To compare the efficacy and safety of the fixed combination asthma drug Flutiform HFA MDI
with its two components administered alone, fluticasone propionate and formoterol fumarate,
in adult and adolescent patients with mild to moderate asthma.
- Ages eligible for study: 12 years and above
- Genders eligible for study: both
- Prior steriod use: steroid-requiring or steroid-free
Inclusion Criteria:
- History of asthma for at least 12 months
- For steriod-requiring patients, documented use of inhaled corticosteroid for at least
4 weeks prior to Screening Visit
- For steroid-free patients, no history of inhaled steroid asthma medication for at
least 12 weeks prior to Screening Visit
- Demonstrate FEV-1 of 60-85% of predicted normal values at Screening and Baseline
Visit
- Documented reversibility of 15% within 12 months of Screening or at Screening Visit
(15% increase from pre-FEV-1 levels following albuterol inhalation or neubulized
albuterol administration)
- Symptoms of asthma during Run-in
- Females of childbearing potential must have a negative urine pregnancy test at
Screening and Baseline Visits. Females are eligible only if they are not pregnant or
lactating, and are either sterile, or using acceptable methods of contraception.
- Must otherwise be healthy
- Provide written informed consent. Wishes of minors must be respected.
Exclusion Criteria:
Patients will not be eligible for the study if they meet any of the following criteria:
- Life-threatening asthma within the past year or during the Run-In Period.
- History of systemic corticosteroid medication within 3 months before the Screening
Visit.
- History of omalizumab use within past 6 months.
- History of leukotriene receptor antagonist use, e. g., montelukast, within past week.
- Current evidence or history of any clinically significant disease or abnormality
including uncontrolled hypertension, uncontrolled coronary artery disease, congestive
heart failure, myocardial infarction, or cardiac dysrhythmia.
- Upper or lower respiratory infection within 4 weeks prior to Screening Visit or during
Run-In Period.
- Significant, non-reversible, pulmonary disease (e. g., chronic obstructive pulmonary
disease [COPD], cystic fibrosis, bronchiectasis).
- Known Human Immunodeficiency Virus (HIV)-positive status.
- Smoking history equivalent to "10 pack years".
- Current smoking history within 12 months prior to Screening Visit.
- Current evidence or history of alcohol and/or substance abuse within 12 months prior
to Screening Visit.
- Patients who are confined in institution.
Research Site, Birmingham, Alabama 35242, United States
Research Site, Vancouver, British Columbia V5Z 3J5, Canada
Research Site, Kelowna, British Columbia V1Y 9L8, Canada
Research Site, Orange, California 92868, United States
Research Site, San Jose, California 95117, United States
Research Site, Vista, California 92083, United States
Research Site, Mission Viejo, California 92691, United States
Research Site, Denver, Colorado 80230, United States
Research Site, Lilburn, Georgia 30047, United States
Research Site, Savannah, Georgia 31406, United States
Research Site, Park City, Kansas 67219, United States
Research Site, Bethesda, Maryland 20814, United States
Research Site, N. Dartmouth, Massachusetts 02747, United States
Research Center, Stevensville, Michigan 49127, United States
Research Site, Elizabeth, New Jersey 07202, United States
Research Center, Rochester, New York 14618, United States
Research Site, Asheville, North Carolina 28801, United States
Research Site, Raleigh, North Carolina 27607, United States
Research Site, Cincinnati, Ohio 45242, United States
Research Site, Sylvania, Ohio 43560, United States
Research Site, Hamilton, Ontario L8N 1Y2, Canada
Research Site, Toronto, Ontario M4P 1P2, Canada
Research Site, London, Ontario N6A 1V2, Canada
Research Site, Mississauga, Ontario L4W 1N2, Canada
Research Site, Oshawa, Ontario L1H 1B9, Canada
Research Center, London, Ontario N5X 4E7, Canada
Research Site, Easton, Pennsylvania 18045, United States
Research Site, Longueuil, Quebec J4N 1E1, Canada
Research Site, Trois Rivieres, Quebec G8T 7A1, Canada
Research Site, Saint Foy, Quebec G1V 4M6, Canada
Research Site, Montreal, Quebec H2L 2W5, Canada
Research Site, Lincoln, Rhode Island 02906, United States
Research Site, Greenville, South Carolina 29605, United States
Research Site, Chattanooga, Tennessee 37421, United States
Research Site, Katy, Texas 77450, United States
Research Site, Waco, Texas 76712, United States
Research Site, New Braunfels, Texas 78130, United States
Research Site, El Paso, Texas 79902, United States
Research Site, Houston, Texas 77054, United States
Research Site, South Burlington, Vermont 05403, United States
Research Site, Greenfield, Wisconsin 53228, United States
