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:  14 Years   -   17 Years,  Genders Eligible for Study:  Both

Criteria

Inclusion Criteria:

• Participants must have been diagnosed with persistent asthma at least 3 months ago.
• Experience worsened asthma symptoms during physical activity.
• Be using an inhaled steroid (such as Aerobid®, Azmacort®, Flovent®, Pulmicort®, QVAR®, and Vanceril®) for at least the previous 4 weeks.

Exclusion Criteria:

• Have used systemic steroids as either liquid, pill, or injections to treat asthma within the previous 3 months.
• Have only intermittent, seasonal, or exercise-induced asthma alone.
• Have been admitted to a hospital within the previous 6 months due to asthma symptoms.
• Have any poorly controlled medical condition that may make study participation unsafe or inappropriate in the opinion of the study doctor.

The study doctor will evaluate other medical criteria.

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Please refer to this study by ClinicalTrials.gov identifier  NCT00118716

Arkansas
      Karl Sitz, Little Rock,  Arkansas,  72205,  United States; Recruiting
California
      Liberation De Leon, Paramount,  California,  90723,  United States; Recruiting
      Mark Ellis, Orange,  California,  92868,  United States; Recruiting
      Stanley Galant, Orange,  California,  92868,  United States; Recruiting
      Judy Hunter, Torrance,  California,  90503,  United States; Recruiting
      Paul Qaqundah, Huntington Beach,  California,  92647,  United States; Recruiting
      Sheldon Spector, Palmdale,  California,  93551,  United States; Recruiting
      Myloan Vu, San Diego,  California,  92120,  United States; Recruiting
      Andrew Wachtel, Los Angeles,  California,  90048,  United States; Recruiting
Colorado
      Isaac Melamed, Centennial,  Colorado,  80112,  United States; Recruiting
      Grant Olson, Lakewood,  Colorado,  80401,  United States; Recruiting
      David Pearlman, Denver,  Colorado,  80230,  United States; Recruiting
Florida
      Michael Pacin, Miami,  Florida,  33176,  United States; Recruiting
      Ronald Saff, Tallahassee,  Florida,  32308,  United States; Recruiting
Georgia
      Mark Livezey, Lilburn,  Georgia,  30047,  United States; Recruiting
Maryland
      Jonathan Matz, Baltimore,  Maryland,  21236,  United States; Recruiting
Massachusetts
      S. David Miller, North Dartmouth,  Massachusetts,  02747,  United States; Recruiting
Minnesota
      Harold Kaiser, Plymouth,  Minnesota,  55441,  United States; Recruiting
Nebraska
      Linda Ford, Papillion,  Nebraska,  68046,  United States; Recruiting
New Jersey
      Jacob Nutman, Summit,  New Jersey,  07901,  United States; Recruiting
      Darrell L. Southern, Skillman,  New Jersey,  08558,  United States; Recruiting
New York
      Mohammed Kaashmiri, Utica,  New York,  13502,  United States; Recruiting
Ohio
      John Given, Canton,  Ohio,  44718,  United States; Recruiting
Oregon
      James Baker, Lake Oswego,  Oregon,  97035,  United States; Recruiting
      Edward Kerwin, Medford,  Oregon,  97504,  United States; Recruiting
Pennsylvania
      Philip Gallagher, Erie,  Pennsylvania,  16506,  United States; Recruiting
      Ian Paul, Hershey,  Pennsylvania,  17033,  United States; Recruiting
      David Skoner, Pittsburgh,  Pennsylvania,  15212,  United States; Recruiting
South Carolina
      Thomas Harper, Charleston,  South Carolina,  29414,  United States; Recruiting
      Philip Mubarak, Orangeburg,  South Carolina,  29118,  United States; Recruiting
      Ned Rupp, Charleston,  South Carolina,  29406,  United States; Recruiting
Texas
      Mark Millard, Dallas,  Texas,  75246,  United States; Recruiting
Virginia
      Anne-Marie Irani, Richmond,  Virginia,  23219,  United States; Recruiting
Wisconsin
      Gary Steven, Greenfield,  Wisconsin,  53228,  United States; Recruiting

Study chairs or principal investigators

GSK Clinical Trials,  Study Director,  GlaxoSmithKline   

Study ID Numbers:  SFA100314
Record last reviewed:  July 2005
Last Updated:  July 25, 2005
Record first received:  July 11, 2005
ClinicalTrials.gov Identifier:  NCT00118716
Health Authority: United States: Food and Drug Administration
ClinicalTrials.gov processed this record on 2005-07-26