigational Site
St Louis, Missouri, 63108
GSK Investigational Site
St Louis, Missouri, 63139
GSK Investigational Site
St Louis, Missouri, 63141
GSK Investigational Site
St. Petersburg, Florida, 33710
GSK Investigational Site
Sunset, Louisiana, 70584
GSK Investigational Site
Tacoma, Washington, 98405
GSK Investigational Site
Tallahassee, Florida, 32308
GSK Investigational Site
Tampa, Florida, 33613
GSK Investigational Site
Taunton, Massachusetts, 02780
GSK Investigational Site
Tucson, Arizona, 85716
GSK Investigational Site
Tucson, Arizona, 85746
GSK Investigational Site
Upland, Pennsylvania, 19013
GSK Investigational Site
Verona, New Jersey, 7044
GSK Investigational Site
Vestal, New York, 13850
GSK Investigational Site
Vista, California, 92083
GSK Investigational Site
Vista, California, 92084
GSK Investigational Site
Walnut Creek, California, 94598
GSK Investigational Site
West Quincy, Massachusetts, 02169
GSK Investigational Site
Winston-Salem, North Carolina, 27103
Argentina3 sites
GSK Investigational Site
Buenos Aires, Buenos Aires, 1425
GSK Investigational Site
Buenos Aires, 1425
GSK Investigational Site
Santa Fe, Santa Fe Province, 3000
Chile2 sites
GSK Investigational Site
Santiago, Región Metro de Santiago
GSK Investigational Site
Viña del Mar, Valparaiso
Puerto Rico2 sites
GSK Investigational Site
Ponce, Puerto Rico, 00716
GSK Investigational Site
San Juan, Puerto Rico, 00935
About this study
Official title: A Stratified, Randomized, Double-blind, Placebo-controlled, Parallel-group, 12 Week Trial Evaluating the Safety and Efficacy of Fluticasone Propionate/Salmeterol DISKUS Combination Product 100/50mcg Once Daily Versus Fluticasone Propionate DISKUS 100mcg Once Daily and Placebo in Symptomatic Pediatric Subjects (4-11 Years) With Asthma
To demonstrate if once-daily dosing of ADVAIR 100/50 once-daily has superior efficacy and comparable safety compared with FP 100mcg once-daily in pediatric subjects 4 to 11 years of age with asthma.
- Conditions
- Asthma
- Being tested
- FP 100mcg, FSC 100/50mcg, Placebo
- Medical subject headings
- Asthma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FP 100mcgDrug
Once-daily dosing
FSC 100/50mcgDrug
Once-daily dosing
PlaceboDrug
Once-daily dosing
| Study group | Role | What they receive |
|---|---|---|
| Fluticasone propionate/salmeterol combination | Experimental | study drug Receives: Drug: FSC 100/50mcg |
| Fluticasone propionate | Experimental | study drug Receives: Drug: FP 100mcg |
| Placebo | Experimental | placebo Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline at endpoint in daily PM PEF
Measured: 12 weeks
Secondary outcomes (1)
Various pulmonary function endpoints
Measured: 12 weeks
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 startNov 2001
- Primary completionJan 2004
- Study completionJan 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 908 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
- NCT00920959
- Sponsor's protocol ID
- SAS30021
- Status last verified
- Sep 2016
- First submitted
- 12 Jun 2009
- Last updated
- 15 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
This study has not been published in the scientific literature.
Study at a glance
From the registry record, last updated by the sponsor on 15 Sep 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Stratified, Randomized, Double-blind, Placebo-controlled, Parallel-group, 12 Week Trial Evaluating the Safety and Efficacy of Fluticasone Propionate/Salmeterol DISKUS Combination Product 100/50mcg Once Daily Versus Fluticasone Propionate DISKUS 100mcg Once Daily and Placebo in Symptomatic Pediatric Subjects (4-11 Years) With Asthma
- ClinicalTrials.gov ID
- NCT00920959
- Acronym / sponsor ID
- SAS30021
- Conditions
- Asthma
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 908 participants (actual)
- Lead sponsor
- GlaxoSmithKlineIndustry (pharma, biotech, devices)
- Study start
- Nov 2001
- Primary completion
- Jan 2004 (actual)
- Study completion
- Jan 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.
To demonstrate if once-daily dosing of ADVAIR 100/50 once-daily has superior efficacy and comparable safety compared with FP 100mcg once-daily in pediatric subjects 4 to 11 years of age with asthma.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Fluticasone propionate/salmeterol combination | Experimental | Drug: FSC 100/50mcgstudy drug |
| Fluticasone propionate | Experimental | Drug: FP 100mcgstudy drug |
| Placebo | Experimental | Drug: Placeboplacebo |
Who may qualify
- Ages
- 4 to 11 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- Out-patients
- Asthma diagnosis
- Reversibility
- Short-acting beta-agonist or asthma controlled medication use
Key exclusion criteria (10 listed)
- Life-threatening asthma
- Specified asthma medications
- Chickenpox
- Drug allergy
- Respiratory infections
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 |
|---|---|---|
| FP 100mcgOnce-daily dosing | Drug | Fluticasone propionate |
| FSC 100/50mcgOnce-daily dosing | Drug | Fluticasone propionate/salmeterol combination |
| PlaceboOnce-daily dosing | Drug | Placebo |
Primary outcome
Change from baseline at endpoint in daily PM PEF
Time frame: 12 weeks
1 secondary outcome
Various pulmonary function endpoints
Time frame: 12 weeks
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 15 Sep 2016.
- BackgroundThis study has not been published in the scientific literature.
- 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
149 sites in 5 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing FP 100mcg and FSC 100/50mcg in people with Asthma, run by GlaxoSmithKline at 149 sites in 5 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 4 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 15 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 149 sites in United States, Argentina, Chile, Puerto Rico, Peru. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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?
Change from baseline at endpoint in daily PM PEF (time frame: 12 weeks). 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 NCT00920959, 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 15 Sep 2016.