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Table 2 Primary and Secondary Pharmacodynamic Endpoints (Per Protocol Population)

From: Navafenterol (AZD8871) in patients with COPD: a randomized, double-blind, phase I study evaluating safety and pharmacodynamics of single doses of this novel, inhaled, long-acting, dual-pharmacology bronchodilator

Change From Baseline

Placebo (n = 32)a

navafenterol 400 μg (n = 34)

navafenterol 1800 μg (n = 31)

Indacaterol 150 μg (n = 32)

Tiotropium 18 μg (n = 30)

Trough FEV1 on day 2, L (primary endpoint)

 Trough FEV1 value

−0.040 (− 0.093, 0.013)

0.071 (0.019, 0.123)

0.170 (0.166, 0.224)

0.101 (0.048, 0.154)

0.105 (0.051, 0.159)

 Difference vs placebo

 

0.111 (0.059, 0.163)

0.210 (0.156, 0.264)

0.141 (0.087, 0.195)

0.145 (0.090, 0.200)

 P-value

 

< .0001

< .0001

< .0001

< .0001

 Difference vs indacaterol

 

−0.030 (−0.083, 0.023)

0.0689 (0.015, 0.123)

  

 P-value

 

.2600

.0126

  

 Difference vs tiotropium

 

−0.034 (−0.088, 0.020)

0.0651 (0.011, 0.120)

  

 P-value

 

.2141

.0197

  

Peak FEV1 on day 1, L

 Peak FEV1 value

0.121 (0.044, 0.198)

0.339 (0.264, 0.413)

0.406 (0.328, 0.483)

0.348 (0.271, 0.424)

0.260 (0.181, 0.340)

 Difference vs placebo

 

0.218 (0.122, 0.314)

0.285 (0.186, 0.384)

0.227 (0.128, 0.326)

0.139 (0.039, 0.240)

 P-value

 

< .0001

< .0001

< .0001

.0069

 Difference vs indacaterol

 

−0.009 (−0.106, 0.088)

0.058 (−0.041, 0.157)

  

 P-value

 

.8556

.2476

  

 Difference vs tiotropium

 

0.079 (−0.020, 0.178)

0.146 (0.045, 0.246)

  

 P-value

 

.1180

.0048

  

Normalized AUC0–24 of FEV1, L

 Normalized FEV1 AUC0–24 value

−0.021 (−0.075, 0.032)

0.168 (0.115, 0.221)

0.255 (0.201, 0.309)

0.159 (0.105, 0.212)

0.126 (0.072, 0.180)

 Difference vs placebo

 

0.189 (0.150, 0.228)

0.276 (0.236, 0.316)

0.180 (0.139, 0.220)

0.147 (0.106, 0.188)

 P-value

 

< .0001

< .0001

< .0001

< .0001

 Difference vs indacaterol

 

0.010 (−0.030, 0.049)

0.096 (0.056, 0.136)

  

 P-value

 

.6305

< .0001

  

 Difference vs tiotropium

 

0.042 (0.002, 0.082)

0.129 (0.088, 0.169)

  

 P-value

 

.0406

< .0001

  

Normalized AUC0–12 of FEV1, L

 Normalized FEV1 AUC0–12 value

−0.022 (−0.081, 0.036)

0.233 (0.175, 0.290)

0.301 (0.242, 0.359)

0.192 (0.134, 0.250)

0.156 (0.096, 0.215)

 Difference vs placebo

 

0.255 (0.211, 0.299)

0.323 (0.278, 0.368)

0.214 (0.169, 0.260)

0.178 (0.132, 0.224)

 P-value

 

< .0001

< .0001

< .0001

< .0001

 Difference vs indacaterol

 

0.041 (−0.004, 0.085)

0.109 (0.063, 0.154)

  

 P-value

 

.0732

< .0001

  

 Difference vs tiotropium

 

0.077 (0.032, 0.123)

0.145 (0.099, 0.191)

  

 P-value

 

.0010

< .0001

  

Normalized AUC12–24 of FEV1, L

 Normalized FEV1 AUC12–24 value

−0.029 (−0.083, 0.025)

0.104 (0.052, 0.156)

0.212 (0.158, 0.266)

0.128 (0.075, 0.181)

0.100 (0.045, 0.154)

 Difference vs placebo

 

0.133 (0.085, 0.180)

0.241 (0.192, 0.289)

0.157 (0.108, 0.205)

0.129 (0.079, 0.178)

 P-value

 

< .0001

< .0001

< .0001

< .0001

 Difference vs indacaterol

 

−0.024 (−0.071, 0.023)

0.084 (0.037, 0.131)

  

 P-value

 

.3172

.0007

  

 Difference vs tiotropium

 

0.004 (−0.044, 0.052)

0.112 (0.064, 0.160)

  

 P-value

 

.8591

< .0001

  
  1. AUC0–24 area under the curve from 0 to 24 h post-dose, AUC0–12 area under the curve from 0 to 12 h post-dose, AUC12–24 area under the curve from 12 to 24 h post-dose, FEV1 forced expiratory volume in 1 s. Values are least squares means (95% confidence interval).
  2. aTwo patients from the placebo group were excluded from the normalized FEV1 AUC12–24 analysis due to missing data. One patient was missing data from 12 to 24 h post-dose and the other from 14 h post-dose. For all other endpoints in this table, all patients exposed to each treatment were included in the analyses
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Respiratory Research

ISSN: 1465-993X

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