Change in FEV1 Definition | Authors | Study Name | Geographic location | Follow-up (mths) | Patient N | Female (%) | Mean Age Years (SD) | Intervention (dose μg) | Change in FEV1 in ml (SD or 95%CI) |
---|---|---|---|---|---|---|---|---|---|
Mean change in FEV1 (ml) | Auffarth et al 1991 [21] | – | Netherlands | 3 | 24 | 0.04 | 57.0 (8.2) | Placebo | -120 (230) |
 | Bud (1600) | 15 (110) | |||||||
Cazzola et al 2000 [22] | – | Italy | 3 | 80 | 11.6 | 64.2 (6.3) | Sal (50) | 163 (80 to 245) | |
Sal/FP (50/250) | 188 (89 to 287) | ||||||||
Sal/FP (50/500) | 239 (183 to 296) | ||||||||
Lee et al 2016 [23] | – | China, Hong Kong, Indonesia, South Korea, Thailand | 3 | 577 | 4.3 | 66.8 (8.3) | Tio (18) | 80 (27) | |
Tio + bud/form (18 + 160/4.5) | 160 (29) | ||||||||
Bourbeau et al 1998 [24] | – | Canada | 6 | 79 | 21.5 | 66.0 (8.0) | Placebo | 0–3 months: −1(−65 to 62) 0–6 months:12(− 61 to 85) | |
Bud (400) | 0–3 months: −13(−59 to 33) 0–6 months:8(−51 to 68) | ||||||||
Ohar et al 2014 [25] | – | United States, Argentina, Norway | 6.5 | 639 | 46 | 62.9 (9.2) | Sal (50) | 40 (342) | |
FP/Sal (250/50) | 140 (372) | ||||||||
Vestbo et al 2005 [26] | TRISTAN | Australia, Austria, Belgium, Canada, Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Iceland, Italy, Lithuania, Netherlands, New Zealand, Norway, Poland, Russia, South Africa, Spain, Sweden, Switzerland, IK | 12 | 1465 | 27.6 | 63.2 (8.6) | Placebo | −65 (−200 to 85) | |
Sal (50) | 0 (− 130 to 140) | ||||||||
FP (500) | 0 (−160 to 160) | ||||||||
Sal/FP (50/500) | 80 (−50 to 250) | ||||||||
Rate of FEV1 change (ml/year) | Vestbo et al 2017 [27] | TRINITY | Argentina, Belarus, Bulgaria, Croatia, Germany, Hungary, Italy, Mexico, Poland, Romania, Russia, Slovakia, Turkey, UK, Ukraine | 12 | 2691 | 23.6 | 63.2 (8.6) | Tio (18) | 21 (3 to 39) |
Fixed: Beclo/FP/gly bro (100/6/12.5) | 82 (65 to 100) | ||||||||
Open: Becl/FP/Tio (100/6/18) | 85 (31 to 110) | ||||||||
Wise et al 2000 [28] | Lung Health Study | North America, Canada | 12 | 1116 | 36.9 | 56.3 (6.8) | Placebo | −47 (70.8) | |
Triamcinolone acetonide (600) | −44.2 (69.8) | ||||||||
Weir et al 1999 [29] | – | UK | 24 | 98 | 25.5 | 66.6 (7.0) | Placebo | −56.9 (15) | |
 |  |  |  | Becl (750) | −20.6 (16) | ||||
Renkema et al 1996 [30] | – | Netherlands | 24 | 59 | 0 | 56.0 (8.6) | Placebo | −60 (− 570 to 140) | |
Bud (800) | −30 (−180 to 870) | ||||||||
Bud + oral prednisolone (800/5) | −40 (−340 to 60) | ||||||||
Burge PS et al 2000 [31] | ISOLDE | UK | 36 | 751 | 25.4 | 63.7 (7.1) | Placebo | −59 (30.8) | |
FP (500) | −50 (28.7) | ||||||||
Calverley PM et al 2003 [32] | ISOLDE | UK | 36 | 751 | 25.3 | 63.7 (7.1) | Placebo | −46 | |
FP (500) | −51 | ||||||||
Pauwels et al 1999 [33] | – | Belgium, Denmark, Finland, Italy, Netherlands, Norway, Spain, Sweden, UK | 36 | 1277 | 27.2 | 52.5 (7.6) | Placebo | 0–6 months: −81 9–36 months: −69 | |
 | Bud (400) | 0–6 months: 17 9–36 months: −57 | |||||||
Vestbo 1999 [34] | CCHS | Denmark | 36 | 290 | 39.7 | 59.1 (9) | Placebo | −49.1 | |
 | Bud (400) | −46.0 | |||||||
SUMMIT | US, Argentina, Australia, Austria, Belarus, Belgium, Bosnia & Herzegovina, Bulgaria, Canada, Chile, China, Columbia, Croatia, Czech Republic, France, Georgia, Germany, Greece, Hungary, India, Indonesia, Israel, Italy, Japan, Korea, Latvia, Malaysia, Macedonia, Mexico, Netherlands, Philippines, Poland, Romania, Russia, Serbia, Slovakia, South Africa, Spain, Taiwan, Thailand, Turkey Ukraine, UK, Vietnam | 48 | 16,485 | 25.5 | 65.0 (8.0) | Placebo | −46 (160.3) | ||
Vil (25) | −47 (154.0) | ||||||||
FF (100) | −38 (154.3) | ||||||||
FF/Vil (100/25) | −38 (154.1) | ||||||||
Shaker et al 2009 [36] | – | Denmark | 48 | 254 | 42 | 63.6 (7.4) | Placebo | −56 (−72 to −40) | |
 |  | Bud (400) | −54 (−69 to-40) |