Budesonide/formoterol as effective as prednisolone plus formoterol in acute exacerbations of COPD A double-blind, randomised, non-inferiority, parallel-group, multicentre study

Table 1 Patient baseline demographics and characteristics

	Budesonide/formoterol N = 55	Prednisolone + formoterol N = 54
Age, years	67.2 (9.7)	66.7 (9.3)
Females, %	55%	43%
Time since COPD diagnosis, years	8.0 (5.7)	5.9 (4.3)
Current smokers, %	33%	28%
Pack-years (range)	33 (10–120)	33 (10–83)
Body mass index	25.2 (4.8)	26.0 (5.3)
*FEV, L**	1.16 (0.34)	1.23 (0.37)
FEV ₁ *, % predicted normal	45.1 (8.9)	45.0 (9.5)
*FVC, L**	2.42 (0.73)	2.48 (0.70)
FEV ₁ */FVC ratio**	0.49 (0.12)	0.51 (0.11)
GOLD classification (no. of patients)
I	1	1
IIa	28	33
IIb	26	18
III	0	2
SpO ₂	95.2 (1.7)	94.9 (1.6)
Maintenance medication at study entry ^† :
ICS + LABA + AC	24	20
ICS + LABA	10	9
ICS + AC	1	5
AC ± SABA/LABA	14	7
No medication	6	13
Mean dose of ICS, ^‡ μg/day	659 (267)	553 (241)

Data are presented as means and standard deviations. * Lung function measurements were performed 0.25–4 hours (mean 0.9 hours) after acute therapy; ^† ICS = inhaled corticosteroid; LABA = long-acting inhaled β₂-agonist; AC = anticholinergics, SABA = short-acting inhaled β₂-agonist; ^‡ Mean ICS intake in patients with recorded ICS use.

ISSN: 1465-993X