Table 4 Study Data for Trials Reporting Mean change in SGRQ Total Score 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 SGRQ Total Score | Comparison data for SGRQ (treatment difference) |
|---|---|---|---|---|---|---|---|---|
Anzueto, 2009 [23] | Fluticasone propionate/salmeterol 250 mcg/50 μg bid | 52 | 394 | 1.1 | 208 | FP250 + S50 vs. S50: 0.73 | 2.49 | FP250 + S50 vs. S50: -0.81 |
Salmeterol 50 μg bid | 52 | 403 | 1.59 | 234 | -- | 3.28 | -- | |
Bateman, 2010 [20] | Tiotropium 5 μg orally inhaled once daily | 48 | 670 | 0.93 | 249 | -- | -5.1 | Tio5 vs. Placebo: -3.5 |
Tiotropium 10 μg orally inhaled once daily | 48 | 667 | 1.02 | 246 | -- | -5.5 | Tio10 vs. Placebo: -3.8 | |
Placebo | 48 | 653 | 1.91 | 288 | -- | -1.6 | -- | |
Dahl, 2010 [14] | Indacaterol 300 μg | 52 | 437 | 0.6 | 133 | -- | -6.5 | Inda300 vs. Placebo: -4.7 |
Indacaterol 600 μg | 52 | 428 | 0.57 | 116 | -- | -7.2 | Inda600 vs. Placebo: -4.6 | |
Formoterol | 52 | 435 | 0.56 | 126 | -- | -7 | F vs. Placebo: -4 | |
Placebo | 52 | 432 | 0.74 | 145 | -- | -1.7 | -- | |
Ferguson, 2008 [17] | Fluticasone propionate/salmeterol (FSC) 250/50 | 52 | 394 | 1.06 | 211 | FP + S vs. S: 0.75 | -3.49 | FP/S vs. S: -1.86 |
Salmeterol 50 μg | 52 | 388 | 1.53 | 230 | -- | -1.86 | -- | |
Hagedorn, 2013 [33] | Salmeterol xinafoate/fluticasone propionate via a single inhaler (SFC) | 52 | 108 | 0.81 | 42 | -- | -1.8 | -- |
Salmeterol xinafoate/fluticasone propionate via separate inhalers (Sal/FP) | 52 | 106 | 0.98 | 44 | -- | -2.6 | -- | |
Kerwin, 2012 [25] | NVA237 50 μg qd | 52 | 529 | 0.54 | -- | NVA vs. Placebo: 0.66 | -- | NVA vs. Placebo: -3.32 |
Tiotropium 18 μg qd | 52 | 268 | -- | NVA vs. Tio: 1.1 | -- | NVA vs. Tio: -0.48 | ||
Placebo | 52 | 269 | 0.8 | -- | -- | -- | -- | |
Sharafkhaneh, 2012 [26] | Budesonide/formoterol pMDI 160/4.5 μg x 2 inhalations bid (320/9 μg) | 52 | 407 | 0.867 | 169 | -- | -7.2 | -- |
Budesonide/formoterol pMDI 80/4.5 μg x 2 inhalations bid (160/9 μg) | 52 | 408 | 0.952 | 173 | -- | -5.5 | -- | |
Formoterol DPI 4.5 μg x 2 inhalations bid (9 μg) | 52 | 404 | 1.171 | 182 | -- | -5.9 | -- | |
Tang, 2013 [27] | Tiotropium 5 μg (2 x 2.5 μg/puff) | 48 | 167 | -- | 58 | Tio5 vs. Placebo: 0.54 | -7.1 | Tio5 vs. Placebo: -3.9 |
Placebo (2 puffs) | 48 | 171 | -- | 83 | -- | -3.3 | -- | |
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 | -- | -1.25 | -- |
Placebo once daily; followed by 40 μg of ipratropium four times daily for 30 days after 4 years of treatment. | 206 | 3006 | -- | 2049 | -- | -1.21 | -- | |
Wedzicha, 2008 [34] | Salmeterol 50 μg + fluticasone propionate 500 μg bid | 104 | 658 | -- | 408 | -- | -1.7 | -- |
Tiotropium bromide 18 μg once daily | 104 | 665 | -- | 392 | -- | 0.37 | S + F vs. Tio18: -2.07 | |
Jones, 2011 [29] | Aclidinium 200 μg | 52 | 627 | -- | 167 | Aclid200 vs. Placebo (trial 1): 1.00 | -- | Aclid200 vs. Placebo (trial 1): -1.53 |
Placebo | 52 | 216 | -- | 55 | -- | -- | -- | |
Aclidinium 200 μg | 52 | 600 | -- | 199 | -- | -- | Aclid200 vs. Placebo (trial 2): -2.21 | |
Placebo | 52 | 204 | -- | 81 | -- | -- | -- |