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Human medicines European public assessment report (EPAR): Anoro Ellipta (previously Anoro), umeclidinium bromide,vilanterol, Date of authorisation: 08/05/2014, Revision: 19, Status: Authorised

Anoro Ellipta and a higher-dose combination of umeclidinium and vilanterol (113 micrograms/22 micrograms) were compared with placebo (a dummy treatment), vilanterol alone, umeclidinium alone or another COPD medicine called tiotropium in 5 main studies.

In all 5 studies, involving over 5,600 patients, the main measure of effectiveness was based on changes in the patients’ forced expiratory volumes (FEV1, the maximum volume of air a person can breathe out in one second).

Results showed that Anoro Ellipta improved lung function by an average FEV1 of 167 ml more than placebo after 24 weeks of treatment. Anoro Ellipta also increased FEV1 by an average of up to 95 ml more than vilanterol alone and by 52 ml more than umeclidinium bromide alone. The average increase in FEV1 with Anoro Ellipta was 60, 90 and 112 ml more than with tiotropium after 24 weeks of treatment in the three studies where Anoro Ellipta was compared with tiotropium.

Anoro Ellipta was also shown to improve breathlessness when compared with placebo.

The higher dose combination of umeclidinium and vilanterol did not consistently lead to better improvements in lung function than Anoro Ellipta to justify its use.

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