Table 2 Study Data for Trials Reporting Mean change in FEV1 and Patients Experiencing Moderate-to-Severe COPD Exacerbation
Author, Year | Treatment | Time point (weeks) | N Randomized | Annual exacerbation rate (M-S) | N with M-S exacerbation | Comparison data for Time to first exacerbation (Hazard ratio) | Mean change in Trough FEV1 (L) | Comparison data for Trough FEV1 (treatment difference) |
|---|---|---|---|---|---|---|---|---|
Anzueto, 2009 [23] | Fluticasone propionate/salmeterol 250 mcg/50 mcg bid | 52 | 394 | 1.1 | 208 | FP250 + S50 vs. S50: 0.73 | -0.017 | -- |
Salmeterol 50 mcg bid | 52 | 403 | 1.59 | 234 | -- | -0.097 | -- | |
Bateman, 2010 [10] | Tiotropium 5 μg orally inhaled once daily | 48 | 670 | 0.93 | 249 | -- | 0.08 | Tio5 vs. Placebo: 0.127 |
Tiotropium 10 μg orally inhaled once daily | 48 | 667 | 1.02 | 246 | -- | 0.11 | Tio10 vs. Placebo: 0.150 | |
Placebo | 48 | 653 | 1.91 | 288 | -- | -0.04 | ||
Dahl, 2010 [14] | Indacaterol 300 μg | 52 | 437 | 0.6 | 133 | -- | -- | Inda300 vs. Placebo: 0.16 |
Indacaterol 600 μg | 52 | 428 | 0.57 | 116 | -- | -- | Inda600 vs. Placebo: 0.15 | |
Formoterol | 52 | 435 | 0.56 | 126 | -- | -- | F vs. Placebo: 0.05 | |
Placebo | 52 | 432 | 0.74 | 145 | -- | -- | ||
Donohue, 2014 [24] | UMEC/VI 125/25 mcg | 52 | 226 | -- | 30 | UMEC/VI vs. Placebo: 0.6 | 0.18 | UMEC/VI vs. Placebo: 0.231 |
UMEC 125 mcg | 52 | 227 | -- | 34 | UMEC vs. Placebo: 0.4 | 0.13 | UMEC vs. Placebo: 0.178 | |
Placebo | 52 | 109 | -- | 26 | -- | -0.05 | -- | |
Ferguson, 2008 [17] | Fluticasone propionate/salmeterol (FSC) 250/50 | 52 | 394 | 1.06 | 211 | FP/S vs. S: 0.75 | -0.012 | -- |
Salmeterol 50 μg | 52 | 388 | 1.53 | 230 | -- | -0.082 | -- | |
Kerwin, 2012 [25] | NVA237 50 μg qd | 52 | 529 | 0.54 | NVA vs. Placebo: 0.66 | 0.112 | NVA vs. Placebo: 0.108 | |
Tiotropium 18 μg qd | 52 | 268 | -- | -- | NVA vs. Tio: 1.1 | 0.092 | NVA vs. Tio: 0.019 | |
Placebo | 52 | 269 | 0.8 | -- | -- | -0.097 | ||
Sharafkhaneh, 2012 [26] | Budesonide/formoterol pMDI 160/4.5 μg x 2 inhalations bid (320/9 μg) | 52 | 407 | 0.867 | 169 | -- | 0.07 | -- |
Budesonide/formoterol pMDI 80/4.5 μg x 2 inhalations bid (160/9 μg) | 52 | 408 | 0.952 | 173 | -- | 0.07 | -- | |
Formoterol DPI 4.5 μg x 2 inhalations bid (9 μg) | 52 | 404 | 1.171 | 182 | -- | 0.04 | -- | |
Tang, 2013 [27] | Tiotropium 5 μg (2 x 2.5 μg/puff) | 48 | 167 | -- | 58 | Tio5 vs. Placebo: 0.54 | -- | Tio5 vs. Placebo: 0.134 |
Placebo (2 puffs) | 48 | 171 | -- | 83 | -- | -- | -- | |
Tashkin, 2008 [11] | Tiotropium 18 μg once daily; followed by 40 μg of ipratropium four times daily for 30 days after 4 years of treatment. | 206 | 2987 | -- | 2001 | -- | 0.03 | -- |
Placebo once daily; followed by 40 μg of ipratropium four times daily for 30 days after 4 years of treatment. | 206 | 3006 | -- | 2049 | -- | -0.05 | -- | |
Calverley, 2009 [28] | Roflumilast 500 mcg once per day | 52 | 765 | 1.08 | 344 | ROLF500 vs. Placebo (Trial 1): 0.88 | 0.046 | ROLF500 vs. Placebo (Trial 1): 0.039 |
Placebo | 52 | 758 | 1.27 | 389 | -- | 0.008 | -- | |
Roflumilast 500 mcg once per day | 52 | 772 | 1.21 | 373 | ROLF500 vs. Placebo (Trial 2): 0.89 | 0.033 | ROLF500 vs. Placebo (Trial 2): 0.058 | |
Placebo | 52 | 796 | 1.49 | 432 | -- | -0.025 | -- | |
Dransfield, 2013 [22] | Vilanterol 25 μg | 52 | 409 | 1.05 | -- | FF200 + V vs. V: 0.9 | -0.04 | -- |
Fluticasone furoate 50 μg + Vilanterol 25 μg | 52 | 408 | 0.92 | -- | FF100 + V vs. V: 0.7 | 0 | -- | |
Fluticasone furoate 100 μg + Vilanterol 25 μg | 52 | 403 | 0.7 | -- | FF50 + V vs. V: 0.9 | 0.02 | -- | |
Fluticasone furoate 200 μg + Vilanterol 25 μg | 52 | 402 | 0.9 | -- | -- | 0.02 | -- | |
Vilanterol 25 μg | 52 | 409 | 1.14 | -- | FF200 + V vs. V: 0.7 | -0.02 | -- | |
Fluticasone furoate 50 μg + Vilanterol 25 μg | 52 | 412 | 0.92 | -- | FF100 + V vs. V: 0.8 | 0.02 | -- | |
Fluticasone furoate 100 μg + Vilanterol 25 μg | 52 | 403 | 0.9 | -- | FF50 + V vs. V: 0.9 | 0.01 | -- | |
Fluticasone furoate 200 μg + Vilanterol 25 μg | 52 | 409 | 0.79 | -- | -- | 0.01 | -- | |
Jones, 2011 [29] | Aclidinium 200 μg | 52 | 627 | 167 | Aclid200 vs. Placebo (Trial 1): 0.00 | -0.013 | ||
Placebo | 52 | 216 | 0.46 | 55 | -- | -0.065 | -- | |
Aclidinium 200 μg | 52 | 600 | 199 | -- | -0.009 | -- | ||
Placebo | 52 | 204 | 0.8 | 81 | -- | -0.024 | -- |