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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