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CompletedNCT00118690Updated Sep 23, 2016

A Study Measuring Asthma Control In Pediatric And Adolescent Subjects Whose Asthma Is Worsened By Activity Or Exercise

A Phase 4 interventional study of Fluticasone propionate/salmeterol in Bronchospasm and Activity/Exercise Induced Bronchospasm, sponsored by GlaxoSmithKline. Completed at 51 sites in United States. Open to participants aged 4 Years to 17 Years. Per ClinicalTrials.gov, last updated 2016-09-23.

Sponsored by GlaxoSmithKline · Phase 4, Interventional, and Treatment

Phase
Phase 4
Study type
Interventional
Enrollment
227
Allocation
Randomized
Ages
4 Years to 17 Years
Sex
All
01

Study 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. 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.

02

Conditions studied

  • Bronchospasm
  • Activity/Exercise Induced Bronchospasm

Keywords

  • bronchospasm
  • asthma
03

In context

Bronchial Spasm

44 studies on the registry are indexed under Bronchial Spasm; 4 are open to participants now.

This study's enrollment of 227 is above the median of 70 across 29 interventional studies indexed under Bronchial Spasm.

Browse Bronchial Spasm studies →

Lead sponsor

GlaxoSmithKline is the lead sponsor of 3,650 studies on the registry; 118 are open to participants now.

Of its 264 completed or terminated interventional studies of FDA-regulated products, 241 (91%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
4 Years to 17 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Diagnosed with persistent asthma for 3 months or longer.
  • Experience worsened asthma symptoms during physical activity.
  • Using or used an inhaled for the last 4 weeks or longer (such as Aerobid, Azmacort, Flovent, Pulmicort, QVAR, or Vanceril).

Exclusion criteria

Exclusion criteria:

  • Used systemic 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.
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Corticosteroids (steroids)

Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.

Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.

05

Study design

Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double
Enrollment
227 participants (actual)

Interventions

06

What researchers measure

Primary outcomes

  1. 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.

07

Study locations

51 sites
  • GSK Investigational Site
    Jonesboro, Arkansas 72401, United States
  • GSK Investigational Site
    East Artesia, California 90706, United States
  • GSK Investigational Site
    Huntington Beach, California 92647, United States
  • GSK Investigational Site
    Long Beach, California 90806, United States
  • GSK Investigational Site
    Los Angeles, California 90015, United States
  • GSK Investigational Site
    Madera, California 93638, United States
  • GSK Investigational Site
    Mission Viejo, California 92691, United States
  • GSK Investigational Site
    Oakland, California 94618, United States
  • GSK Investigational Site
    Rolling Hills Est, California 90274, United States
  • GSK Investigational Site
    Vista, California 92083, United States
  • GSK Investigational Site
    Denver, Colorado 80206, United States
  • GSK Investigational Site
    Englewood, Colorado 80112, United States
  • GSK Investigational Site
    Pueblo, Colorado 81008, United States
  • GSK Investigational Site
    Altamonte Springs, Florida 32701, United States
  • GSK Investigational Site
    Delray Beach, Florida 33484, United States
  • GSK Investigational Site
    St. Petersburg, Florida 33710, United States
  • GSK Investigational Site
    Tampa, Florida 33607, United States
  • GSK Investigational Site
    Tampa, Florida 33613, United States
  • GSK Investigational Site
    Lawrenceville, Georgia 30045, United States
  • GSK Investigational Site
    Marietta, Georgia 30062, United States
  • GSK Investigational Site
    Savannah, Georgia 31406, United States
  • GSK Investigational Site
    Savannah, Georgia 31419, United States
  • GSK Investigational Site
    Normal, Illinois 61761, United States
  • GSK Investigational Site
    Iowa City, Iowa 52242, United States
  • GSK Investigational Site
    Louisville, Kentucky 40202, United States
  • GSK Investigational Site
    Sunset, Louisiana 70584, United States
  • GSK Investigational Site
    Bethesda, Maryland 20814, United States
  • GSK Investigational Site
    Boston, Massachusetts 02111, United States
  • GSK Investigational Site
    Robbinsdale, Minnesota 55422, United States
  • GSK Investigational Site
    Missoula, Montana 59804, United States
  • GSK Investigational Site
    Omaha, Nebraska 68114, United States
  • GSK Investigational Site
    Mount Laurel, New Jersey 08054, United States
  • GSK Investigational Site
    Kernersville, North Carolina 27284, United States
  • GSK Investigational Site
    Oklahoma City, Oklahoma 73120, United States
  • GSK Investigational Site
    Medford, Oregon 97504, United States
  • GSK Investigational Site
    Altoona, Pennsylvania 16601, United States
  • GSK Investigational Site
    Pittsburgh, Pennsylvania 15241, United States
  • GSK Investigational Site
    Upland, Pennsylvania 19013, United States
  • GSK Investigational Site
    Charleston, South Carolina 29407, United States
  • GSK Investigational Site
    Mount Pleasant, South Carolina 29464, United States
  • GSK Investigational Site
    Orangeburg, South Carolina 29118, United States
  • GSK Investigational Site
    Nashville, Tennessee 37203-1424, United States
  • GSK Investigational Site
    Dallas, Texas 75230, United States
  • GSK Investigational Site
    El Paso, Texas 79902, United States
  • GSK Investigational Site
    El Paso, Texas 79925, United States
  • GSK Investigational Site
    Houston, Texas 77054, United States
  • GSK Investigational Site
    San Antonio, Texas 78205, United States
  • GSK Investigational Site
    Layton, Utah 84041, United States
  • GSK Investigational Site
    Provo, Utah 84604, United States
  • GSK Investigational Site
    South Burlington, Vermont 05403, United States
  • GSK Investigational Site
    Burke, Virginia 22015, United States
08

References and documents

Individual participant data

Plan to share: Yes — Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 23, 2016, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT00118690
Lead sponsor
GlaxoSmithKline
Responsible party
Sponsor
First posted
Jul 12, 2005
Start date
Dec 2003
Primary completion
Dec 2005
Completion
Dec 2005
Last update
Sep 23, 2016

Study contacts

GSK Clinical Trials
study director · GlaxoSmithKline

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Sep 2016. You cannot join it, but the record below documents what was studied.

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Studies of the drugs tested here: Fluticasone · Salmeterol Xinafoate

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