BronchospasmPhase 4NCT00118690
A Study Measuring Asthma Control In Pediatric And Adolescent Subjects Whose Asthma Is Worsened By Activity Or Exercise
A Phase 4 study testing Fluticasone propionate/salmeterol in people with Bronchospasm and Activity/Exercise Induced Bronchospasm, run by GlaxoSmithKline at 51 sites in United States.
Trial summary
During this study, your child will need to attend up to 5 office visits and maintain regular telephone contact with the clinic. Certain office visits will include physical exams, medical history review, exercise challenge test (walking/running on a treadmill), electrocardiogram (ECG) tests, and lung function tests. Read more about this study
- Who is it for?
- Ages 4 to 17 years
- Conditions the study is for
- Bronchospasm, Activity/Exercise Induced Bronchospasm
- What is being tested?
- Fluticasone propionate/salmeterol
- How many people
- 227 participants
- Where
- 51 sitesUnited States
- Study dates
- Dec 2003to Dec 2005
- 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 4 to 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Diagnosed with persistent asthma for 3 months or longer.
- Experience worsened asthma symptoms during physical activity.
- Using or used an inhaled steroid for the last 4 weeks or longer (such as Aerobid, Azmacort, Flovent, Pulmicort, QVAR, or Vanceril).
Who cannot join
- Used systemic steroids as either liquids, pills, or injections to treat asthma within the last 3 months.
- Have only intermittent, seasonal, or exercise induced asthma, and not persistent asthma.
- Admitted to a hospital within the last 6 months due to asthma symptoms.
- Any poorly controlled medical conditions that may make study participation unsafe or inappropriate in the opinion of the study physician (such as cystic fibrosis, congenital heart disease, insulin dependent diabetes, glaucoma, drug allergies, etc.).
- The study physician will evaluate other medical criteria.
Trial locations and contacts
51 sites in 1 country.
51 sites in 1 country
United States51 sites
GSK Investigational Site
Altamonte Springs, Florida, 32701
GSK Investigational Site
Altoona, Pennsylvania, 16601
GSK Investigational Site
Bethesda, Maryland, 20814
GSK Investigational Site
Boston, Massachusetts, 02111
GSK Investigational Site
Burke, Virginia, 22015
GSK Investigational Site
Charleston, South Carolina, 29407
GSK Investigational Site
Dallas, Texas, 75230
GSK Investigational Site
Delray Beach, Florida, 33484
GSK Investigational Site
Denver, Colorado, 80206
GSK Investigational Site
East Artesia, California, 90706
GSK Investigational Site
El Paso, Texas, 79902
GSK Investigational Site
El Paso, Texas, 79925
GSK Investigational Site
Englewood, Colorado, 80112
GSK Investigational Site
Houston, Texas, 77054
GSK Investigational Site
Huntington Beach, California, 92647
GSK Investigational Site
Iowa City, Iowa, 52242
GSK Investigational Site
Jonesboro, Arkansas, 72401
GSK Investigational Site
Kernersville, North Carolina, 27284
GSK Investigational Site
Lawrenceville, Georgia, 30045
GSK Investigational Site
Layton, Utah, 84041
GSK Investigational Site
Long Beach, California, 90806
GSK Investigational Site
Los Angeles, California, 90015
GSK Investigational Site
Louisville, Kentucky, 40202
GSK Investigational Site
Madera, California, 93638
GSK Investigational Site
Marietta, Georgia, 30062
GSK Investigational Site
Medford, Oregon, 97504
GSK Investigational Site
Mission Viejo, California, 92691
GSK Investigational Site
Missoula, Montana, 59804
GSK Investigational Site
Mount Laurel, New Jersey, 08054
GSK Investigational Site
Mt. Pleasant, South Carolina, 29464
GSK Investigational Site
Nashville, Tennessee, 37203-1424
GSK Investigational Site
Normal, Illinois, 61761
GSK Investigational Site
Oakland, California, 94618
GSK Investigational Site
Oklahoma City, Oklahoma, 73120
GSK Investigational Site
Omaha, Nebraska, 68114
GSK Investigational Site
Orangeburg, South Carolina, 29118
GSK Investigational Site
Pittsburgh, Pennsylvania, 15241
GSK Investigational Site
Provo, Utah, 84604
GSK Investigational Site
Pueblo, Colorado, 81008
GSK Investigational Site
Robbinsdale, Minnesota, 55422
GSK Investigational Site
Rolling Hills Est, California, 90274
GSK Investigational Site
San Antonio, Texas, 78205
GSK Investigational Site
Savannah, Georgia, 31406
GSK Investigational Site
Savannah, Georgia, 31419
GSK Investigational Site
South Burlington, Vermont, 05403
GSK Investigational Site
St. Petersburg, Florida, 33710
GSK Investigational Site
Sunset, Louisiana, 70584
GSK Investigational Site
Tampa, Florida, 33607
GSK Investigational Site
Tampa, Florida, 33613
GSK Investigational Site
Upland, Pennsylvania, 19013
GSK Investigational Site
Vista, California, 92083
About this study
Official title: A Stratified, Multicenter, Randomized, Double-Blind, Parallel Group, 4-Week Comparison of Fluticasone Propionate/Salmeterol DISKUS Combination Product 100/50mcg BID Versus Fluticasone Propionate DISKUS 100mcg BID in Pediatric and Adolescent Subjects With Activity-Induced Bronchospasm
During this study, your child will need to attend up to 5 office visits and maintain regular telephone contact with the clinic. Certain office visits will include physical exams, medical history review, exercise challenge test (walking/running on a treadmill), electrocardiogram (ECG) tests, and lung function tests. All study related medications and medical examinations are provided at no cost. All study drugs are currently available by prescription to patients 4 years and older.
- Being tested
- Fluticasone propionate/salmeterol
- Keywords
- bronchospasm, asthma
- Medical subject headings
- Bronchial Spasm, Motor Activity, Asthma, Exercise-Induced, Asthma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fluticasone propionate/salmeterolDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in maximal decline from baseline in lung function following exercise challenge after 4-weeks of double-blind treatment compared to decline in lung function before treatment.
Secondary outcomes (1)
Daily lung function tests and subject assessed diary measures analyzed over the 4-week treatment.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jul 2005 (estimated)
- Study startDec 2003
- Primary completionDec 2005
- Study completionDec 2005
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for BronchospasmStudies 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
- 227 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
- NCT00118690
- Sponsor's protocol ID
- SFA100316
- Status last verified
- Sep 2016
- First submitted
- 1 Jul 2005
- Last updated
- 23 Sep 2016
- 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.
Study at a glance
From the registry record, last updated by the sponsor on 23 Sep 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Stratified, Multicenter, Randomized, Double-Blind, Parallel Group, 4-Week Comparison of Fluticasone Propionate/Salmeterol DISKUS Combination Product 100/50mcg BID Versus Fluticasone Propionate DISKUS 100mcg BID in Pediatric and Adolescent Subjects With Activity-Induced Bronchospasm
- ClinicalTrials.gov ID
- NCT00118690
- Acronym / sponsor ID
- SFA100316
- Keywords
- bronchospasm, asthma
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 227 participants (actual)
- Lead sponsor
- GlaxoSmithKlineIndustry (pharma, biotech, devices)
- Study start
- Dec 2003
- Primary completion
- Dec 2005 (actual)
- Study completion
- Dec 2005 (actual)
- First posted
- 12 Jul 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.
During this study, your child will need to attend up to 5 office visits and maintain regular telephone contact with the clinic. Certain office visits will include physical exams, medical history review, exercise challenge test (walking/running on a treadmill), electrocardiogram (ECG) tests, and lung function tests. All study related medications and medical examinations are provided at no cost. All study drugs are currently available by prescription to patients 4 years and older.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
Who may qualify
- Ages
- 4 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- Diagnosed with persistent asthma for 3 months or longer.
- Experience worsened asthma symptoms during physical activity.
- Using or used an inhaled steroid for the last 4 weeks or longer (such as Aerobid, Azmacort, Flovent, Pulmicort, QVAR, or Vanceril).
Key exclusion criteria (5 listed)
- Used systemic steroids as either liquids, pills, or injections to treat asthma within the last 3 months.
- Have only intermittent, seasonal, or exercise induced asthma, and not persistent asthma.
- Admitted to a hospital within the last 6 months due to asthma symptoms.
- Any poorly controlled medical conditions that may make study participation unsafe or inappropriate in the opinion of the study physician (such as cystic fibrosis, congenital heart disease, insulin dependent diabetes, glaucoma, drug allergies, etc.).
- The study physician will evaluate other medical criteria.
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 | – |
Primary outcome
Change in maximal decline from baseline in lung function following exercise challenge after 4-weeks of double-blind treatment compared to decline in lung function before treatment.
1 secondary outcome
Daily lung function tests and subject assessed diary measures analyzed over the 4-week 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 23 Sep 2016.
- http://www.findclinicalstudy.comLink 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 Bronchospasm
RecruitingPhase 3
A Study to Compare Safety of 4 Weeks Exposure to Propellants Hydrofluoroalkane 1,1-difluoroethane (HFA-152a) and HFA-1,1,1,2-tetrafluoroethane (134a)
Asthma
Not yet recruitingObservational study
Perioperative Respiratory Adverse Events in Cleft Lip and Palate Surgery: Incidence, Risk Factors, and Clinical Scoring
Cleft Palate, Cleft Lip
RecruitingObservational study
Swiss Paediatric Airway Cohort
Asthma, Wheezing
Recruiting
Driving Pressure During Surgeries With High Risk for Postoperative Pulmonary Complications
Postoperative Pulmonary Atelectasis, Postoperative Pulmonary Complications
Recruiting
Intraoperative Paravertebral Block and Postoperative Complications
Video-assisted Thoracoscopic Surgery (VATS), Lung Cancer (Diagnosis)
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
51 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 in people with Bronchospasm and Activity/Exercise Induced Bronchospasm, run by GlaxoSmithKline at 51 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 3 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 23 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 51 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?
Change in maximal decline from baseline in lung function following exercise challenge after 4-weeks of double-blind treatment compared to decline in lung function before treatment.. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 23 Sep 2016.