New Combination Inhaler (FlutiForm HFA MDI 100/10 µg and 250/10 µg) in Patients With Asthma
NCT ID: NCT00394121
Last Updated: 2010-08-27
Study Results
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Basic Information
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COMPLETED
PHASE3
400 participants
INTERVENTIONAL
2006-03-31
2007-07-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
PARALLEL
TREATMENT
NONE
Interventions
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Fluticasone propionate/formoterol fumarate
Eligibility Criteria
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Inclusion Criteria
* Documented use of inhaled corticosteriod 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 6 months of Screening Visit or at Screening Visit (15% increase from pre-FEV-1 levels following albuterol inhalation).
* 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 the past 6 months.
* History of leukotriene receptor antagonist use, e.g., montelukast, within the past week.
* Current evidence of 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.
12 Years
ALL
No
Sponsors
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SkyePharma AG
INDUSTRY
Locations
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Research Site
Berlin, , Germany
Research Site
Hamburg, , Germany
Research Site
Mainz, , Germany
Research Site
Rudersdorf, , Germany
Research Site
Solingen, , Germany
Research Site
Budapest, , Hungary
Research Site
Deszk, , Hungary
Research Site
Kecskemét, , Hungary
Research Site
Miskolc, , Hungary
Research Site
Mosonmagyaróvár, , Hungary
Research Site
Bialystok, , Poland
Research Site
Gdansk, , Poland
Research Site
Krakow, , Poland
Research Site
Lodz, , Poland
Research Site
Wroclaw, , Poland
Research Site
Bucharest, , Romania
Research Site
Birmingham, , United Kingdom
Research Site
Carrickfergus, , United Kingdom
Research Site
Chippenham, , United Kingdom
Research Site
Cottingham, , United Kingdom
Research Site
Coventry, , United Kingdom
Research Site
Downpatrick, , United Kingdom
Research Site
Heywood, , United Kingdom
Research Site
Manchester, , United Kingdom
Research Site
Sheffield, , United Kingdom
Research Site
Solihull, , United Kingdom
Research Site
Sunbury-on-Thames, , United Kingdom
Research Site
Swindon Wilts, , United Kingdom
Countries
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References
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Mansur AH, Kaiser K. Long-term safety and efficacy of fluticasone/formoterol combination therapy in asthma. J Aerosol Med Pulm Drug Deliv. 2013 Aug;26(4):190-9. doi: 10.1089/jamp.2012.0977. Epub 2012 Oct 25.
Other Identifiers
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SKY2028-3-003
Identifier Type: -
Identifier Source: org_study_id
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