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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