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Table 2 Details of each enrolled study

From: Can roflumilast, a phosphodiesterase-4 inhibitor, improve clinical outcomes in patients with moderate-to-severe chronic obstructive pulmonary disease? A meta-analysis

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
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
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
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
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
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)
  1. aOutcome measures include: Change of prebronchodilator FEV1; Change of postbronchodilator FEV1; Change of postbronchodilator FVC; Change of postbronchodilator FEV6; Change of postbronchodilator FEF25-75; Change of SGRQ; Change of TDI; Incidence of exacerbation; Incidence of adverse events
  2. COPD chronic obstructive pulmonary disease, FEF 25-75 forced expiratory flow between 25 and 75 % of the vital capacity, FEV 1 forced expiratory volume in one second, FEV 6 forced expiratory volume in six seconds, FVC forced vital capacity, I/C intervention/control, NM not mentioned, No. numbers, SGRQ St George’s Respiratory Questionnaire, TDI transition dyspnea index