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Fluticasone furoate...
Fluticasone furoate demonstrates efficacy in patients with asthma symptomatic on medium doses of inhaled corticosteroid therapy: an 8-week, randomised, placebo-controlled trial
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Busse, WW (författare)
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Bleecker, ER (författare)
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Bateman, ED (författare)
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- Lötvall, Jan, 1956 (författare)
- Gothenburg University,Göteborgs universitet,Krefting Research Centre
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Forth, R (författare)
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Davis, AM (författare)
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Jacques, L (författare)
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Haumann, B (författare)
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Woodcock, A (författare)
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(creator_code:org_t)
- 2011-08-09
- 2012
- Engelska.
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Ingår i: Thorax. - : BMJ. - 0040-6376 .- 1468-3296. ; 67:1, s. 35-41
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https://thorax.bmj.c...
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https://gup.ub.gu.se...
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https://doi.org/10.1...
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Abstract
Ämnesord
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- Abstract Background Fluticasone furoate (FF) is a novel inhaled corticosteroid with 24 h activity. FF is being developed as a once-daily treatment in combination with the long-acting β(2) agonist vilanterol trifenatate for asthma and chronic obstructive pulmonary disease. Objectives To determine the optimal dose(s) of FF for treating patients with asthma. Methods An 8-week multicentre, randomised, double-blind study. 627 patients with persistent moderate-to-severe asthma, symptomatic on medium-dose inhaled corticosteroid therapy, were randomised to placebo, FF 200, 400, 600 or 800 μg (once daily in the evening using a novel dry powder inhaler), or fluticasone propionate 500 μg twice daily (via Diskus™/Accuhaler™). The primary efficacy measure was mean change from baseline in pre-dose evening forced expiratory volume in one second (FEV(1)). Other endpoints included morning and evening peak expiratory flow, and rescue/symptom-free 24 h periods. Results Each dose was significantly superior to placebo for the primary endpoint (p<0.001) with efficacy at least similar to that reported with fluticasone propionate. There was no dose-response relationship across the FF doses studied. Peak expiratory flow improved in all groups (p<0.001 vs placebo), and there were significant treatment effects on rescue/symptom-free 24 h periods with all active treatments. FF was generally well tolerated. The incidence of oral candidiasis was higher with FF 800 μg than placebo; pharmacokinetic and 24 h urinary cortisol analyses confirmed a higher systemic exposure of FF at this highest dose level. Conclusions FF doses <800 μg have a favourable therapeutic index. The absence of an efficacy dose response suggests that 200 μg is an appropriate dose in patients with moderate persistent asthma. ClinicalTrials.gov identifier NCT00603746
Ämnesord
- MEDICIN OCH HÄLSOVETENSKAP -- Medicinska och farmaceutiska grundvetenskaper -- Immunologi inom det medicinska området (hsv//swe)
- MEDICAL AND HEALTH SCIENCES -- Basic Medicine -- Immunology in the medical area (hsv//eng)
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Thorax
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Busse, WW
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Bleecker, ER
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Bateman, ED
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Lötvall, Jan, 19 ...
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Forth, R
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Davis, AM
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visa fler...
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Jacques, L
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Haumann, B
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Woodcock, A
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visa färre...
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- MEDICIN OCH HÄLSOVETENSKAP
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Thorax
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Göteborgs universitet