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. 2014 May 12;9:469–479. doi: 10.2147/COPD.S48492

Table 1.

Study characteristics of included trials that provide data on the total number of exacerbations and/or the mean annual rate of exacerbations

Study, year Number of patients Duration of treatment (weeks) Treatment comparisons Baseline characteristics
Reported severity of exacerbations
Quality assessment
Mean age Male % Baseline FEV1 predicted % LTOT excluded Moderate to severe Severe only Concealed allocation ITT analysis Blinding
Mahler et al, 200215 674 24 FP/SAL (500/50 μg bid)
SAL (50 μg bid)
FP (500 μg bid)
PLB bid		 63 66 41 Yes Yes NR Unclear Unclear Yes
Calverley et al, 200316 1,465 52 FP/SAL (500/50 μg bid)
SAL (50 μg bid)
FP (500 μg bid)
PLB bid		 63 73 45 Yes Yes NR Yes Yes Yes
Calverley et al, 200317 1,022 52 BUD/FM (320/9 μg bid)
FM (9 μg bid)
BUD (400 μg bid)
PLB bid		 64 76 36 Yes Yes Yes Unclear Unclear Yes
Hanania et al, 200318 723 24 FP/SAL (250/50 μg bid)
SAL (50 μg bid)
FP (250 μg bid)
PLB bid		 64 63 42 Yes Yes NR Unclear Unclear Yes
Szafranski et al, 200319 812 52 BUD/FM (320/9 μg bid)
FM (9 μg bid)
BUD (400 μg bid)
PLB bid		 64 79 36 Yes Yes NR Yes Yes Yes
SFCT0I study, 200512 387 52 FP/SAL (250/50 μg bid)
SAL (50 μg bid)
FP (250 μg bid)
PLB bid		 64 80 NR Yes Yes Yes Unclear Unclear Yes
Calverley et al, 20075 6,112 156 FP/SAL (500/50 μg bid)
SAL (50 μg bid)
FP (500 μg bid)
PLB bid		 65 76 44 Yes Yes Yes Yes Yes Yes
Kardos et al, 200720 994 44 FP/SAL (500/50 μg bid)
SAL (50 μg bid)		 64 76 40 Yes Yes Yes Yes Yes Yes
Zheng et al, 200721 445 24 FP/SAL (500/50 μg bid)
PLB bid		 66 89 47 Yes† Yes Yes Unclear Unclear Yes
Ferguson et al, 200822 776 52 FP/SAL (250/50 μg bid)
SAL (50 μg bid)		 65 55 33 No Yes NR Yes Unclear Yes
Tashkin et al, 200823 1,417 24 BUD/FM (160–320/9 μg bid)
FM (9 μg bid)
BUD (320 μg bid)
PLB bid		 63 69 40 No Yes Yes Unclear Yes Yes
Anzueto et al, 200924 778 52 FP/SAL (250/50 μg bid)
SAL (50 μg bid)		 65 54 34 No Yes NR Unclear Unclear Yes
Rennard et al, 200925 1,964 52 BUD/FM (160–320/9 μg bid)
FM (9 μg bid)
PLB bid		 63 64 40 No Yes NR Unclear Yes Yes
Calverley et al, 201026 718 48 BDP/FM (400–800/24 μg bid)
FM 24 bid		 64 81 42 Yes Yes Yes Yes Yes Yes
SUMIRE study, 201113 1,293 12 BUD/FM (320/9 μg bid)
FM (9 μg bid)		 65 89 36 No Yes Yes Unclear Unclear Yes
Sharafkhaneh et al, 201227 851 52 BUD/FM (160–320/9 μg bid)
FM (9 μg bid)		 63 62 38 No Yes Yes Yes Unclear Yes
Tashkin et al, 201228 2,251 26 MF/FM (200–400/10 μg bid)
MF (400 μg bid)
FM (10 μg bid)
PLB bid		 60 76 39 Yes Yes Yes Yes Unclear Yes
Zhong et al, 201229 308 24 BUD/FM (160/4.5 μg bid)
BUD (200 μg bid)		 65 95 33 No Yes NR Unclear Yes Yes
Dransfield et al, 201314 1,624 52 FF/VI (100/25 μg qd)
VI (25 μg qd)		 64 58 45 Yes† Yes Yes Yes Yes Yes
Kerwin et al, 201331 1,030 24 FF/VI (100–200/25 μg qd)
FF (100)
VI (25 μg qd)
PLB qd		 63 67 43 Yes Yes Yes Yes Yes Yes
Martinez et al, 201330 1,224 24 FF/VI (100–200/25 μg qd)
FF (100–200 μg qd)
VI (25 μg qd)
PLB qd		 62 72 44 Yes Yes Yes Yes Yes Yes

Notes: Postbronchodilator;

†

less than 12 hours LTOT was allowed.

Abbreviations: BDP, beclomethasone dipropionate; bid, twice a day; BUD, budesonide; FEV1, forced expiratory volume in I second; FF, fluticasone furoate; FM, formoterol; FP, fluticasone propionate; ITT, intention to treat; LTOT, long-term oxygen therapy; MF, mometasone furoate; NR, not reported; PLB, placebo; qd, once a day; SAL, salmeterol; VI, vilanterol.