Skip to main content

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