New Combination Inhaler (FlutiForm HFA MDI 100/10 µg and 250/10 µg) Versus Fluticasone and Formoterol Administered Alone, and Placebo in Patients With Moderate to Severe Asthma
NCT ID: NCT00393952
Last Updated: 2011-06-23
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE3
557 participants
INTERVENTIONAL
2006-06-30
2008-04-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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1
FlutiForm 250/10
Fluticasone propionate/Formoterol fumarate 250/10
FlutiForm 250/10ug is a HFA pMDI that delivers 125ug of Fluticasone propionate per actuation and 5ug of Formoterol fumarate per actuation. Patients will take 2 actuations BID for 12 weeks.
2
FlutiForm 100/10
Fluticasone propionate/Formoterol fumarate 100/10
FlutiForm 100/10ug is a HFA pMDI that delivers 50ug of Fluticasone propionate per actuation and 5ug of Formoterol fumarate per actuation. Patients will take 2 actuations BID for 12 weeks.
3
Fluticasone 250
Fluticasone propionate 250
Fluticasone 250 is a HFA pMDI that delivers 125ug of Fluticasone propionate per actuation. Patients will take 2 actuations BID for 12 weeks.
4
Formoterol 10
Formoterol fumarate 10
Formoterol 10ug is a HFA pMDI that delivers 5ug of Formoterol fumarate per actuation. Patients will take 2 actuations BID for 12 weeks.
5
Placebo
Placebo
Placebo is a HFA pMDI that delivers placebo aerosol. Patients will take 2 actuations BID for 12 weeks.
Interventions
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Fluticasone propionate/Formoterol fumarate 250/10
FlutiForm 250/10ug is a HFA pMDI that delivers 125ug of Fluticasone propionate per actuation and 5ug of Formoterol fumarate per actuation. Patients will take 2 actuations BID for 12 weeks.
Placebo
Placebo is a HFA pMDI that delivers placebo aerosol. Patients will take 2 actuations BID for 12 weeks.
Fluticasone propionate/Formoterol fumarate 100/10
FlutiForm 100/10ug is a HFA pMDI that delivers 50ug of Fluticasone propionate per actuation and 5ug of Formoterol fumarate per actuation. Patients will take 2 actuations BID for 12 weeks.
Fluticasone propionate 250
Fluticasone 250 is a HFA pMDI that delivers 125ug of Fluticasone propionate per actuation. Patients will take 2 actuations BID for 12 weeks.
Formoterol fumarate 10
Formoterol 10ug is a HFA pMDI that delivers 5ug of Formoterol fumarate per actuation. Patients will take 2 actuations BID for 12 weeks.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Documented use of inhaled corticosteroid for at least 4 weeks prior to Screening Visit Demonstrate FEV-1 of 40-80% of predicted normal values at Screening and Baseline Visit.
* Documented reversibility of 15% within 12 months of Screening visit 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.
Exclusion Criteria
* History of systemic corticosteroid medication within 3 months before 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.
12 Years
ALL
No
Sponsors
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SkyePharma AG
INDUSTRY
Responsible Party
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Skyepharma AG
Locations
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Research Center
Pell City, Alabama, United States
Research Site
Glendale, Arizona, United States
Research Center
Phoenix, Arizona, United States
Research Site
Phoenix, Arizona, United States
Research Site
Tucson, Arizona, United States
Research Site
Jonesboro, Arkansas, United States
Research Site
Little Rock, Arkansas, United States
Research Site
Burbank, California, United States
Research Site
Fresno, California, United States
Research Site
Long Beach, California, United States
Research Site
Los Angeles, California, United States
Research Center
Los Angeles, California, United States
Research Site
Los Angeles, California, United States
Research Site
Mission Viejo, California, United States
Research Site
Monterey Park, California, United States
Research Site
Palmdale, California, United States
Research Site
Sacramento, California, United States
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San Diego, California, United States
Research Site
San Diego, California, United States
Research Site
San Jose, California, United States
Research Center
Gainesville, Florida, United States
Research Site
Hialeah, Florida, United States
Research Site
Ormond Beach, Florida, United States
Research Center
Panama City, Florida, United States
Research Site
Pensacola, Florida, United States
Research Site
Tampa, Florida, United States
Research Center
Congers, Georgia, United States
Research Site
Savannah, Georgia, United States
Research Site
Round Lake Beach, Illinois, United States
Research Site
Louisville, Kentucky, United States
Research Site
Baltimore, Maryland, United States
Research Site
North Dartmouth, Massachusetts, United States
Research Site
Taunton, Massachusetts, United States
Research Center
Minneapolis, Minnesota, United States
Research Site
Minneapolis, Minnesota, United States
Research Site
Plymouth, Minnesota, United States
Research Site
St Louis, Missouri, United States
Research Site
Bozeman, Montana, United States
Research Site
Omaha, Nebraska, United States
Research Site
Las Vegas, Nevada, United States
Research Site
Brick, New Jersey, United States
Research Site
Mount Laurel, New Jersey, United States
Research Site
Skillman, New Jersey, United States
Research Site
Tinton Falls, New Jersey, United States
Research Site
Rockville Centre, New York, United States
Research Site
Oklahoma City, Oklahoma, United States
Research Site
Ashland, Oregon, United States
Research Site
Medford, Oregon, United States
Research Center
Portland, Oregon, United States
Research Center
Upland, Pennsylvania, United States
Research Site
Lincoln, Rhode Island, United States
Research Center
Anderson, South Carolina, United States
Research Site
Greenville, South Carolina, United States
Research Site
Austin, Texas, United States
Research Site
Dallas, Texas, United States
Research Site
El Paso, Texas, United States
Research Center
Fort Worth, Texas, United States
Research Site
San Antonio, Texas, United States
Research Site
San Antonio, Texas, United States
Research Site
Richmond, Virginia, United States
Research Site
Tacoma, Washington, United States
Research Site
Milwaukee, Wisconsin, United States
Research Center
Ponce, , Puerto Rico
Countries
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Other Identifiers
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SKY2028-3-004
Identifier Type: -
Identifier Source: org_study_id
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