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Human medicines European public assessment report (EPAR): Daxas, roflumilast, Date of authorisation: 05/07/2010, Revision: 20, Status: Authorised

Daxas 500 micrograms was shown to be more effective than placebo (a dummy treatment) at treating COPD in two main studies. These involved over 3,000 adults with severe COPD who had had at least one flare-up of their disease in the past year. The patients could continue to receive treatment with a bronchodilator during the study. The main measure of effectiveness was the improvement in forced expiratory volumes (FEV1) and the reduction in the number of moderate or severe flare-ups of their COPD over a year of treatment. FEV1 is the most air a person can breathe out in one second.

At the beginning of the studies, both groups of patients had an FEV1 of around 1 litre (1,000 ml). After a year, the patients who took Daxas had an average increase of 40 ml while those given placebo had an average decrease of 9 ml. In addition, the patients who took Daxas had an average of 1.1 moderate or severe flare-ups of their disease, compared with 1.4 flare-ups in the patients who took placebo.

Another 12-week study involving 1,323 patients examined the effect of starting treatment with Daxas 250 micrograms daily for 4 weeks before increasing the dose to 500 micrograms daily, compared with starting at the higher dose. Around 18% (81 of 441 patients) of those started at 250 micrograms daily dropped out of the study, compared with 25% (109 of 443) of those starting with 500 micrograms daily. Patients started on the lower dose had fewer side effects. The benefits in improving FEV1 were similar in both groups at the end of the study; however, patients who could not take 500 micrograms daily and were then just given 250 micrograms daily did not show an improvement in lung function.