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Draft guidance recommends clinical trial for severe COPD drug
New draft guidance from NICE recommends the use of roflumilast in the context of research, as part of a clinical trial for adults with severe chronic obstructive pulmonary disease (COPD), associated with chronic bronchitis, as an add on to bronchodilator treatment for people with a history of frequent exacerbations.
After carefully considering the evidence, NICE's independent appraisal committee concluded there was great uncertainty about the effect of roflumilast on reducing the rate of exacerbations as an add-on to triple or dual therapy for people with severe COPD. For that reason, the draft guidance recommends setting up a trial to assess its clinical effectiveness for this indication. The draft guidance also recommends that it should be compared with theophylline in people for whom this drug might be suitable.
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