Comparison of New Combination Inhaler (FlutiForm HFA MDI 100/10 µg) Versus Fluticasone & Formoterol Administered Alone in Patients With Asthma
NCT ID: NCT00394199
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
357 participants
INTERVENTIONAL
2006-06-30
2008-02-29
Brief Summary
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A 12-Week Study To Assess The Safety Of Fluticasone Propionate/Salmeterol 100/50 Hydrofluoroalkane (HFA) Versus Fluticasone Propionate 100 HFA In Children With Asthma
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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 100/10ug
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
Fluticasone propionate 100
Fluticasone 100 is a HFA pMDI that delivers 50ug of Fluticasone propionate per actuation. Patients will take 2 actuations BID for 12 weeks.
3
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.
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 100 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.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Prior steroid use: steroid-requiring or steroid-free
* 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.
Exclusion 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.
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
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
Research Site
New Braunfels, Texas, United States
Research Site
Waco, Texas, United States
Research Site
South Burlington, Vermont, United States
Research Site
Greenfield, Wisconsin, United States
Research Site
Kelowna, British Columbia, Canada
Research Site
Vancouver, British Columbia, Canada
Research Site
Hamilton, Ontario, Canada
Research Center
London, Ontario, Canada
Research Site
London, Ontario, Canada
Research Site
Mississauga, Ontario, Canada
Research Site
Oshawa, Ontario, Canada
Research Site
Toronto, Ontario, Canada
Research Site
Longueuil, Quebec, Canada
Research Site
Montreal, Quebec, Canada
Research Site
Saint Foy, Quebec, Canada
Research Site
Trois-Rivières, Quebec, Canada
Countries
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References
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Pearlman DS, LaForce CF, Kaiser K. Fluticasone/Formoterol combination therapy compared with monotherapy in adolescent and adult patients with mild to moderate asthma. Clin Ther. 2013 Jul;35(7):950-66. doi: 10.1016/j.clinthera.2013.05.012.
Other Identifiers
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SKY2028-3-002
Identifier Type: -
Identifier Source: org_study_id
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