Relvar Ellipta: combination inhaler for asthma and COPD

Relvar Ellipta (vilanterol/fluticasone furoate) is a new fixed-dose combination inhaler for asthma and COPD.

In asthma patients fluticasone furoate 100 microgram once daily is approximately equivalent to fluticasone propionate 250 microgram twice daily.
In asthma patients fluticasone furoate 100 microgram once daily is approximately equivalent to fluticasone propionate 250 microgram twice daily.

The dry powder inhaler is indicated for regular treatment of asthma where a long-acting ß2-agonist (LABA) and an inhaled corticosteroid is appropriate. It is also indicated for the symptomatic treatment of COPD in patients with a post-bronchodilator FEV1 <70% predicted and a history of exacerbations despite regular bronchodilator therapy.

PHARMACOLOGY

Relvar Ellipta contains vilanterol, a selective LABA with bronchodilator activity and fluticasone furoate, a synthetic trifluorinated corticosteroid with potent anti-inflammatory activity.1

Relvar Ellipta is given as one puff once daily. The dose should be titrated to the lowest effective fluticasone dose in the treatment of asthma. In COPD, only the lower strength inhaler (22 microgram/92 microgram) is licensed for use.1

When prescribing to patients with asthma, prescribers should be aware that fluticasone furoate 100 microgram once daily is approximately equivalent to fluticasone propionate 250 microgram twice daily.1

CLINICAL STUDIES

Asthma

The efficacy of a vilanterol/fluticasone furoate dry powder inhaler was compared with that of a sameterol/fluticasone propionate dry powder inhaler in a 24-week double-blind phase III study involving 806 asthma patients with an inadequate response to medium-dose inhaled corticosteroid therapy.2

Patients were randomised to receive 22 microgram vilanterol/92 microgram fluticasone furoate once daily or 50 microgram salmeterol/250 microgram fluticasione propionate twice daily.2

An improvement in 0- to 24-hour serial weighted mean (wm) FEV1 from baseline to end of treatment was observed with both vilanterol/fluticasone (341mls) and salmeterol/fluticasone (377mls). The mean treatment difference was not statistically significant (-37ml; 95% CI -88 to 15ml, p=0.162).2

Increased FEV1

Improvements in 0- to 4-hour wm FEV1, trough FEV1 and asthma control and quality of life questionnaire scores were also observed, with no significant differences between the two treatments.2 

COPD

Approval of Relvar Ellipta for use in COPD was based on the results of a 12-week randomised, double-blind study comparing once-daily vilanterol/fluticasone furoate administered via the Ellipta dry powder inhaler (n=266) with twice-daily salmeterol/fluticasone propionate administered via Accuhaler (n=262) in patients with moderate to very severe COPD.3

The change from baseline in 0- to 24-hour wm FEV1 (primary endpoint) was greater with 22 microgram vilanterol/92 microgram fluticasone furoate than with 50 microgram salmeterol/500 microgram fluticasione propionate (130ml vs 108ml) although the difference was not significant (p=0.282).3 

Median time to ≥100ml improvement in FEV1 on day 1 was shorter in the vilanterol/fluticasone group than in the salmeterol/fluticasone group (16 vs 28 minutes) but again the difference was not significant.3

Quality of life

The study also evaluated the effect of treatment on quality of life using the St George’s Respiratory Questionnaire (SGRQ). Statistically significant differences in SGRQ score were not observed, although total score improved from baseline for both vilanterol/fluticasone and salmeterol/fluticasone.3

Safety profile

No apparent differences in the safety profiles of vilanterol/fluticasone and salmeterol/fluticasone were observed in either study.2,3


References:

  1. Relvar Ellipta Summary of Product Characteristics, November 2013.
  2. Woodcock A et al. Chest 2013;144:1222-29.
  3. Agusti A et al. Eur Respir J 2013;doi:10.1183/09031936.00054213.

View Relvar Ellipta drug record

Further information: GlaxoSmithKline

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