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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