During this study, eligible children 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.

Condition	Intervention	Phase
Bronchospasm Asthma, Exercise-Induced	Drug: Fluticasone propionate/salmeterol  Drug: Fluticasone propionate	Phase IV

Further Study Details: 

Primary Outcomes: 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: Daily lung function tests and subject assessed diary measures analyzed over the 4-week treatment.
Expected Total Enrollment:  230

Ages Eligible for Study:  4 Years   -   17 Years,  Genders Eligible for Study:  Both

Criteria

Inclusion Criteria:

• Have been diagnosed with persistent asthma for 3 months or longer.
• Experience worsened asthma symptoms during physical activity.
• Are/have been using an inhaled steroid for the last 4 weeks or longer (such as Aerobid, Azmacort, Flovent, Pulmicort, QVAR, or Vanceril).

Exclusion Criteria:

• Have 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.
• Have been admitted to a hospital within the last 6 months due to asthma symptoms.
• Have 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.

Please refer to this study by ClinicalTrials.gov identifier  NCT00118690

GSK Call Center      877-379-3718 

California
      Onsy Basta, Los Angeles,  California,  90015,  United States; Not yet recruiting
      Kelly Meade, Oakland,  California,  94609,  United States; Recruiting
      Steven Weinstein, Huntington Beach,  California,  92647,  United States; Recruiting
      Robert Ziering, Vista,  California,  92083,  United States; Recruiting
Colorado
      Leon Greos, Englewood,  Colorado,  80112,  United States; Recruiting
Florida
      Richard Lockey, Tampa,  Florida,  33613,  United States; Recruiting
Georgia
      Jack Eades, Savannah,  Georgia,  31405,  United States; Recruiting
      Brad Goodman, Savannah,  Georgia,  31406,  United States; Recruiting
Iowa
      Richard Ahrens C, Iowa City,  Iowa,  52242,  United States; Recruiting
Massachusetts
      William Yee, Boston,  Massachusetts,  02111,  United States; Recruiting
Minnesota
      David Graft, St. Louis Park,  Minnesota,  55416,  United States; Recruiting
Montana
      Wayne Sinclair, Missoula,  Montana,  59804,  United States; Recruiting
New Jersey
      Donald Dvorin, Forked River,  New Jersey,  08731,  United States; Recruiting
Oklahoma
      Martha Tarpay, Oklahoma City,  Oklahoma,  73134,  United States; Recruiting
Oregon
      Jon Van Valkenburg, Medford,  Oregon,  97504,  United States; Recruiting
South Carolina
      Andrew Davidson, Mt. Pleasant,  South Carolina,  29464,  United States; Not yet recruiting
      Richard Sterling, Orangeburg,  South Carolina,  29118,  United States; Recruiting
Texas
      John Meiser, Dallas,  Texas,  75230,  United States; Recruiting
      Laura Somerville, Houston,  Texas,  77054,  United States; Recruiting
Utah
      Edward Campbell, Provo,  Utah,  84604,  United States; Not yet recruiting
Vermont
      Edward Kent, Jr., South Burlington,  Vermont,  05403,  United States; Recruiting
Wisconsin
      Kevin Kelly, Milwaukee,  Wisconsin,  53226,  United States; Recruiting

Study chairs or principal investigators

GSK Clinical Trial,  Study Director,  GlaxoSmithKline   

Study ID Numbers:  SFA100316
Record last reviewed:  July 2005
Last Updated:  July 25, 2005
Record first received:  July 11, 2005
ClinicalTrials.gov Identifier:  NCT00118690
Health Authority: United States: Food and Drug Administration
ClinicalTrials.gov processed this record on 2005-07-26