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Table 2 Summary of key spirometric measurements (ITT population)

From: A 28-day, randomized, double-blind, placebo-controlled, parallel group study of nebulized revefenacin in patients with chronic obstructive pulmonary disease

   Revefenacin
Placebo 44 μg 88 μg 175 μg 350 μg
D28a trough FEV1 change from baseline, mL
 n 55 60 63 59 63
 LS mean (SE) −32.4 (25.36) 19.4 (24.98) 155.0 (24.61) 134.2 (25.07) 138.2 (24.38)
 LS mean difference from placebo (95% CI) NA 51.8 (−17.3, 121.0) 187.4 (118.8, 256.1)** 166.6 (97.3, 236.0)** 170.6 (101.9, 239.3)**
D1 weighted mean FEV1(0–6h), mL
 n 69 66 68 70 70
 LS mean (SE) 33.3 (15.93) 145.1 (16.57) 193.8 (16.42) 180.0 (16.06) 214.9 (15.98)
 LS mean difference from placebo (95% CI) NA 111.7 (67.6, 155.9)** 160.5 (116.4, 204.5)** 146.7 (103.2, 190.2)** 181.5 (138.1, 225.0)**
D28 weighted mean FEV1(0–12h), mL
 n 55 63 63 59 64
 LS mean (SE) −32.8 (27.03) 34.3 (26.13) 129.8 (26.10) 123.4 (26.88) 143.1 (25.42)
 LS mean difference from placebo (95% CI) NA 67.1 (−4.9, 139.2) 162.6 (90.5, 234.7)** 156.2 (83.0, 229.4)** 176.0 (104.3, 247.7)**
D28 weighted mean FEV1(0–24h), mL
 n 54 59 63 59 62
 LS mean (SE) −78.1 (25.46) 3.4 (25.21) 87.0 (24.50) 84.1 (24.97) 96.3 (24.13)
 LS mean difference from placebo (95% CI) NA 81.5 (12.8, 150.2)* 165.1 (97.2, 233.0)** 162.1 (93.4, 230.8)** 174.3 (106.5, 242.2)**
  1. * p = 0.02, **p < 0.001 versus placebo
  2. Abbreviations: CI confidence interval, FEV 1 forced expiratory volume in 1 s, FEV 1(0–6) FEV1 over 0 to 6 h, FEV 1(0–12) FEV1 over 0 to 12 h, FEV 1(0–24) FEV1 over 0 to 24 h, ITT intent-to-treat, LS least squares, NA not applicable, SE standard error
  3. aD28 trough FEV1 measured on D29