Characteristics of randomised controlled trials included in the analysis of fractures
| Source | Location | Treatment duration, weeks | COPD criteria†‡ | Drug | Male, % | Mean age, years (SD) | Mean % predicted FEV1 (SD) | Prior ICS use (%) |
| Anzueto SCO100250, 2009w1 w16 | 98 centres in the USA and Canada | 52 | FEV1/FVC <70% | SFC 50/250 μg twice daily | 51 | 65.4 (9.1) | 34 (11.1) | 14 |
| Sal 50 μg twice daily | 57 | 65.3 (8.8) | 33.9 (10.6) | 14 | ||||
| Burge FLTB3054, 2000w2 w17 | 18 UK hospitals | 156 | FEV1/FVC <70% | Flu 500 μg twice daily | 75 | 63.7 (7.1) | 50.3 (14.9) | 51.1 |
| Placebo | 74.2 | 63.8 (7.1) | 50.0 (14.9) | 57.0 | ||||
| Calverley SFCB3024, 2003w3 w18 | 196 centres in 25 countries | 52 | ERS | SFC 50/500 μg twice daily | 75 | 62.7 (8.7) | 44.8 (14.7) | 50 |
| Sal 50 μg twice daily | 70 | 63.2 (8.6) | 44.3 (13.8) | 49 | ||||
| Flu 500 μg twice daily | 70 | 63.5 (8.5) | 45 (13.6) | 54 | ||||
| Placebo | 75 | 63.4 (8.6) | 44.2 (13.7) | 52 | ||||
| Calverley SCO30003, 2007w4 w19 | 44 centres in 42 countries | 156 | ERS | SFC 50/500 μg twice daily | 75 | 65 (8.3) | 44.3 (12.3) | 47 |
| Sal 50 μg | 76 | 65.1 (8.2) | 43.6 (12.6) | 45 | ||||
| Flu 500 μg twice daily | 75 | 65 (8.4) | 44.1 (12.3) | 47 | ||||
| Placebo | 76 | 65 (8.2) | 44.1 (12.3) | 51 | ||||
| Ferguson SCO40043, 2008w5 w20 | 94 centres in North America | 52 | ATS | SFC 50/250 μg twice daily | 58 | 64.9 (9.0) | 39.8 (13.9) | 15 |
| Sal 50 μg twice daily | 52 | 65.0 (9.1) | 50.6 (15.4) | 18 | ||||
| FLTA 3025, 2005w6 | 55 centres in the USA | 24 | ATS | Flu 500 μg twice daily | 66 | 63.3 (10) | 50 (NA) | NA |
| Flu 250 μg twice daily | 72 | 65.2 (8.7) | 49 (NA) | NA | ||||
| Placebo | 70 | 64.8 (9.5) | 48 (NA) | NA | ||||
| Hanania SFCA3007, 2003w7 w21 | 76 centres in the USA | 24 | ATS | SFC 50/250 μg twice daily | 61 | 63 (NA) | 41 (11) | 23 |
| Sal 50 μg twice daily | 58 | 64 (NA) | 42(12) | 20 | ||||
| Flu 250 μg twice daily | 66 | 63 (NA) | 42 (11) | 28 | ||||
| Placebo | 58 | 65 (NA) | 42 (12) | 30 | ||||
| Johnell, 20026 w22 | 39 centres in nine EU countries | 156 | FEV1/FVC <70% | Bud 400 μg twice daily | 74 (full cohort) | 52 (NA) | 77 (NA) | NA |
| Placebo | 72 (full cohort) | 52 (NA) | 77 (NA) | NA | ||||
| Kardos SCO30006, 2007w8 w23 | 95 centres in Germany | 52 | GOLD | SFC 50/500 μg twice daily | 74 | 63.8 (8.3) | 40.4 (8.9) | 40.6 |
| Sal 50 μg twice daily | 77.6 | 64 (8.2) | 40.3 (8.5) | 44.4 | ||||
| Mahler SFCA3006, 2002w9 w24 | Multicentre USA | 24 | ATS | SFC 50/500 μg twice daily | 62 | 61.9 (NA) | 41 (NA) | 28 |
| Sal 50 μg twice daily | 64 | 63.5 (NA) | 40 (NA) | 31 | ||||
| Flu 500 μg twice daily | 61 | 64.4 (NA) | 41 (NA) | 25 | ||||
| Placebo | 75 | 64 (NA) | 41 (NA) | 18 | ||||
| Paggiaro FLIT97, 1998w10 w25 | 13 European centres | 24 | ERS | Flu 500 μg twice daily | 99 | 62 (NA) | 59 (18) | NA |
| Placebo | 78 | 64 (NA) | 55 (17) | NA | ||||
| SCO100470, 2006w11 | 135 centres in Europe and Asia-Pacific | 24 | GOLD | SFC 50/250 μg twice daily | 78.3 | 63.5 (9.3) | 1654 (459)* | NA |
| Sal 50 μg twice daily | 77.2 | 63.7 (9.0) | 1681 (465)* | NA | ||||
| SCO40041, 2008w12 | 31 centres in the USA | 156 | FEV1/FVC ≤70% | SFC 50/250 μg twice daily | 60 | 65.4 (8.4) | <70% | NA |
| Sal 50 μg twice daily | 63 | 65.9 (9.5) | <70% | NA | ||||
| SFCT 01/SCO30002, 2005w13 | 49 centres in Italy and Poland | 52 | FEV1/VC <88% | Flu 500 μg twice daily | 84 | 64.6 (8.7) | NA | NA |
| Placebo | 80 | 65.7 (9.0) | NA | NA | ||||
| Tashkin, 2008w14 | 194 sites in five countries | 26 | Prebronchodilator FEV1 <50%, FEV1/FVC <70% | Bud 320/For 9 μg twice daily | 68 | 63 (9.0) | 33.7 (11.8) | NA |
| Bud 160/For 9 μg | 64 | 63 (9.0) | 34.1 (10.9) | NA | ||||
| Bud 160 μg + For 4.5 μg | 74 | 64 (9.0) | 33.5 (10.7) | NA | ||||
| Bud 160 μg | 68 | 63 (8.8) | 33.5 (10.8) | NA | ||||
| Form 4.5 μg | 66 | 64 (9.5) | 33.6 (11.3) | NA | ||||
| Placebo | 69 | 63 (9.6) | 34.6 (10.5) | NA | ||||
| Wouters SCO40002, 2005w15 w26 | 39 centres in The Netherlands | 52 | FEV1/VC <88% | SFC 50/500 μg twice daily | 73 | 63 (7.9) | 47.4 (13.9) | 85 |
| Sal 50 μg twice daily | 75 | 64 (7.7) | 48.2 (12.9) | 87 |
↵* Reported mean FEV1 in millilitres as a percentage of predicted unavailable.
↵† ATS and GOLD criteria for COPD are FEV1/FVC <70%.
↵‡ ERS criteria for COPD are FEV1/VC <88% predicted for men and <89% predicted for women.
ATS, American Thoracic Society; Bud, budesonide; COPD, chronic obstructive pulmonary disease; ERS, European Respiratory Society; FEV1, forced expiratory volume in the first second of expiration; Flu, fluticasone propionate; For, formoterol; FVC, forced vital capacity; GOLD, Global Initiative for Chronic Obstructive Lung Disease; ICS, inhaled corticosteroid; NA, not available; Sal, salmeterol xinafoate; SFC, combination of salmeterol and fluticasone; VC, vital capacity.