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Table 2 Baseline comparison for primary and secondary efficacy endpoints at Day 29 (ITT population)

From: Functional respiratory imaging assessment of budesonide/glycopyrrolate/formoterol fumarate and glycopyrrolate/formoterol fumarate metered dose inhalers in patients with COPD: the value of inhaled corticosteroids

 

BGF

320/18/9.6 µg

(N = 22)

GFF

18/9.6 µg

(N = 23)

Primary FRI endpoints

 Untrimmed siVaw at TLCa

  

  Geometric mean, mL/L

2.05

2.00

  Ratio to baseline (95% CI)

1.72 (1.38, 2.13)****

1.53 (1.28, 1.83)****

 Untrimmed siRaw at TLCa

  

  Geometric mean, kPa·s

0.21

0.20

  Ratio to baseline (95% CI)

0.50 (0.39, 0.63)****

0.52 (0.40, 0.67)****

Secondary endpoints

 FRI

  iVaw at TLCa

  

   Geometric mean, mL

2.74

2.71

   Ratio to baseline (95% CI)

1.70 (1.37, 2.11)****

1.51 (1.26, 1.80)****

  iRaw at TLCa

  

   Geometric mean, kPa·s/L

0.18

0.16

   Ratio to baseline (95% CI)

0.50 (0.40, 0.63)****

0.52 (0.40, 0.68)****

 Spirometry

  Post-dose FEV1b

  

   Mean change from baseline (95% CI), mL

346 (182, 509)***

273 (140, 405)***

 Body plethysmography

  FRCc

  

   Mean change from baseline (95% CI), mL

–280 (–770, 210)

–500 (–810, –180)**

Other endpoints

  

 FVCb

  

  Mean change from baseline (95% CI), mL

422 (180, 663)**

302 (119, 485)**

 FEF25–75b

  

  Mean change from baseline (95% CI), mL/s

263 (17, 509)*

83 (–153, 319)

  1. aBased on n = 20 for BGF and n = 21 for GFF
  2. bBased on n = 21 for BGF and for GFF
  3. cBased on n = 22 for BGF and n = 21 for GFF
  4. *p < 0.05; **p < 0.01; ***p < 0.001; ****p ≤ 0.0001
  5. BGF budesonide/glycopyrrolate/formoterol fumarate, CI confidence interval, FEF25–75 forced expiratory flow 25–75% of FVC, FEV1 forced expiratory volume in 1 s, FRC functional residual capacity, FRI functional respiratory imaging, FVC forced vital capacity, GFF glycopyrrolate/formoterol fumarate, iRaw image-based airway resistance, ITT intent-to-treat, iVaw image-based airway volume, siRaw specific image-based airway resistance, siVaw specific image-based airway volume, TLC total lung capacity