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Table 3 Treatment 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 LSM, mL/L

2.04

1.87

  LSM ratio, BGF versus GFF (95% CI)

1.09 (1.03, 1.16)**

 Untrimmed siRaw at TLCa

  

  Geometric LSM, kPa·s

0.18

0.19

  LSM ratio, BGF versus GFF (95% CI)

0.97 (0.85, 1.10)

Secondary endpoints

 FRI

  Untrimmed iVaw at TLCa

  

   Geometric LSM, mL

2.62

2.38

   LSM ratio, BGF versus GFF (95% CI)

1.10 (1.03, 1.17)**

  iRaw at TLCa

  

   Geometric LSM, kPa s/L

0.14

0.15

   LSM ratio, BGF versus GFF (95% CI)

0.96 (0.85, 1.09)

 Spirometry

  FEV1 b

  

   LS mean change from baseline (SE), mL

341 (69)

282 (69)

   LSM difference, BGF versus GFF (95% CI)

60 (–14, 133)

 Body plethysmography

  FRC, mL (95% CI)c

  

   LS mean change from baseline (SE)

–310 (140)

–460 (142)

   LSM difference, BGF versus GFF (95% CI)

150 (–230, 530)

Other endpoints

 

 FVCc

 

  LS mean change from baseline (SE), mL

393 (94)

299 (95)

  LSM difference, BGF versus GFF (95% CI)

94 (− 70, 259)

 FEF25–75c

 

  LS mean change from baseline (SE), mL/s

221 (102)

120 (103)

  LSM difference, BGF versus GFF (95% CI)

101 (− 47, 250)

  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
  5. BGF budesonide/glycopyrrolate/formoterol fumarate, CI confidence interval, FEF25–75 forced expiratory flow 25–75%, 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, LSM least squares mean, SE standard error, siRaw specific image-based airway resistance, siVaw specific image-based airway volume, TLC total lung capacity