Table 1.
Responsiveness of the COPD Assessment Test to Pharmacological Interventions in Patients with COPD
| Study | Treatment Arms | Patients (N) | Duration | Baseline CAT Score [Mean (SD) or Range] | CAT Change from Baseline/Treatment Difference [Mean (SD)] | CAT Responders [% (n) or OR (95% CI)] |
|---|---|---|---|---|---|---|
| Decramer et al., 2014 (35) | UMEC 125 μg/VI 25 μg, UMEC 62.5 μg/VI 25 μg, TIO 18 μg, and either VI 25 μg (study 1) or UMEC 125 μg (study 2) | Study 1: 208, 209, 214, and 212 | 24 wk | Study 1: 17.19–18.95 | Change from baseline in study 1: −2.83 (7.447); −2.45 (6.954); −3.07 (7.032); −2.67 (6.839) | Not reported |
| Study 2: 215, 222, 215, and 217 | Study 2: 16.96–17.76 | Change from baseline in study 2: −3.46 (6.711); −3.18 (7.178); −2.32 (6.980); −3.02 (7.212) | ||||
| Zhong et al., 2015 (36); LANTERN | IND/GLY 110/50 μg once daily | 343 | 26 wk | 13.7 (5.94) | Week 12: LSM (SE) IND/GLY, 11.7 (0.43); treatment difference vs. SFC, 0.3 (−0.4 to 0.9) | Not reported |
| Week 26: LSM (SE) IND/GLY, 11.1 (0.46); treatment difference vs. SFC, −0.2 (−0.9 to 0.6) | ||||||
| SFC 50/500 μg | 333 | 13.8 (6.78) | Week 12: LSM (SE) SFC, 11.5 (0.42) | |||
| Week 26: LSM (SE) SFC, 11.2 (0.46) | ||||||
| Siler et al., 2016 (37); two studies | 12 wk | Change from baseline: | Not reported | |||
| Study 1 | PBO + FP/SAL 250/50 μg | 179 | 18.16 (7.02) | −0.77 (5.697) | ||
| UMEC 62.5 + FP/SAL 250/50 μg | 190 | 17.79 (7.40) | −0.81 (5.543) | |||
| UMEC 125 + FP/SAL 250/50 μg | 185 | 18.71 (6.92) | −0.92 (5.112) | |||
| Study 2 | PBO + FP/SAL 250/50 μg | 172 | 18.08 (7.43) | 0.41 (5.445) | ||
| UMEC 62.5 + FP/SAL 250/50 μg | 180 | 18.12 (7.35) | −1.31 (7.182) | |||
| UMEC 125 + FP/SAL 250/50 μg | 184 | 17.02 (7.08) | −1.42 (5.880) | |||
| Pavord et al., 2017 (38); METREO/METREX | 52 wk | |||||
| METREX mITT* | Mepolizumab 100 mg | 233 | 18.5 (7.8) | Change from baseline: −0.8 (0.5) | ||
| Difference vs. placebo: −0.8 (95% CI, −2.0 to 0.5) | ||||||
| Placebo | 229 | 19.6 (7.7) | Change from baseline: 0.0 (0.5) | |||
| Population with an eosinophilic phenotype† | Mepolizumab 100 mg | 417 | 18.6 (7.6) | Change from baseline: −1.0 (0.3) | MEPO: 37% | |
| Difference vs. placebo: −0.6 (95% CI, −1.5 to 0.4) | MEPO vs. PBO: OR, 1.21 (95% CI, 0.80 to 1.82) | |||||
| Placebo | 419 | 19.1 (7.7) | Change from baseline: −0.4 (0.4) | PBO: 35% | ||
| METREO mITT population* | Mepolizumab 100 mg | 223 | 18.7 (7.4) | Change from baseline: −1.6 (0.42) | MEPO 100: 42% | |
| Difference vs. placebo: −1.1 (95% CI, −2.3 to 0.0) | MEPO 100 vs. PBO: OR, 1.66 (95% CI, 1.10 to 2.50) | |||||
| Mepolizumab 300 mg | 225 | 19.4 (7.8) | Change from baseline: −0.8 (0.42) | MEPO 300: 41% | ||
| Difference vs. placebo: −0.4 (95% CI, −1.5 to 0.8) | MEPO 300 vs. PBO: OR, 1.58 (95% CI, 1.05 to 2.37) | |||||
| Placebo | 226 | 19.4 (7.5) | Change from baseline: −0.4 (0.42) | PBO: 32% | ||
| Tabberer et al., 2018 (39); FULFIL | ||||||
| ITT population | FF/UMEC/VI 100/62.5/25 μg | 5,911 | 24 wk | 17.6 (6.43) | Change from baseline: FF/UMEC/VI: Week 4, −1.7; Week 24, −2.7 | Week 24: |
| FF/UMEC/VI: 53% | ||||||
| BUD/FOR: 45% | ||||||
| FF/UMEC/VI vs. BUD/FOR: OR, 1.44 | ||||||
| BUD/FOR 400/12 μg | 5,899 | 17.8 (6.24) | Change from baseline: BUD/FOR: Week 4, −1.4; Week 24, −1.7 | |||
| Treatment differences at Weeks 4 and 24: −0.7 and −0.9 units | ||||||
| EXT population | FF/UMEC/VI 100/62.5/25 μg | 5,210 | 52 wk | 18.1 (6.29) | Treatment differences at Week 52: −0.2 | Week 52: FF/UMEC/VI: 44% BUD/FOR: 35%; FF/UMEC/VI vs. BUD/FOR: OR, 1.50 |
| BUD/FOR 400/12 μg | 5,220 | 17.7 (5.93) | ||||
| Tamási et al., 2018 (56); RWE study | Dose/regimens per physician decision | 12 wk | Not reported | |||
| BUD/FOR: COPD 2 × 2 inhalations per day of either 160/4.5 μg or 320/9 μg | 778 | 24.2 (5.7) | Mean (SD) at 12 wk: 18.2 (5.1) | |||
| ACO treated in accordance with GINA | 99 | 23.7 (6.5) | Mean (SD) at 12 wk: 18.3 (4.7) | |||
| Kostikas et al., 2018 (57); CRYSTAL | IND/GLY 110/50 μg or GLY 50 μg | 4,324 | 12 wk | 13.2 (6.50) | Not reported | 36.7% (1,585) |
| Riley et al., 2018 (41) | UMEC/VI 62.5/25 μg or PBO (crossover) | 198/198 | 12 wk | Not reported | Treatment difference: −1.07 (95% CI, −2.09 to −0.05) | Not reported |
| Lipson et al., 2018 (20); IMPACT | 10,355 | 52 wk | Not reported | Change from baseline: | FF/UMEC/VI vs. FF/VI: OR, 1.24 (95% CI, 1.14 to 1.36) | |
| FF/UMEC/VI 100/62.5/25 μg | −2.0 | |||||
| FF/VI 100/25 μg | −1.5 | |||||
| UMEC/VI 62.5/25 μg | −1.6 | FF/UMEC/VI vs. UMEC/VI: OR, 1.28 (95% CI, 1.15 to 1.43) | ||||
| Kardos et al., 2018 (44); DACOTA/DINO | Roflumilast as per local label | 24 wk | Change from baseline: | |||
| DINO | 5,375 | 26.8 (7.0) | −9.0 | 85.8% | ||
| DACOTA | 3,597 | 25.4 (6.9) | −6.4 | 72.8% | ||
| Frith et al., 2018 (42); FLASH | IND/GLY 110/50 μg and placebo for SFC | 248 | 12 wk | 17.9 (5.59) | Week 12: mean (SD), 13.4 | Not reported |
| SFC 50/500 μg twice daily and placebo for IND/GLY | 250 | 17.8 (6.09) | Week 12: mean (SD), 13.8 | |||
| Treatment difference: −0.4 (95% CI, −1.3 to 0.4) | ||||||
| Papi et al., 2018 (45); TRIBUTE | BDP/FF/GLY 87/5/9 μg | 764 | 26 wk | Not reported | Changes from baseline: −0.8 | Not reported |
| IND/GLY 85/43 μg | 768 | 52 wk | Changes from baseline: −0.6 | |||
| Calverley et al., 2018 (43); DYNAGITO | TIO/OLO 5/5 μg | 3,939 | 52 wk | 18.8 (7.4) | Treatment difference TIO/OLO vs. TIO over 52 wk varied between −0.4 (SE 0.15) and −0.7 (0.13) | TIO/OLO vs. TIO: OR, 1.17 (95% CI, 1.06 to 1.28) |
| TIO 5 μg | 3,941 | 18.4 (7.4) | ||||
| Kaplan et al., 2018 (58); POWER | IND/GLY 110/50 μg | IND/GLY from TIO: 248 | 4 and 16 wk | IND/GLY from TIO: 18.1 (6.1) | Change from baseline: | Not reported |
| IND/GLY from SFC: 21.1 (6.9) | Week 4: | |||||
| IND/GLY from SFC: 87 | All IND/GLY: 18.9 (6.4) | IND/GLY from TIO: −4.7 (95% CI, −5.4 to −3.9) | ||||
| IND/GLY from SFC FDC: −5.9 (95% CI, −7.6 to −4.2) | ||||||
| All IND/GLY: 338 | Week 16: | |||||
| IND/GLY from TIO: −5.9 (95% CI, −6.7 to −5.1) | ||||||
| IND/GLY from SFC FDC: −8.2 (95% CI, −10.0 to −6.4) | ||||||
| All IND/GLY: −6.5 (95% CI, −7.3 to −5.7) |
Definition of abbreviations: BDP = beclomethasone dipropionate; BUD = budesonide; CI = confidence interval; CAT = COPD Assessment Test; COPD = chronic obstructive pulmonary disease; FDC = fixed-dose combination; FF = fluticasone furoate; FOR = formoterol; FP = fluticasone propionate; GINA = Global Initiative for Asthma; GLY = glycopyrronium; IND = indacaterol; LSM = least-squares means; mITT = modified intention to treat; OLO = olodaterol; OR = odds ratio; PBO = placebo; SAL = salmeterol; SFC = salmeterol–fluticasone combination; TIO = tiotropium; UMEC = umeclidinium; VI = vilanterol.
*
The METREX mITT population included patients who received at least one dose of mepolizumab or placebo.
†
The METREX mITT population with an eosinophilic phenotype included patients who received at least one dose of mepolizumab or placebo and had an eosinophil count greater than or equal to 150 cells/mm3 at screening or greater than or equal to 300 cells/mm3 within the previous year.