Efficacy and optimal dosing interval of the long-acting beta2 agonist, vilanterol, in persistent asthma: A randomised trial

Sterling, Richard K.; Lim, Jessica; Frith, Lucy; Snowise, Neil G; Jacques, Loretta; Haumann, Brett

doi:10.1016/j.rmed.2012.03.007

Cited by 29 publications

(23 citation statements)

References 7 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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“…Furthermore, fluticasone furoate 200 lg once daily was non-inferior to a 100 lg twice daily dosage on day 28 in improving trough FEV 1 [21] and there was no significant difference between vilanterol 12.5 lg once daily and 6.25 lg twice daily groups in 0-24 h weighted mean (wm) FEV 1 on day 7 [18], suggesting that both drugs are suitable for once-daily administration. Thus, a combination of fluticasone furoate 100 or 200 lg plus vilanterol 25 lg once daily was selected for further evaluation.…”

Section: Pulmonary and Bronchoprotective Effectsmentioning

confidence: 91%

“…Results from dose-ranging trials showed that fluticasone furoate 100 or 200 lg and vilanterol 25 lg provided an optimal balance between therapeutic effect [improvement over baseline in pre-dose evening (trough) FEV 1 ] and tolerability in patients with various levels of asthma severity [14,[17][18][19][20]. Furthermore, fluticasone furoate 200 lg once daily was non-inferior to a 100 lg twice daily dosage on day 28 in improving trough FEV 1 [21] and there was no significant difference between vilanterol 12.5 lg once daily and 6.25 lg twice daily groups in 0-24 h weighted mean (wm) FEV 1 on day 7 [18], suggesting that both drugs are suitable for once-daily administration.…”

Section: Pulmonary and Bronchoprotective Effectsmentioning

confidence: 99%

Fluticasone Furoate/Vilanterol: a Review of Its Use in Patients with Asthma

Syed

2015

Drugs

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Fluticasone furoate/vilanterol (Relvar(®)) is a once-daily, fixed combination of an inhaled corticosteroid (ICS) and a long-acting β2-adrenoreceptor agonist (LABA), delivered via a dry powder inhaler (Ellipta(®)). It is approved for the treatment of asthma in the EU and Japan, and is the first once-daily ICS/LABA to be available for this indication. Fluticasone furoate is an enhanced-affinity glucocorticoid receptor agonist, with potent anti-inflammatory activity. Vilanterol produces rapid and prolonged bronchodilation. In phase III trials in adolescents and adults with various levels of asthma uncontrolled on ICS and/or ICS/LABA, fluticasone furoate/vilanterol 100/25 or 200/25 µg once daily (approved dosages in the EU) significantly improved pulmonary function compared with placebo or equivalent dosages of fluticasone furoate alone (in some trials) or fluticasone propionate. In similar trials, fluticasone furoate/vilanterol 100/25 µg once daily was as effective as fluticasone propionate/salmeterol 250/50 µg twice daily in improving pulmonary function and significantly reduced the risk of severe asthma exacerbation relative to fluticasone furoate alone. In clinical trials, fluticasone furoate/vilanterol was generally well tolerated with fewer than 15 % of patients experiencing treatment-related adverse events, the most common of which were oral/oropharyngeal candidiasis, dysphonia, extrasystoles and cough. The tolerability profile of fluticasone furoate/vilanterol was generally similar to that of fluticasone propionate/salmeterol. Thus, fluticasone furoate/vilanterol is an effective and generally well tolerated ICS/LABA option for the treatment of uncontrolled asthma.

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“…VI is well tolerated with minimal adverse events indicative of LABA-class effects such as tremor, muscle twitching, and palpitations in doses up to 100 µg [37,45,46].…”

Section: Safety and Tolerabilitymentioning

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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Efficacy and optimal dosing interval of the long-acting beta2 agonist, vilanterol, in persistent asthma: A randomised trial

Cited by 29 publications

References 7 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

Fluticasone Furoate/Vilanterol: a Review of Its Use in Patients with Asthma

Phamacology of fluticasone furoate and vilanterol trifenatate combination therapy for asthma

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