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024). The SGRQ total score deteriorated similarly in both treatment arms (?1.7 and ?2.0 units, respectively), but the retrospective analysis by GOLD stage showed that RO4929097 research buy subjects with very severe disease (GOLD stage IV) improved with roflumilast by 2.97 units compared with placebo (P?=?0.086). To further expand on the findings related to exacerbations in patients with severe COPD, an identical pair of studies was performed and reported in a single publication by Calverley et?al. (9). The enrolled patients had severe COPD (mean post-bronchodilator FEV1, 36% of predicted), chronic cough and sputum production, and at least one COPD exacerbation within the previous year, findings predictive of a higher exacerbation rate in post hoc analysis of the earlier studies. Long-acting bronchodilators were allowed, Fleroxacin but inhaled corticosteroids were withheld throughout the study period. Patients were assigned to treatment, stratified according to smoking status and treatment with long-acting ��2-agonists, with oral roflumilast 500??g once daily (n?=?1537) or placebo (n?=?1554) for 52 weeks. The co-primary end points were change in pre-bronchodilator FEV1 and the rate of moderate to severe exacerbations. The secondary outcome variables included post-bronchodilator FEV1 and transition dyspnoea index (TDI) focal score. In both studies, patient withdrawal was similar in the roflumilast and placebo groups (35% and 31%, respectively, and 32% and 31%, respectively) at the study end point, but more patients in the roflumilast groups than in the placebo groups withdrew in the first 12 weeks after randomisation. In both studies, the pre-specified primary end points were achieved and were similar in magnitude. The pre-bronchodilator FEV1 increased, in the pooled analysis, by 48?mL with roflumilast compared with placebo (P?selleck products rate of moderate or severe exacerbations per patient per year was 1.14 with roflumilast and 1.37 with placebo (reduction, 17%; P?