Table 1 Exacerbation data by treatment group and ICS users/non-users in RESTORE study [95, 101]

Exacerbation rate, per patient per year

All RESTORE patients (N = 445)

N = 215

 N = 230

All patients

0.91

1.13

-19.4

0.01

ICS users^a (N = 338)

0.93

1.16

-19.5

0.02

ICS non-users (N = 107)

0.89

1.10

-19.3

0.01

Moderate COPD subgroup (N = 254)

N = 126

 N = 128

All patients in subgroup

0.27

0.51

−47.2

0.003

ICS users^a (N = 135)

0.30

0.54

−44.4

0.002

ICS non-users (N = 119)

0.26

0.49

−46.9

0.003

Time to first exacerbation in days, mean (SD)

RESTORE patients ^c (N = 224)

171 (27)

164 (28)

+ 3.6

0.020

ICS users (N = 63)

173 (29)

166 (27)

+ 4.0

0.028

ICS non-users (N = 161)

171 (24)

165 (28)

+ 3.5

0.048

Moderate COPD subgroup (N = 163)

182 (19)

169 (25)

+ 7.7

< 0.001

ICS users (N = 30)

180 (23)

168 (24)

+ 7.1

< 0.001

ICS non-users (N = 133)

185 (18)

170 (23)

+ 8.8

< 0.001

Exacerbation duration in days, mean (SD)

All RESTORE patients (N = 445)

All exacerbations

9.5 (7.2)

12.6 (9.7)

-24.6 (5.3)

0.023

Mild exacerbations

8.4 (5.2)

10.4 (8.2)

-19.2 (4.9)

0.039

Moderate-to-severe exacerbations

11.1 (8.9)

14.1 (10.8)

-21.3 (5.2)

0.041

Moderate COPD subgroup (N = 254)

All exacerbations

9.1 (7.4)

12.3 (9.6)

−26.0 (5.6)

0.022

Mild exacerbations

7.7 (4.9)

9.8 (8.0)

−21.4 (5.0)

0.037

Moderate-to-severe exacerbations

10.5 (8.5)

13.7 (10.4)

−23.4 (4.8)

0.040

ICS users (N = 135)

All exacerbations

9.3 (7.7)

12.5 (9.8)

−22.4 (5.9)

0.041

Mild exacerbations

7.9 (5.9)

10.1 (8.3)

−21.8 (5.2)

0.028

Moderate-to-severe exacerbations

10.9 (9.2)

14.0 (11.8)

−22.1 (4.8)

0.049

ICS non-users (N = 119)

All exacerbations

9.0 (7.3)

12.1 (9.8)

−25.6 (5.4)

0.019

Mild exacerbations

7.8 (5.4)

9.7 (8.1)

−19.6 (5.1)

0.048

Moderate-to-severe exacerbations

10.7 (8.8)

13.9 (9.8)

−23.0 (5.0)

0.043