Table 2 Details of each enrolled study
Author (Year) | NCT No. | Patients | Population (I/C) | Intervention | Control | Routine | Duration | Follow-up | Outcomesa | ||
|---|---|---|---|---|---|---|---|---|---|---|---|
Drug | Dose | Frequency | |||||||||
Rennard, 2011 [21] | NCT00076089 (M2-111) | COPD with postbronchodilator FEV1% of 50 % or less, age ≥ 40 years and a smoking history > 10 pack-year | 1173 (567/606) | Roflumilast | 500ug | Once daily | Placebo | Oral | 52 weeks | 52 weeks | ①②⑥⑧⑨ |
Ferguson, 2012 [22] | NCT01443845 | Severe-to-very-severe COPD patients with a history of exacerbations | 2300 (1150/1150) | Roflumilast | 500ug | Once daily | Placebo | Oral | 12 months | 12 months | ⑧ |
O’Donnell, 2012 [23] | M2-118 | COPD with postbronchodilator FEV1% of 30 ~ 80 %, age ≥ 40 years and a smoking history ≥ 10 pack-year | 250 (127/123) | Roflumilast | 500ug | Once daily | Placebo | Oral | 12 weeks | 12 weeks | ①②⑤⑦⑧⑨ |
Zheng, 2014 [24] | NCT01313494 | COPD with postbronchodilator FEV1% of 50 % or less, age ≥ 40 years and a smoking history ≥ 10 pack-year | 626 (313/313) | Roflumilast | 500ug | Once daily | Placebo | Oral | 24 weeks | 24 weeks | ①②③⑦⑧⑨ |
Martinez, 2015 [25] | NCT01329029 (REACT) | COPD with postbronchodilator FEV1% of 50 % or less, age ≥ 40 years and a smoking history ≥ 20 pack-year | 1935 (969/966) | Roflumilast | 500ug | Once daily | Placebo | Oral | 52 weeks | 52 weeks | ②③⑧⑨ |
Wells, 2015 [14] | NCT01572948 | Moderate-to-severe COPD with age > 40 years and a smoking history > 10 pack-year | 27 (11/16) | Roflumilast | 500ug | Once daily | Placebo | Oral | 30 days | 14 weeks (12 weeks for lung function test) | ①②③⑨ |