Human medicines European public assessment report (EPAR): Bevespi Aerosphere, glycopyrronium,formoterol fumarate dihydrate, Pulmonary Disease, Chronic Obstructive, Date of authorisation: 18/12/2018, Revision: 6, Status: Authorised
Three main studies in over 5,000 patients with COPD have shown that Bevespi Aerosphere is effective at improving patients’ FEV1 (the maximum volume of air they can breathe out in one second).
In these studies, patients treated with Bevespi Aerosphere for 24 weeks had FEV1 increases of around 135 to 150 ml. Patients who received placebo (a dummy treatment), on the other hand, had increases of up to 8 ml or reductions of up to 20 ml.
The studies also showed that Bevespi Aerosphere improved FEV1 more than the single components in the medicine.
Finally, the studies showed that Bevespi Aerosphere can lead to modest improvements in symptoms such as breathlessness.
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