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Table 1 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
Bredenbroker, 2002 [16] FK1 101 Mild to severe COPD 341 (169/172) Roflumilast 500ug Once daily Placebo Oral 26 weeks 26 weeks
Boszormenyi-Nagy, 2005 [17] FK1 103 Mild to severe COPD 386 (200/186) Roflumilast 500ug Once daily Roflumilast + Placebo Oral 24 weeks 24 weeks
Rabe, 2005 [11] M2-107 COPD with postbronchodilator FEV1% of 30 ~ 80 %, age ≥ 40 years and a smoking history > 10 pack-year 835 (555/280) Roflumilast 500ug Once daily Placebo Oral 24 weeks 24 weeks
Calverley, 2007 [18] NCT00430729 (M2-112) COPD with postbronchodilator FEV1% of 50 % or less, age ≥ 40 years and a smoking history > 10 pack-year 1513 (760/753) Roflumilast 500ug Once daily Placebo Oral 52 weeks 52 weeks
Calverley, 2009 [19] NM (M2-124, M2-125) COPD with postbronchodilator FEV1% of 50 % or less, age > 40 years and a smoking history ≥ 20 pack-year 3091 (1537/1554) Roflumilast 500ug Once daily Placebo Oral 52 weeks 52 weeks
Fabbri, 2009 [13] M2-127 NCT00313209 COPD with postbronchodilator FEV1% of 40 ~ 70 %, age > 40 years and a smoking history > 10 pack-year 933 (466/467) Roflumilast + Salmeterol 500ug Once daily Salmeterol + Placebo Oral 24 weeks 24 weeks
M2-128 NCT00424268 743 (371/372) Roflumilast + Tiotropium Tiotropium + Placebo
Lee, 2011 [20]   NCT00242320 (M2-119) COPD with postbronchodilator FEV1% of 30 ~ 80 %, age ≥ 40 years and a smoking history > 10 pack-year 410 (203/207) Roflumilast 500ug Once daily Placebo Oral 12 weeks 12 weeks
  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