Fluticasone furoate demonstrates efficacy in patients with asthma symptomatic on medium doses of inhaled corticosteroid therapy: an 8-week, randomised, placebo-controlled trial

Busse, William W.; Bleecker, Eugene R.; Bateman, Eric D.; Lötvall, Jan; Forth, Richard; Davis, Angela; Jacques, Loretta; Haumann, Brett; Woodcock, Ashley

doi:10.1136/thoraxjnl-2011-200308

Cited by 74 publications

(63 citation statements)

References 19 publications

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“…Furthermore, there was no apparent trend observed for a relationship between higher individual systemic levels of FF and lower individual serum cortisol. FF has been extensively studied at a range of doses in adults with asthma; data from a series of 6-8-week dose-ranging studies showed no significant effect on urinary cortisol at inhaled doses of up to and including 600 mg, 10,11,15,16 and a recent metaanalysis suggests that the daily clinical dose of FF is not inferior to that of fluticasone proprionate, in terms of cortisol suppression. 17 The findings of the present study are strengthened by a number of factors.…”

Section: Discussionmentioning

confidence: 99%

“…In adults with asthma, a formal pharmacokinetic analysis of the 100 mg dose investigated in Phase II studies was not possible due to the low number of quantifiable results, 10 while analysis of the 200 mg dose indicated an AUC of 525 pg h/mL. 11 This higher AUC in adults may suggest a higher systemic exposure of FF. However, a number of factors should be considered in the absence of formal PK comparisons with identical doses.…”

Section: Discussionmentioning

confidence: 99%

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Safety, tolerability, pharmacokinetics, and pharmacodynamics of fluticasone furoate, a novel inhaled corticosteroid, in children aged 5–11 years with persistent asthma: A randomized trial

Oliver

Allen

VanBuren

et al. 2013

Clinical Pharm in Drug Dev

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This multi-center, randomized, double-blind, placebo-controlled, two-way crossover study characterized the safety, tolerability, pharmacokinetics, and pharmacodynamics of fluticasone furoate (FF) in children (5-11 years) with persistent asthma. Twenty-seven children received inhaled FF 100 mg or placebo via the ELLIPTA TM dry powder inhaler once daily for 14 days, with a !7 day washout period. Adverse events (AEs) were reported by eight (31%) and four (16%) subjects during FF 100 mg and placebo treatment, respectively. Headache was reported by three subjects during FF 100 mg treatment and by no subjects during placebo treatment, all other AEs were reported by only one subject on either treatment; there were no serious AEs. Following repeat dosing, the arithmetic mean (SD) FF C max was 26.71 pg/mL (9.16) at 31 minutes post-dose. Arithmetic mean (SD) FF AUC (0-t) was 121.44 pg h/mL (83.04). Arithmetic mean values for weighted mean (SD) serum cortisol (0-12 hours) on day 14 were 56.49 (16.51) and 67.57 (20.66) ng/mL for FF 100 mg and placebo, respectively. No clinically significant effect of FF on serum cortisol levels was observed. FF was well tolerated. Pharmacokinetic profiles were well defined and did not differ between age groups in the study population, and no clinically significant suppression of serum cortisol was observed.

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Section: Discussionmentioning

confidence: 99%

Section: Discussionmentioning

confidence: 99%

Safety, tolerability, pharmacokinetics, and pharmacodynamics of fluticasone furoate, a novel inhaled corticosteroid, in children aged 5–11 years with persistent asthma: A randomized trial

Oliver

Allen

VanBuren

et al. 2013

Clinical Pharm in Drug Dev

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“…Phase IIb dose-ranging trials of VI in COPD [12] and FF in asthma [13][14][15] have shown that both therapies are efficacious and exhibit a once-daily dosing profile [16,17]. FF/VI has been studied at strengths of 50/ 25 mg, 100/25 mg and 200/25 mg in a small 4-week crossover study [18], and in larger 24-week lung function studies [19,20] and 52-week exacerbation studies [21]; none of these studies compared FF/VI with an established ICS/LABA combination, such as FP/SAL.…”

Section: Introductionmentioning

confidence: 99%

A comparison of the efficacy and safety of once-daily fluticasone furoate/vilanterol with twice-daily fluticasone propionate/salmeterol in moderate to very severe COPD

et al. 2013

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Fluticasone furoate/vilanterol trifenatate (FF/VI) is a once-daily inhaled corticosteroid/longacting b 2 -agonist combination in development for chronic obstructive pulmonary disease (COPD) treatment. We compared the efficacy and safety of FF/VI versus fluticasone propionate/salmeterol (FP/SAL) twice daily over 12 weeks.Moderate to very severe COPD patients received FF/VI 100/25 mg once daily in the morning (n5266) or FP/SAL 500/50 mg twice daily (n5262). The primary end-point was a change from baseline in 0-24 h weighted mean forced expiratory volume in 1 s (wmFEV1) at 12 weeks. Additional end-points included time to 100 mL improvement from baseline on day 1 and a change from baseline in St George's Respiratory Questionnaire (SGRQ). Safety was also assessed.wmFEV1 (mean 130 mL) was greater and time to 100 mL improvement shorter (median 16 min) with FF/VI than FP/SAL (weighted mean 108 mL, median 28 min). Health status (SGRQ total score) improved in both groups (FF/VI -4.3 units, FP/SAL -3.0 units). Differences between treatments were not statistically significant. Six patients in the FF/VI (2%) and three in the FP/SAL (1%) arm experienced serious adverse events, none of which were considered to be drug related.Improvements in lung function and health status were not significantly different between FF/VI 100/ 25 mg once daily and FP/SAL 500/50 mg twice daily; there was no apparent difference between the safety profiles of either therapy. @ERSpublications Once-daily fluticasone furoate/vilanterol trifenatate and twice-daily fluticasone propionate/ salmeterol act similarly

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“…В то же время в нескольких исследованиях доказано, что ФФ в суточной дозе до 600 мкг, инга лируемый в вечерние часы, а также в суточных дозах 200 и 400 мкг, назначаемый как утром, так и вечером, не влияли на суточную экскрецию кортизола у боль ных БА [10,11].…”

Section: безопасность комбинации вилантерол / фф у пациентов с баunclassified

Fluticasione furoate / vilanterol combination (Relvar Ellipta®) in bronchial asthma: a review of clinical trials

Чикина¹

2015

Pulʹmonologiâ (Mosk.)

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Ингаляционные глюкокортикостероиды (иГКС) яв ляются наиболее мощными противовоспалительны ми препаратами для лечения персистирующей брон хиальной астмы (БА) любой степени тяжести [1]. При использовании иГКС улучшаются контроль над симптомами БА и легочная функция, снижается час тота обострений [1]. Практически все современные иГКС (флутиказона пропионат (ФП), беклометазон, мометазон, будесонид) назначаются 2 раза в день. Вместе с тем доказано, что при использовании инга лятора 1 раз в сутки повышается комплаенс и улуч шается эффективность терапии [2].Единственным иГКС с возможностью назначе ния 1 раз в сутки сегодня является флутиказона фу роат* (ФФ). Химическая структура ФФ отличается от структуры ФП, благодаря чему ФФ обладает более высоким сродством к ГКС рецепторам и способен дольше, чем ФП, задерживаться в легочной тка ни [3].Преимущества иГКС 12 часового действия (при ем 2 раза в сутки) хорошо изучены, однако о влиянии нового иГКС с 24 часовым действием на легочную функцию, контроль над заболеванием, потребность в препаратах для быстрого купирования симптомов и частоту обострений БА пока известно мало.В данном обзоре литературы представлена инфор мация о клинической эффективности и безопасности комбинации новых ингаляционных лекарственных препаратов для лечения БА -ФФ и вилантерола*. Вилантерол представляет собой новый, длительно действующий β 2 агонист (ДДБА), продолжитель ность действия которого, как и ФФ, составляет 24 ч.ФФ быстро абсорбируется из легких, достигая максимальной концентрации в плазме крови через РезюмеПредставлен обзор литературы о клинической эффективности и безопасности новой комбинации ингаляционного глюкокортикосте роида флутиказона фуроата (ФФ) и длительно действующего β2 агониста вилантерола в лечении бронхиальной астмы (БА). При ком бинированной терапии вилантеролом / ФФ эффективно снижаются риск и частота тяжелых обострений БА, улучшаются легочная функция, качество жизни больных и степень контроля над БА, уменьшаются частота симптомов и потребность в быстродействующих бронхолитических препаратах (БП) для купирования симптомов, повышается число бессимптомных дней и дней без потребности в быстродействующих БП при применении 1 раз в сутки. Одинаковая клиническая эффективность и безопасность комбинации вилан терол / ФФ при утреннем и вечернем назначении позволяет выбрать наиболее удобный для пациента режим терапии, что потенциально может улучшить приверженность лечению. Переносимость комбинированной терапии у пациентов с БА вилантеролом / ФФ достовер но не отличается от плацебо. ФФ в комбинации с вилантеролом выпускается в новом, простом и удобном в использовании ингаляци онном устройстве Эллипта SummaryThis review has summarized clinical trials data on efficacy and safety of new combination of inhaled steroid fluticasione furoate (FF) and long act ing beta 2 agonist vilanterol in patients with bronchial asthma. Treatment with this combination could effectively reduce a risk and frequency of severe asthma exacerbations, improve lung function, quality of life and control of asthma, i...

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Fluticasone furoate demonstrates efficacy in patients with asthma symptomatic on medium doses of inhaled corticosteroid therapy: an 8-week, randomised, placebo-controlled trial

Cited by 74 publications

References 19 publications

Safety, tolerability, pharmacokinetics, and pharmacodynamics of fluticasone furoate, a novel inhaled corticosteroid, in children aged 5–11 years with persistent asthma: A randomized trial

Safety, tolerability, pharmacokinetics, and pharmacodynamics of fluticasone furoate, a novel inhaled corticosteroid, in children aged 5–11 years with persistent asthma: A randomized trial

A comparison of the efficacy and safety of once-daily fluticasone furoate/vilanterol with twice-daily fluticasone propionate/salmeterol in moderate to very severe COPD

Fluticasione furoate / vilanterol combination (Relvar Ellipta®) in bronchial asthma: a review of clinical trials

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