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Table 1 Demographic and clinical characteristics: EOS count 100 to < 300 cells/mm3 by exacerbation history, mITT population

From: Benefits of budesonide/glycopyrronium/formoterol fumarate dihydrate on lung function and exacerbations of COPD: a post-hoc analysis of the KRONOS study by blood eosinophil level and exacerbation history

 

BGF

320/14.4/10 µg

GFF

14.4/10 µg

BFF

320/10 µg

EOS 100 to < 300 cells/mm3 – without exacerbation history in the preceding 12 months

N = 308

N = 307

N = 147

 Mean (SD) age, yearsa

65.2 (7.9)

64.9 (7.8)

66.0 (7.1)

 Sex, male n (%)

207 (67.2)

204 (66.4)

110 (74.8)

 EOS count

   

  Median (range) cells per mm3

170.0

(100.0–295.0)

165.0

(100.0–295.0)

175.0

(100.0–295.0)

  ≥ 150 cells/mm3, n (%)

190 (61.7)

188 (61.2)

100 (68.0)

 Current smoker, n (%)

136 (44.2)

129 (42.0)

56 (38.1)

 Mean (SD) number of pack-years smokedb

56.6 (32.4)

51.2 (27.0)

51.4 (26.4)

 Mean (SD) post-salbutamol FEV1, % predicted

51.1 (13.8)

51.6 (13.6)

50.5 (13.5)

 Moderate or severe COPD exacerbations in the past 12 months, n (%)

   

  0

308 (100)

307 (100)

147 (100)

  1

0

0

0

  ≥ 2

0

0

0

 Used ICS at screening, n (%)

207 (67.2)

206 (67.1)

102 (69.4)

 COPD severity, n (%)

   

  Mild

0

0

1 (0.7)

  Moderate

157 (51.0)

166 (54.1)

70 (47.6)

  Severe

131 (42.5)

121 (39.4)

70 (47.6)

  Very severe

20 (6.5)

20 (6.5)

6 (4.1)

 Mean (SD) total CAT scorec

18.7 (6.6)

18.3 (6.2)

18.6 (6.8)

 Reversibilityd, n (%)

137 (44.5)

136 (44.3)

66 (44.9)

EOS 100 to < 300 cells/mm3– with exacerbation history in the preceding 12 months

N = 102

N = 92

N = 45

     Mean (SD) age, yearsa

62.9 (8.7)

64.8 (8.0)

62.8 (7.2)

     Sex, n (%) male

67 (65.7)

56 (60.9)

26 (57.8)

     EOS count

   

          Median (range) cells per mm3

165.8

(100.0–295.0)

165.0

(105.0–295.0)

150.0

(100.0–290.0)

          ≥ 150 cells/mm3, n (%)

63 (61.8)

61 (66.3)

23 (51.1)

     Current smoker, n (%)

42 (41.2)

39 (42.4)

21 (46.7)

     Mean (SD) number of pack-years smokedb

48.5 (25.7)

49.8 (25.8)

56.0 (36.0)

     Mean (SD) post-salbutamol FEV1, % predicted

49.3 (13.2)

47.7 (14.3)

49.1 (16.1)

     Moderate or severe COPD exacerbations in the past 12 months, n (%)

   

          0

0

0

0

          1

77 (75.5)

67 (72.8)

34 (75.6)

          ≥ 2

25 (24.5)

25 (27.2)

11 (24.4)

     Used ICS at screening, n (%)

76 (74.5)

67 (72.8)

36 (80.0)

     COPD severity, n (%)

   

          Mild

1 (1.0)

0

0

          Moderate

44 (43.1)

38 (41.3)

20 (44.4)

          Severe

51 (50.0)

42 (45.7)

19 (42.2)

          Very severe

6 (5.9)

12 (13.0)

6 (13.3)

     Mean (SD) total CAT scorec

19.5 (6.3)

18.5 (6.5)

19.3 (6.2)

     Reversibilityd, n (%)

50 (49.0)

26 (28.3)

20 (44.4)

  1. aAge is the age at the time of informed consent
  2. b(Number of cigarettes per day / 20) × number of years smoked
  3. cThe total score is the sum of eight CAT item scores
  4. dReversibility defined as improvement in FEV1 after salbutamol administration (compared with before salbutamol administration) of 12% or more and 200 mL or more
  5. Abbreviations. BFF: budesonide/formoterol fumarate dihydrate; BGF: budesonide/glycopyrronium/formoterol fumarate dihydrate; CAT: COPD Assessment Test; COPD: chronic obstructive pulmonary disease; EOS: eosinophil; FEV1: forced expiratory volume in 1 s; GFF: glycopyrronium/formoterol fumarate dihydrate; ICS: inhaled corticosteroid; mITT: modified intention-to-treat; SD: standard deviation