TABLE 1.
Characteristics of included studies.
| Registered ID of Trials | Study setting | Study design | Intervention vs. Control Group (n) | Age (years) | Gender: Male (%) | BMI (kg/m2) | Race: white (%) | Current smokers (%) | Current ICS/LABA users (%) | Baseline FEV1 (ml) | Follow-up time after first treatment (weeks) | Outcomes |
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT02040792 | United States | Parallel | Placebo, Qd (70) | 61.9 ± 8.63 | 178 (50.28) | 27.9 ± 5.93 | 324 (91.52) | 190 (53.67) | 130 (36.72 | 1,283 ± 457 | 4 | A; B; C |
| REV, 44 μg, Qd (68) | ||||||||||||
| REV, 88 μg, Qd (71) | ||||||||||||
| REV, 175 μg, Qd (71) | ||||||||||||
| REV, 350 μg, Qd (74) | ||||||||||||
| NCT02518139 | United States | Parallel | REV, 88 μg, Qd (364) | 64.4 ± 8.97 | 616 (58.39) | 28.8 ± 6.6 | 977 (92.61) | 489 (46.35) | 560 (53.08) | 1,350 ± 520 | 52 | A; B; C |
| REV, 175 μg, Qd (335) | 29.1 ± 6.8 | 1,340 ± 490 | ||||||||||
| TIO, 18 μg, Qd (356) | 28.8 ± 6.3 | 1,310 ± 490 | ||||||||||
| NCT02459080 | United States | Parallel | placebo, Qd (209) | 64.1 ± 8.87 | 317 (51.21) | 29.4 ± 6.6 | 564 (91.11) | 301 (48.63) | 260 (42.00) | 1,400 ± 500 | 12 | A; B; C |
| REV, 88 μg, Qd (212) | 29.1 ± 6.2 | 1,300 ± 400 | ||||||||||
| REV, 175 μg, Qd (198) | 29.6 ± 7.2 | 1,400 ± 500 | ||||||||||
| NCT02512510 | United States | Parallel | placebo, Qd (208) | 63.4 ± 8.95 | 302 (49.51) | 29.3 ± 6.9 | 545 (89.34) | 286 (46.88) | 249 (40.82) | 1,300 ± 500 | 12 | A; B; C |
| REV, 88 μg, Qd (205) | 29.2 ± 7.7 | 1,300 ± 500 | ||||||||||
| REV, 175 μg, Qd (197) | 28.9 ± 7.0 | 1,300 ± 500 | ||||||||||
| NCT03095456 | United States | Parallel | REV, 175 μg, Qd (102) | 65.1 ± 8.13 | 124 (60.19) | NA | 185 (89.80) | 96 (46.60) | 111 (53.88) | 900 ± 500 | 4 | A; B; C |
| TIO, 18 μg, Qd (104) | ||||||||||||
| NCT03573817 | United States | Parallel | REV, 175 µg, Qd | 63.7 ± 8.56 | 69 (56.56) | 29.17 ± 6.475 | 116 (95.08) | 69 (56.56) | 28 (22.95) | 1,340 ± 480 1,340 ± 500 | 6 | B; C |
| + FOR, 20 µg, Bid (63) | ||||||||||||
| Placebo, Qd | ||||||||||||
| + FOR, 20 µg, Bid (59) | ||||||||||||
| NCT01704404 | United KingdomNorthern Ireland New Zealand | Crossover | REV, 22 μg, Qd (40) | 63.9 (45–75) | 33 (55.93 | 28.8 ± 5.92 | 59 (100) | NA | 0 (0) | 1,600 ± 500 | 1 | A; B; C |
| REV, 44 μg, Qd (39) | ||||||||||||
| REV, 88 μg, Qd (39) | ||||||||||||
| REV, 175 μg, Qd (39) | ||||||||||||
| REV, 350 μg, Qd (39) | ||||||||||||
| REV, 700 μg, Qd (40) | ||||||||||||
| Placebo, Qd (59) | ||||||||||||
| NCT02109172 | United States | Crossover | REV, 44 μg, Bid (64) | 40–65: n = 39 y≥ 65: n = 25 | 37 (57.81) | NA | NA | NA | NA | NA | 1 | B; C |
| REV, 175 μg, Qd (64) | ||||||||||||
| Placebo, Qd (64) | ||||||||||||
| NCT03064113 Or U1111-1,120–8,290 | South Africa New Zealand | Crossover | Placebo, Qd (32) | 18–65: n = 22 y≥ 65: n = 10 | 22 (68.75%) | 27.72 ± 8.0 | 28 (87.5) | NA | NA | 1900 ± 500 | 1 day | B; C |
| REV, 350 μg, Qd (32) | ||||||||||||
| REV, 700 μg, Qd (32) | ||||||||||||
| IPR, 500 μg, Qd (32) |
n: sample size; BMI: body mass index; FEV1: Forced Expiratory Volume in 1 s; REV: revefenacin; TIO: tiotropium; FOR: formoterol; IPR: ipratropium; NA: not applicable; A: change from baseline in trough FEV1; B: total adverse events (AEs); C: serious adverse events (SAEs).