This research study will compare the treatment effects of three different asthma medications in asthma subjects whose asthma is well controlled when they take fluticasone, an inhaled corticosteroid. The treatments are fluticasone, montelukast (an anti?leukotriene drug), and a combination therapy of fluticasone and salmeterol (a long-acting beta-agonist). Fluticasone, montelukast, and the combination therapy of fluticasone and salmeterol (Advair Diskus®) are all approved for the treatment of asthma. We are looking at whether the three treatments are equally effective for reducing the number and the severity of asthma attacks in subjects with mild to moderately severe asthma.

Condition	Intervention	Phase
Asthma	Drug: fluticasone  Drug: montelukast  Drug: fluticasone/salmeterol combination	Phase IV

Further Study Details: 

Primary Outcomes: Asthma treatment failure
Secondary Outcomes: Pulmonary function; Symptoms; Medication use; Patient measures (questionnaires); Markers of inflammation
Expected Total Enrollment:  495

This trial will attempt to investigate whether asthmatic patients that are well controlled with low-dose twice daily inhaled corticosteroid (ICS) therapy can safely be switched to other modes of controller therapy without loss of asthma control. Patients demonstrating good control on twice-daily low-dose ICS will be randomized to one of three treatment groups: once-daily low-dose ICS (fluticasone), leukotriene receptor antagonist (montelukast), or once-daily combination therapy (fluticasone-salmeterol).

Ages Eligible for Study:  6 Years and above,  Genders Eligible for Study:  Both

Criteria

Inclusion Criteria:

• physician-diagnosed asthma
• age 6 or older
• pre-bronchodilator FEV1 of at least 60% of predicted
• beta-agonist reversibility OR airways hyperreactivity by methacholine challenge
• Juniper Asthma Control Score of 1.5 or greater if not on daily controller
• good current health

Exclusion Criteria:

• current or past smoking (greater than 20 pack-years)
• chronic or current oral steroid therapy
• pregnancy, lack of effective contraception (when appropriate), lactation

Alabama
      University of Alabama at Birmingham, Birmingham,  Alabama,  35233,  United States
Colorado
      National Jewish Hospital, Denver,  Colorado,  80206,  United States
Florida
      Nemour''''s Childrens Center, Jacksonville,  Florida,  32207,  United States
      University of Miami (and University of South Florida in Tampa), Miami,  Florida,  33136,  United States
Georgia
      Emory University, Atlanta,  Georgia,  30322,  United States
Illinois
      Illinois Consortium (Northwestern, Univ. of Chicago, Univ. of Illinois), Chicago,  Illinois,  60611,  United States
Indiana
      Indiana University, Indianapolis,  Indiana,  46202,  United States
Louisiana
      Louisiana State University, New Orleans,  Louisiana,  70112,  United States
Minnesota
      University of Minnesota, Minneapolis,  Minnesota,  55455,  United States
Missouri
      University of Missouri at Kansas City, Kansas City,  Missouri,  64108,  United States
      Washington University, St. Louis,  Missouri,  63110,  United States
New York
      Long Island Jewish Hospital (and North Shore Hospital), New Hyde Park,  New York,  11040,  United States
      New York Consortium (New York Univ. and Columbia Univ.), New York,  New York,  10016,  United States
      New York Medical College, Valhalla,  New York,  10595,  United States
North Carolina
      Duke University School of Medicine, Durham,  North Carolina,  27710,  United States
Ohio
      Ohio State University, Columbus,  Ohio,  43210,  United States
Pennsylvania
      Thomas Jefferson Hospital, Philadelphia,  Pennsylvania,  19107,  United States
Texas
      Baylor College of Medicine, Houston,  Texas,  77030,  United States
Vermont
      Northern New England Consortium (Univ. of Vermont and other locations), Burlington,  Vermont,  05405,  United States

Study chairs or principal investigators

Nicholas Anthonisen, MD,  Study Chair,  University of Winnipeg   

Study ID Numbers:  ALAACRC-03
Last Updated:  September 10, 2005
Record first received:  September 8, 2005
ClinicalTrials.gov Identifier:  NCT00156819
Health Authority: United States: Food and Drug Administration
ClinicalTrials.gov processed this record on 2005-09-13