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

Luo, Jian; Wang, Ke; Liu, Dan; Liang, Bin-Miao; Liu, Chun-Tao

doi:10.1186/s12931-016-0330-y

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	Outcomes^a
Author (Year)		NCT No.	Patients	Population (I/C)	Drug	Dose	Frequency	Control	Routine	Duration	Follow-up	Outcomes^a
Bredenbroker, 2002 [16]		FK1 101	Mild to severe COPD	341 (169/172)	Roflumilast	500ug	Once daily	Placebo	Oral	26 weeks	26 weeks	①
Boszormenyi-Nagy, 2005 [17]		FK1 103	Mild to severe COPD	386 (200/186)	Roflumilast	500ug	Once daily	Roflumilast + Placebo	Oral	24 weeks	24 weeks	①
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	①②③④⑤⑥⑧⑨
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	①②③④⑤⑥⑧⑨
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	①②③⑤⑦⑧⑨
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	①②③⑥⑦⑧⑨
Fabbri, 2009 [13]	M2-128	NCT00424268		743 (371/372)	Roflumilast + Tiotropium	500ug	Once daily	Tiotropium + Placebo	Oral	24 weeks	24 weeks	①②③⑥⑦⑧⑨
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	①②③④⑤⑧⑨

^aOutcome measures include: ① Change of prebronchodilator FEV₁; ② Change of postbronchodilator FEV₁; ③ Change of postbronchodilator FVC; ④ Change of postbronchodilator FEV₆; ⑤ Change of postbronchodilator FEF_25-75; ⑥ Change of SGRQ; ⑦ Change of TDI; ⑧ Incidence of exacerbation; ⑨ Incidence of adverse events
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

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ISSN: 1465-993X

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