Comparison of New Combination Inhaler (FlutiForm HFA MDI 100/10 µg) Versus Fluticasone and Formoterol Administered Alone, and Placebo, in Patients With Asthma
NCT ID: NCT00393991
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
475 participants
INTERVENTIONAL
2006-07-31
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 100/10 μg
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.
2
Fluticasone 100 μg
Fluticasone propionate 100
Fluticasone 100ug is a HFA pMDI that delivers 50ug of Fluticasone propionate per actuation. Patients will take 2 actuations BID for 12 weeks.
3
Formoterol 10 μg
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.
4
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 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 100
Fluticasone 100ug is a HFA pMDI that delivers 50ug 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.
Placebo
Placebo is a HFA pMDI that delivers placebo aerosol. Patients will take 2 actuations BID for 12 weeks.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* For steroid-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.
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 Site
Pell City, Alabama, United States
Research Site
Scottsdale, Arizona, United States
Research Site
Cypress, California, United States
Research Site
Encinitas, California, United States
Research Site
Fountain Valley, California, United States
Research Center
Los Angeles, California, United States
Research Site
Mission Hills, California, United States
Research Site
Centennial, Colorado, United States
Research Site
Colorado Springs, Colorado, United States
Research Site
Englewood, Colorado, United States
Research Site
Waterbury, Connecticut, United States
Research Site
Aventura, Florida, United States
Research Site
Gainesville, Florida, United States
Research Center
Largo, Florida, United States
Research Site
Miami, Florida, United States
Research Site
Ocala, Florida, United States
Research Site
Tallahassee, Florida, United States
Research Site
Conyers, Georgia, United States
Research Site
Lawrenceville, Georgia, United States
Research Site
Round Lake Beach, Illinois, United States
Research Site
Indianapolis, Indiana, United States
Research Site
Bethesda, Maryland, United States
Research Site
Brockton, Massachusetts, United States
Research Site
Cherry Hill, New Jersey, United States
Research Site
Forked River, New Jersey, United States
Research Site
Asheville, North Carolina, United States
Research Center
Elizabeth City, North Carolina, United States
Research Site
Elizabeth City, North Carolina, United States
Research Site
Columbus, Ohio, United States
Research Site
Toledo, Ohio, United States
Research Site
Okalahoma City, Oklahoma, United States
Research Site
Oklahoma City, Oklahoma, United States
Research Site
Oklahoma City, Oklahoma, United States
Research Site
Eugene, Oregon, United States
Research Site
Lake Oswego, Oregon, United States
Research Site
Medford, Oregon, United States
Research Site
Philadelphia, Pennsylvania, United States
Research Site
Pittsburgh, Pennsylvania, United States
Research Site
Scranton, Pennsylvania, United States
Research Site
Austin, Texas, United States
Research Site
Dallas, Texas, United States
Research Site
El Paso, Texas, United States
Research Site
Houston, Texas, United States
Research Site
McKinney, Texas, United States
Research Site
Round Rock, Texas, United States
Research Site
San Antonio, Texas, United States
Research Site
Bellingham, Washington, United States
Research Site
Ajax, Ontario, Canada
Research Site
Greater Sudbury, Ontario, Canada
Research Site
Greater Sudbury, Ontario, Canada
Research Site
Mississauga, Ontario, Canada
Research Site
Ottawa, Ontario, Canada
Research Site
Point Edward, Ontario, Canada
Research Site
Toronto, Ontario, Canada
Research Site
Toronto, Ontario, Canada
Research Site
Saint Romuald, Quebec, Canada
Research Site
St. John's, , Canada
Countries
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References
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Nathan RA, D'Urzo A, Blazhko V, Kaiser K. Safety and efficacy of fluticasone/formoterol combination therapy in adolescent and adult patients with mild-to-moderate asthma: a randomised controlled trial. BMC Pulm Med. 2012 Oct 18;12:67. doi: 10.1186/1471-2466-12-67.
Other Identifiers
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SKY2028-3-001
Identifier Type: -
Identifier Source: org_study_id
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