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Table 1 Baseline demographics and characteristics (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)
Total
(N = 23)
Mean age, years (SD) 64.8 (7.8) 64.9 (7.6) 64.9 (7.6)
Male, n (%) 17 (77.3) 18 (78.3) 18 (78.3)
Current smoker, n (%) 10 (45.5) 10 (43.5) 10 (43.5)
 Median pack-years smoked, (range) 40.5 (15–100) 41.0 (15–100) 41.0 (15–100)
Severity of COPD (GOLD), n (%)    
 Moderate 17 (77.0) 17 (73.9) 17 (73.9)
 Severea 5 (22.7) 6 (26.1) 6 (26.1)
COPD exacerbations per patient (past 12 months), mean (SD) 0.2 (0.5) 0.2 (0.5) 0.2 (0.5)
Total CAT score (0–40)b, mean (SD) 17.6 (5.5) 17.3 (5.6) 17.3 (5.6)
FEV1 at Visit 1 (% predicted)    
 Pre-bronchodilator, mean (SD) 58.9 (13.3) 58.4 (13.1) 58.4 (13.1)
 Post-bronchodilator, mean (SD) 64.1 (13.7) 63.6 (13.7) 63.6 (13.7)
 FEV1/FRC post-bronchodilator at Visit 1, mean (SD) 52.0 (10.6) 51.7 (10.5) 51.7 (10.5)
% predicted RV, mean (SD) 173.7 (44.9) 173.2 (43.9) 173.2 (43.9)
TLC (L), mean (SD) 7.5 (1.5) 7.4 (1.4) 7.4 (1.4)
% predicted FRC, mean (SD) 150.4 (26.6) 149.8 (26.2) 149.8 (26.2)
  1. aOne patient was reported with very severe COPD on the electronic case report form; however, all FEV1 values at Visit 1 and Visit 3 fell within the inclusion criteria (30–< 80%) and the patient was correctly randomized as having severe COPD
  2. bThe total score was the sum of 8 CAT item scores. A higher scored denotes more severe impact of COPD
  3. BGF budesonide/glycopyrrolate/formoterol fumarate; CAT COPD Assessment Test; COPD chronic obstructive pulmonary disease; FEV1 forced expiratory volume in 1 s; FRC functional residual capacity; GFF glycopyrrolate/formoterol fumarate; GOLD The Global Initiative for Chronic Obstructive Lung Disease; ITT intent-to-treat; RV residual volume; SD standard deviation; TLC total lung capacity