Table 2.
Studies on COPD
| Drugs | Baseline SGRQ | Final score | Statistical significancea | Clinical significance | Reference |
|---|---|---|---|---|---|
| Aclid 200 μg | 45.9 | -4.7 vs baseline | P = 0.013 vs plac. | 49 %* | Kerwin E.M., et al. COPD patients (ACCORD COPD I). COPD 9 90-101, 2012 [23] |
| Aclid 400 μg | 48.3 | -4.5 vs baseline | P = 0.019 vs plac. | 45 % | |
| plac | 45.1 | - 2 vs baseline | 36 % | ||
| Aclid 200 μg | 46.3 ± 16.8 | .-3.8 ± 1.1 vs plac | P < 0.001vs plac | 56.0 %** | Jones P.W., et al. Eur Resp Journal 40 830-836, 2012 [11] |
| Aclid 400 μg | 47.6 ± 17.7 | -4.6 ± 1.1 | P < 0.0001 vs | 57.3 %** | |
| plac | 45.1 ± 15.8 | plac. | 41.0 % | ||
| Aclid 200 μg | 48.5 | -5.3 vs baseline | ns | 41-6 % - 46.6 % | Gelb A.F., et al. Respiratory Medicine 107 1957-1965, 2013 [24] |
| Aclid 400 μg | 49.8 | -5.2 vs baseline | 45.2 % - 49.1 % | ||
| Glycopyr 50 μg | 46.11 | 39.50 | P = 0.004 | 56.8 % | D’Urzo A., et al. Respiratory Research 12 156, 2011 [25] |
| Plac | 46.34 | 42.31 | 46.3 % | ||
| P = 0.006 | |||||
| Glycopyr 50 μg | Not | -3.32 vs placebo | P < 0.001 | 54.3 % | Kerwin E., at al. European Respiratory Journal 40 1106-1114, 2012 [26] |
| Tio 18 μg | reported | -2.84 vs placebo | P = 0.014 | 59.4 % | |
| Plac | 50.8 % | ||||
| Indac 300 μg | 43 | -4.7 vs placebo | P < 0.001 vs plac | Not reported | Dahl R. et al. Thorax 65 473-479, 2010 [27] |
| Indac 600 μg | 44 | -4.6 vs placebo | |||
| Form | 44 | -4.0 vs placebo | |||
| Plac | 43 | ||||
| Indac 150 μg | 43 ± 18.6 | -5.0 vs baseline | P < 0.001 | 52.8 %** | Kornmann O. et al. European Respiratory Journal 37 273-279, 2011 [28] |
| Salm 50 μg | 44. ± 18.4 | -4.1 vs baseline | P < 0.001 | 48.6 %*** | |
| plac | 44 ± 18.1 | 38.0 % | |||
| Indac 150 μg | Not reported | -3.3 vs placebo**** | P < 0.001 vs plac | - | Donohue J.F. et al. Am J Respir Crit Care Med 182 155-162, 2010 [29] |
| Indac 300 μg | -2.4 vs placebo | P < 0.01 vs plac | |||
| Tio 18 μg | -1.0 vs placebo | Ns vs plac | |||
| plac | |||||
| Indac 150 μg | 42.3 ± 17.60 | 37.1 ± 0.56 | P < 0.001 | 50.5 % | Buhl R. et al. Eur Respir J 38 797-803, 2011 [30] |
| Tio 18 μg | 42.7 ± 18.04 | 39.2 ± 0.55 | 42.5 % | ||
| p ≤ 0.001 | |||||
| Indac 150 μg | 47.9 | 42.3 | P = 0.73 | 49 % | Decramer M.L. et al. Lancet Respir Med 1 524-533, 2013 [31] |
| Tio 18 μg | 48.7 | 42.2 | 49 & | ||
| Tio 5 μg | Not reported | -4.7 vs baseline | P < 0.0001 | 49.5 % | Bateman E.D. et al. Respiratory Medicine 104, 1460-1472, 2010 [32] |
| P lac | -1.8 vs baseline | 41.4 % | |||
| P < 0.0001 | |||||
| Tio 18 μg emphysema | 46.7 ± 3.0 | 39.4 ± 2.7 | ns | Not reported | Fujimoto K. et al. International Journal of COPD 6, 219-227, 2011 [33] |
| Tio 18 μg non emphys | 35.1 ± 6.4 | 26.9 ± 4.6 | |||
| Salm 50 μg emphysema | 38.6 ± 3.5 | 33.0 ± 3.2 | |||
| Salm 50 μg nonemphys | 37.5 ± 8.5 | 29.3 ± 7.4 | |||
| Tio 18 μg | 46.1 ± 19.1 | -4.5 vs baseline | P < 0.05 | Not reported | Hoshino M. et al Respirology 16 95-101, 2011 [34] |
| Tio + Salm/flut 50/250 μg | 42.7 ± 17.0 | -10.2 vs baseline | |||
| Umec 62.5 μg | Not reported | -3.14 vs baseline | P < 0.001 both doses of umeclidinium vs placebo | Not reported | Trivedi R. et al. Eur Respiratory J 43 72-81, 2014 [35] |
| Umec 125 μg | -6.12 vs baseline | ||||
| Plac | +4.75 vs baseline | ||||
| Beclom/form 100/6 μg | 60.4 ± 19.5 | -3.75 ± 13.91 | ns | 25.40 % | Calverley P.M.A. et al. Respiratory Medicine 104 1858-1868, 2010 [36] |
| Bud/form 200/6 μg | 57.2 ± 18.6 | -4.28 ± 11.92 | 21.90 % | ||
| Form 12 μg | 59.5 ± 20.2 | -2.90 ± 13.28 | 25.30 % | ||
| Tio + bud/form | Not reported | -3.8 vs baseline | P = 0.023 | 49.5 % | Welte T. et al. Am J Respir Crit Care Med 180 741-750, 2009 [37] |
| Tio + plac | -1.5 vs baseline | 40.0 % | |||
| P = 0.016 | |||||
| Bud/form 320/9 μg | 55.9 (17.6) | -7.2 (1.18) vs bas. | ns | Sharafkhaneh A. et al. Respiratory Medicine 106, 2257-268 2012 [38] | |
| Bud/form 160/9 μg | 57.8 (16.7) | -5.5 (1.17) vs bas. | |||
| Form 9 μg | 58.6 (16.9) | -5.9 (1.17) vs bas. | |||
| Indac/Glycopyr 110/50 μg | 42.01 | 35.45 | ns | 55.5 % | Vogelmeier C.F. et al. Lancet Respir Med 1 51-60, 2013 [39] |
| Salm/flut 50/500 μg | 42.72 | 36.68 | 49.1 % | ||
| Indat/Glycopyr 110/50 μg | 53 (18) | 43.8 | glycop/indacat | 57 % | Wedzicha J.A. et al. Lancet Respir Med 1 199-209, 2013 [40] |
| Glycopyr 50 μg | 52 (18) | 45.8 | P = 0.0067 e | 52 % | |
| Tio 18 μg | 52 (17) | 46.0 | P = 0.00037 vs competitors | 51 % | |
| Glycopir/indacat p = 0.055 e p = 0.051 vs competitors | |||||
| Indac 150 μg + Glycopyr 50 μg | Not reported | - 6.22 (11.47) | ns | 56.5 % | Vincken W. et al. Int Journal of COPD 9 215-228, 2014 [41] |
| Indac 150 μg | - 4.13 (10.38) vs baseline | 46.8 % ns | |||
| Beclom/form 200/12 μg | 47.0 (16.7) | -5.92 | P = 0.08 | 45.0 % | Singh D. et al. BMC Pulmonary Medicine 14 43 2014 [42] |
| Flutic/salm 500/50 μg | 45.2 (16.5) | -3.80 | 36.2 % | ||
| ns | |||||
| Umec/Vil 62.5/25 μg | Not reported | -8.07 (0.749) | p ≤ 0.001 vs | 49 % | Donohue J.F. et al. Respiratory Medicine 107 1538-1546, 2013 [43] |
| Umec 62.5 μg | -7.25 (0.753) | placebo | 44 % | ||
| Vil25 μg | -7.75 (0.760) | 48 % | |||
| Plac | -2.56 (0.950) vs baseline | 34 % | |||
| Umec/Vil125/25 μg | Not reported | 40.10 (0.665) | Combination | 49 % | Celli B. et al Chest 145 (5) 981-991, 2014 [44] |
| Umec125 μg | 43.38 (0.664) | p ≤ 0.001 vs umec e | 40 % | ||
| Vil 25 μg | 42.82 (0.681) | p <0.01 vs | 41 % | ||
| Plac | 43.69 (0.875) | vilanterol | 37 % |
aBetween groups
*p < 0.005 vs placebo
**p < 0.001 vs placebo
***p < 0.01
****p < 0.01 vs tiotropium