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Chronic inflammation is the key pathophysiological mechanism in the development of COPD and there is increasing interest in the potential role of novel anti-inflammatory treatments. This phase III multicentre double blind study focuses on roflumilast, an oral phosphodiesterase 4 inhibitor.
1411 patients with stable moderate to severe COPD were randomised to receive placebo, roflumilast 250 μg once daily, or roflumilast 500 μg once daily for 24 weeks. The primary outcome measures were post-bronchodilator forced expiratory volume in 1 second (FEV1) and St George’s Respiratory Questionnaire (SGRQ) total score. Secondary outcome measures included the number of COPD exacerbations. The results showed a mean (SD) improvement in FEV1 of 74 (18) ml with roflumilast 250 μg and 97 (18) ml with roflumilast 500 μg compared with placebo at 24 weeks (p<0.0001). There were no significant differences in the SGRQ scores between the roflumilast and placebo groups. The mean number of exacerbations was reduced by 34% in the roflumilast 500 μg group compared with the placebo group, primarily due to a reduction in mild exacerbations (42%, p = 0.004). Adverse effects were predominantly gastrointestinal in nature and self-limiting.
This study provides encouraging initial data to support the use of roflumilast in patients with COPD. Further studies are needed to confirm that these results are sustained beyond 24 weeks and to assess further the effects on health-related quality of life.
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