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Table 2 Efficacy endpoints (mITT population; efficacy estimand)

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

Change from baseline in morning pre-dose trough FEV1 (mL) over weeks 12–24

 Overall population

  n

592

559

278

288

  LSM (SE)

138 (7.0)

118 (7.1)

61 (9.9)

76 (9.8)

   BGF versus comparators

   LSM difference (95% CI)

–

20 (1, 39)

77 (53, 100)

62 (38, 85)

   p-value

–

0.0424

 < 0.0001

 < 0.0001

 Patients not reversible to albuterol, EOS < 300 cells/mm3

 n

285

277

138

140

 LSM (SE)

97 (9.0)

102 (9.2)

28 (12.8)

46 (12.8)

   BGF versus comparators

   LSM difference (95% CI)

–

–5 (–29, 20)

69 (39, 99)

51 (20, 81)

   p-value

–

0.7041

 < 0.0001

0.0011

Rate of moderate-to-severe exacerbations

 Overall population

  n

639

625

314

318

  Patients with exacerbations, n (%)

108 (16.9)

157 (25.1)

65 (20.7)

61 (19.2)

  Adjusted rate per year

0.46

0.95

0.56

0.55

   BGF versus comparators

   Rate ratio (95% CI)

–

0.48 (0.37, 0.64)

0.82 (0.58, 1.17)

0.83 (0.59, 1.18)

   p-value

–

 < 0.0001

0.2792

0.3120

 Patients not reversible to albuterol, EOS < 300 cells/mm3

  n

319

315

161

153

  Patients with exacerbations, n (%)

56 (17.6)

80 (25.4)

37 (23.0)

39 (25.5)

  Adjusted rate per year

0.46

0.87

0.56

0.68

   BGF versus comparators

   Rate ratio (95% CI)

–

0.53 (0.37, 0.76)

0.81 (0.51, 1.29)

0.67 (0.43, 1.04)

   p-value

–

0.0005

0.3770

0.0756

Rate of severe exacerbations

 Overall population

  n

639

625

314

318

  Patients with exacerbations, n (%)

17 (2.7)

33 (5.3)

9 (2.9)

11 (3.5)

  Adjusted rate per year

0.05

0.13

0.05

0.07

   BGF versus comparators

   Rate ratio (95% CI)

–

0.36 (0.18, 0.70)

0.85 (0.34, 2.13)

0.69 (0.29, 1.61)

   p-value

–

0.0026

0.7363

0.3861

 Patients not reversible to albuterol, EOS < 300 cells/mm3

  n

319

315

161

153

  Patients with exacerbations, n (%)

11 (3.4)

20 (6.3)

7 (4.3)

3 (2.0)

  Adjusted rate per year

0.07

0.18

0.10

0.03

   BGF versus comparators

   Rate ratio (95% CI)

–

0.40 (0.17, 0.94)

0.74 (0.24, 2.30)

2.10 (0.50, 8.81)

   p-value

–

0.0365

0.6057

0.3096

  1. Overall population moderate/severe data from [4]
  2. Treatments were compared adjusting for baseline post-bronchodilator percent predicted FEV1 and baseline eosinophil count as continuous covariates and baseline COPD exacerbations history (0, 1, ≥ 2), country, and ICS use at screening as categorical covariates using negative binomial regression. Time at risk of experiencing an exacerbation was used as an offset variable in the model
  3. BFF, budesonide/formoterol fumarate dihydrate; BGF, budesonide/glycopyrronium/formoterol fumarate dihydrate; BUD/FORM DPI, budesonide/formoterol fumarate dihydrate dry powder inhaler; CI, confidence interval; EOS, blood eosinophil count; FEV1, forced expiratory volume in 1 s; GFF, glycopyrronium/formoterol fumarate dihydrate; LSM, least squares mean; MDI, metered dose inhaler; mITT, modified intent-to-treat; SE, standard error
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Respiratory Research

ISSN: 1465-993X

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