Human medicines European public assessment report (EPAR): Rolufta Ellipta (previously Rolufta), umeclidinium, Date of authorisation: 20/03/2017, Revision: 12, Status: Authorised
Rolufta Ellipta was investigated in four main studies involving over 4,000 patients. Three studies compared Rolufta Ellipta with placebo (a dummy treatment), while one study compared Rolufta 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 Rolufta Ellipta improved lung function by an average FEV1 by 127 ml more than placebo after 12 weeks of treatment and by 115 ml after 24 weeks of treatment. A double dose of Rolufta Ellipta only showed small improvements compared with a single dose, which were not considered relevant. In the study comparing Rolufta 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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