Table 2.

Long-term studies involving roflumilast

Study	Duration	Treatment	Baseline mean postbronchodilator FEV1%pred	Sample	Primary endpoint
The RECORD (M2-107)	24 weeks	Roflumilast 250 μg, roflumilast 500 μg, placebo	54	N = 1411	Change from baseline in postbronchodilator FEV1 Change from baseline in HRQoL scores (SGRQ)
The OPUS (M-111) and The RATIO (M-112)	52 weeks	Roflumilast 500 μg once daily or placebo	37	N = 2686 (post-hoc analysis sample)	Change from baseline in and postbronchodilator FEV1 exacerbation rate
The EOS (M 2-127)	24 weeks	Roflumilast 500 μg + salmeterol once daily or placebo + salmeterol	55%	N = 933	Change from baseline in prebronchodilator FEV1
The HELIOS (M 2-128)	24 weeks	Roflumilast 500 μg once daily + tiotropium or placebo + tiotropium	55%	N = 743	Change from baseline in prebronchodilator FEV1
The AURA (M-124)	52 weeks	Roflumilast 250 μg, roflumilast 500 μg, placebo	<50%	N = 1523	Change in prebronchodilator FEV1 from baseline The rate of moderate and severe exacerbations
The HERMES (M-125)	52 weeks	Roflumilast 250 μg, roflumilast 500 μg, placebo	<50%	N = 1568	Change in prebronchodilator FEV1 from baseline The rate of moderate and severe exacerbations

Abbreviations: HRQoL, health-related quality of life; SGRQ, St. George’s Respiratory Questionnaire.