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Human medicines European public assessment report (EPAR): Incruse Ellipta (previously Incruse), umeclidinium bromide, Date of authorisation: 28/04/2014, Revision: 19, Status: Authorised

Incruse Ellipta was investigated in four main studies involving over 4,000 patients. Three studies compared Incruse Ellipta with placebo (a dummy treatment), while one study compared Incruse Ellipta with tiotropium (another medicine for COPD). 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 Incruse Ellipta improved lung function by an average FEV1 of 127 ml more than placebo after 12 weeks of treatment and by 115 ml more than placebo after 24 weeks of treatment. A double dose of Incruse Ellipta only showed small improvements compared with a single dose, which were not considered relevant. In the study comparing Incruse Ellipta with tiotropium, FEV1 improvements over 24 weeks were similar for both medicines.

The studies also showed an improvement in symptoms such as breathlessness and wheezing.

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