Comparison of New Combination Inhaler (FlutiForm HFA MDI 100/10 µg) Versus Fluticasone & Formoterol Administered Alone in Patients With Asthma

Completed · Phase 3

Conditions studied: Asthma

In brief

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.

Key facts

Study ID

NCT00394199

Run by

SkyePharma AG

People needed

357

Starts

2006-06-01

Expected to finish

2008-02-01

Last updated by the study team

2011-06-23

Who can join

Age: 12 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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 nebulized 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.

You may not qualify if…

• 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.

Where it is running

• Research Site — Birmingham, Alabama, United States
• Research Site — Mission Viejo, California, United States
• Research Site — Orange, California, United States
• Research Site — San Jose, California, United States
• Research Site — Vista, California, United States
• Research Site — Denver, Colorado, United States
• Research Site — Lilburn, Georgia, United States
• Research Site — Savannah, Georgia, United States
• Research Site — Park City, Kansas, United States
• Research Site — Bethesda, Maryland, United States
• Research Site — North Dartmouth, Massachusetts, United States
• Research Center — Stevensville, Michigan, United States
• Research Site — Elizabeth, New Jersey, United States
• Research Center — Rochester, New York, United States
• Research Site — Asheville, North Carolina, United States
• Research Site — Raleigh, North Carolina, United States
• Research Site — Cincinnati, Ohio, United States
• Research Site — Sylvania, Ohio, United States
• Research Site — Easton, Pennsylvania, United States
• Research Site — Lincoln, Rhode Island, United States
• Research Site — Greenville, South Carolina, United States
• Research Site — Chattanooga, Tennessee, United States
• Research Site — El Paso, Texas, United States
• Research Site — Houston, Texas, United States
• Research Site — Katy, Texas, United States

Full record on ClinicalTrials.gov

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