Dose effect of once-daily fluticasone furoate in persistent asthma: A randomized trial

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

doi:10.1016/j.rmed.2012.01.004

Cited by 66 publications

(65 citation statements)

References 28 publications

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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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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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“…This was demonstrated in a study of moderate asthmatics [41]. Several studies have demonstrated the efficacy and safety of this drug in asthma patients in dosages of 50 --400 µg daily [42][43][44][45]. However, a randomized controlled trial investigating the efficacy of a small dose of 50 µg once daily in mild to moderate asthmatics did not show a significant change in the primary endpoint (FEV1) compared with placebo after 24 weeks of treatment [46].…”

Section: Market Reviewmentioning

confidence: 98%

Emerging corticosteroid agonists for the treatment of asthma

Westergaard¹,

Porsbjerg

Backer³

2015

Expert Opinion on Emerging Drugs

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Compared with drugs acting on other pathological pathways, research in GRAs for asthma is sparse. However, a few promising agents acting selectively on the GR are currently under investigation and may reach approval for asthma treatment. These drugs exhibit improved pharmacodynamic properties due to selectivity in the mechanism of action, including promotion of transrepression and reduction of transactivation. However, competition from already approved ICS and other emerging treatment options may lead to cessation of development of the new GRAs.

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“…Doses of FF between 25 and 200 µg OD and FP 100 µg BD and placebo were compared for 8 weeks in patients with persistent asthma [31]. Doses of FF greater than 50 µg OD significantly increased the FEV 1 compared with placebo, with doses of 100 and 200 µg increasing the FEV 1 by greater than 200 mL.…”

Section: Phase I and Ii Efficacy Studiesmentioning

confidence: 99%

Phamacology of fluticasone furoate and vilanterol trifenatate combination therapy for asthma

Chang

Gray

Thomas

2016

Expert Review of Respiratory Medicine

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FF has a highly specific, fast association and slow dissociation from the glucocorticoid receptor, with a 24 hr duration of action. This, combined with a slow transport out of respiratory cells, creates a long tissue retention period. Vilanterol trifenate (VI) is a new inhaled, selective, long - acting β2 adrenergic agonist, also with a rapid onset of action with a maximal effect within 6 mins and prolonged lung retention with effects on lung function over 24 hours. Expert commentary: Multiple Phase I-III efficacy studies performed on FF and VI have shown an improvement in spirometry as well as symptom control in asthma. The development of once daily ICS/LABA combinations may potentially improve adherence to asthma therapy, but this has yet to be demonstrated.

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Dose effect of once-daily fluticasone furoate in persistent asthma: A randomized trial

Abstract: FF 50-200 μg/day once daily in the evening demonstrated dose-related efficacy in asthma with 100-200 μg appearing to be the optimal doses for further evaluation. ClinicalTrials.gov: NCT00603382.

Cited by 66 publications

References 28 publications

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

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

Emerging corticosteroid agonists for the treatment of asthma

Phamacology of fluticasone furoate and vilanterol trifenatate combination therapy for asthma

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