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Human medicines European public assessment report (EPAR): Laventair Ellipta (previously Laventair), umeclidinium bromide,vilanterol, Date of authorisation: 08/05/2014, Revision: 18, Status: Authorised

Laventair Ellipta and a higher-dose combination of umeclidinium bromide and vilanterol were compared with placebo (a dummy treatment), vilanterol alone, umeclidinium bromide alone and another COPD medicine called tiotropium in 4 main studies.

In all 4 studies, involving over 4,700 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 Laventair Ellipta improved lung function by an average FEV1 of 167 ml more than placebo after 24 weeks of treatment. Laventair Ellipta also increased FEV1 by an average of 95 ml more than vilanterol alone and by 52 ml more than umeclidinium bromide alone. The average increase in FEV1 with Laventair Ellipta was 90 ml more than with tiotropium after 24 weeks of treatment.

Laventair Ellipta was also shown to improve symptoms such as breathlessness and wheezing.

The results for the higher dose combination of umeclidinium bromide and vilanterol did not consistently show relevant improvements in lung function to justify its use.

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