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Efficacy and safety...
Efficacy and safety of once-daily fluticasone furoate 50 mcg in adults with persistent asthma: a 12-week randomized trial
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O'Byrne, P. M. (author)
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Woodcock, A. (author)
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Bleecker, E. R. (author)
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Bateman, E. D. (author)
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- Lötvall, Jan, 1956 (author)
- Gothenburg University,Göteborgs universitet,Krefting Research Centre
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Forth, R. (author)
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Medley, H. (author)
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Jacques, L. (author)
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Busse, W. W. (author)
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(creator_code:org_t)
- 2014-08-11
- 2014
- English.
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In: Respiratory Research. - : Springer Science and Business Media LLC. - 1465-993X. ; 15
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https://respiratory-...
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https://doi.org/10.1...
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Abstract
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- Background: Fluticasone furoate (FF) is a novel, once-daily inhaled corticosteroid (ICS) that has been shown to improve lung function vs. placebo in asthma patients. This study evaluated the efficacy and safety of FF 50 mcg compared with placebo in asthma patients uncontrolled by non-ICS therapy. Methods: This 12-week, multicentre, randomized, double-blind, placebo-controlled, parallel-group, phase III study randomized 248 patients (aged >= 12 years) to once-daily FF 50 mcg administered via the ELLIPTA (TM)(a) dry powder inhaler or placebo. The primary endpoint was change from baseline in pre-dose evening trough forced expiratory volume in one second (FEV1). Secondary endpoints were change from baseline in percentage of rescue-free 24-h periods (powered), evening and morning peak expiratory flow, symptom-free 24-h periods and withdrawals due to lack of efficacy. Other endpoints included Asthma Control Test (TM), Asthma Quality of Life Questionnaire and ELLIPTA ease of use questions. Safety was assessed throughout the study. Results: There was a significant difference in evening trough FEV1 between FF 50 mcg and placebo (treatment difference: 120 mL; p = 0.012). There was also a significant difference in rescue-free 24-h periods (11.6%; p = 0.004) vs. placebo. There were numerically greater improvements with FF vs. placebo for all remaining secondary endpoints. The incidence of adverse events was lower with FF (31%) than with placebo (38%); few were treatment-related (FF 50 mcg: n = 1, < 1%; placebo: n = 4, 3%). Conclusion: FF 50 mcg once daily significantly improved FEV1 and percentage of rescue-free 24-h periods experienced over 12 weeks vs. placebo, and was well tolerated.
Subject headings
- MEDICIN OCH HÄLSOVETENSKAP -- Klinisk medicin (hsv//swe)
- MEDICAL AND HEALTH SCIENCES -- Clinical Medicine (hsv//eng)
Keyword
- Fluticasone furoate
- Inhaled corticosteroid
- Lung function
- Once daily
- Safety
- PLACEBO-CONTROLLED TRIAL
- PULMONARY-FUNCTION
- FUROATE/VILANTEROL
- PROPIONATE
- Respiratory System
Publication and Content Type
- ref (subject category)
- art (subject category)
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- By the author/editor
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O'Byrne, P. M.
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Woodcock, A.
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Bleecker, E. R.
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Bateman, E. D.
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Lötvall, Jan, 19 ...
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Forth, R.
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show more...
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Medley, H.
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Jacques, L.
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Busse, W. W.
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show less...
- About the subject
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- MEDICAL AND HEALTH SCIENCES
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MEDICAL AND HEAL ...
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and Clinical Medicin ...
- Articles in the publication
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Respiratory Rese ...
- By the university
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University of Gothenburg