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Table 1 Demographic and baseline disease characteristics (mITT population)

From: Efficacy of budesonide/glycopyrronium/formoterol metered dose inhaler in patients with COPD: post-hoc analysis from the KRONOS study excluding patients with airway reversibility and high eosinophil counts

  BGF
320/14.4/10 µg
GFF
14.4/10 µg
BFF
320/10 µg
BUD/FORM
400/12 µg
Non-reversible and EOS < 300b
(n = 319)
Overall population
(n = 639)
Non-reversible and EOS < 300b
(n = 315)
Overall population
(n = 625)
Non-reversible and EOS < 300b
(n = 161)
Overall population
(n = 314)
Non-reversible and EOS < 300b
(n = 153)
Overall population
(n = 318)
Mean age, years (SD) 65.6 (7.5) 64.9 (7.8) 65.6 (7.6) 65.1 (7.7) 65.3 (7.2) 65.2 (7.2) 66.5 (7.5) 65.9 (7.7)
Male, n (%) 216 (67.7) 460 (72.0) 207 (65.7) 430 (68.8) 108 (67.1) 224 (71.3) 104 (68.0) 236 (74.2)
Mean CAT Score (SD) 18.4 (6.7) 18.7 (6.4) 18.2 (6.4) 18.1 (6.1) 18.5 (6.7) 18.4 (6.6) 17.6 (7.0) 18.0 (6.4)
Mean body mass index, kg/m2 (SD) 25.9 (6.9) 26.1 (6.7) 25.9 (6.5) 26.3 (6.4) 25.4 (5.4) 26.1 (5.8) 25.8 (6.0) 26.2 (6.3)
Current smoker, n (%) 123 (38.6) 256 (40.1) 132 (41.9) 257 (41.1) 61 (37.9) 115 (36.6) 64 (41.8) 122 (38.4)
Median number of pack-years smokeda (range) 45.0
(10–192.5)
45.0
(10.0–256.0)
45.0
(10.0–171.0)
45.0
(10.0–171.0)
47.0
(10.0–192.0)
45.0
(10.0–192.0)
45.8
(10.0–153.0)
45.0
(10.0–180.0)
Median EOS, cells/mm3 (range) 130.0
(10.0–295.0)
150.0
(10.0–2815.0)
140.0
(15.0–295.0)
155.0
(15.0–2490.0)
125.0
(20.0–295.0)
152.5
(15.0–920.0)
140.0
(35.0–295.0)
150.0
(35.0–1100.0)
Exacerbation history, n (%)
 0 239 (74.9) 469 (73.4) 229 (72.7) 473 (75.7) 115 (71.4) 235 (74.8) 111 (72.5) 234 (73.6)
 1 61 (19.1) 125 (19.6) 63 (20.0) 108 (17.3) 37 (23.0) 61 (19.4) 29 (19.0) 59 (18.6)
 ≥ 2 19 (6.0) 45 (7.0) 23 (7.3) 44 (7.0) 9 (5.6) 18 (5.7) 13 (8.5) 25 (7.9)
Post-bronchodilator FEV1% predicted (SD) 48.5 (15.1) 50.2 (14.3) 47.6 (14.3) 50.2 (13.8) 47.5 (14.4) 50.0 (14.0) 48.5 (14.0) 50.7 (13.8)
Mean reversibility, % (SD) 10.1 (8.7) 18.8 (14.4) 9.3 (9.0) 18.1 (14.3) 10.3 (9.4) 19.0 (16.5) 10.6 (8.2) 19.9 (15.1)
Use of ICS at screening, n (%) 220 (69.0) 464 (72.6) 226 (71.7) 447 (71.5) 117 (72.7) 225 (71.7) 107 (69.9) 225 (70.8)
  1. Overall population data from [4]
  2. BFF, budesonide/formoterol fumarate dihydrate; BGF, budesonide/glycopyrronium/formoterol fumarate dihydrate; BUD/FORM DPI, budesonide/formoterol fumarate dihydrate dry powder inhaler; CAT, COPD Assessment Test; COPD, chronic obstructive pulmonary disease; EOS, blood eosinophil count; FEV1, forced expiratory volume in 1 s; GFF, glycopyrronium/formoterol fumarate dihydrate; ICS, inhaled corticosteroid; MDI, metered dose inhaler; mITT, modified intent-to-treat; SD, standard deviation
  3. aNumber of pack years smoked = (number of cigarettes per day / 20) x number of years smoked
  4. bPatients with airways not reversible to albuterol and EOS < 300 cells/mm3