Skip to main content

Table 3 Pooled analysis of IC response on day 29 (mITT population)

From: 24-h bronchodilation and inspiratory capacity improvements with glycopyrrolate/formoterol fumarate via co-suspension delivery technology in COPD

 

Response in peak IC

Treatment versus comparator, OR (95% CI)

GFF MDI

18/9.6 μg

n = 102

Placebo

MDI

n = 99

TIO SMI

5 μg

n = 68

GFF MDI vs placebo MDI

GFF MDI vs TIO SMI

TIO SMI vs placebo MDI

Patients achieving a response (evening), %

  > 10%

83.5

31.5

71.1

11.00 (4.12–29.43)

2.05 (0.83–5.10)

5.36 (2.13–13.49)

  > 15%

72.1

19.0

47.0

10.98 (4.34–27.79)

2.91 (1.27–6.68)

3.77 (1.58–8.98)

  > 20%

54.8

15.3

31.4

6.70 (2.98–15.08)

2.65 (1.27–5.51)

2.53 (1.12–5.74)

  > 200 mL

83.1

27.8

61.3

12.78 (4.70–34.79)

3.12 (1.25–7.79)

4.10 (1.68–9.99)

  > 300 mL

66.3

20.0

43.4

7.84 (3.47–17.74)

2.56 (1.22–5.37)

3.06 (1.38–6.79)

  > 400 mL

46.5

10.3

20.9

7.58 (3.09–18.63)

3.29 (1.42–7.61)

2.31 (0.89–5.96)

Patients achieving a response (morning), %

  > 10%

92.1

47.2

75.2

12.94 (4.57–36.68)

3.82 (1.38–10.57)

3.39 (1.39–8.30)

  > 15%

81.4

30.1

65.5

10.16 (4.11–25.14)

2.31 (0.98–5.46)

4.39 (1.85–10.44)

  > 20%

75.6

12.5

46.8

21.72 (6.58–71.65)

3.53 (1.32–9.47)

6.15 (2.06–18.35)

  > 200 mL

89.5

40.7

72.8

12.37 (4.82–31.78)

3.17 (1.27–7.94)

3.90 (1.70–8.95)

  > 300 mL

79.1

23.6

67.4

12.24 (4.62–32.47)

1.83 (0.75–4.45)

6.69 (2.51–17.80)

  > 400 mL

67.9

13.3

34.0

13.84 (5.24–36.54)

4.12 (1.77–9.60)

3.36 (1.33–8.51)

  1. CI confidence interval, GFF glycopyrrolate/formoterol fumarate, IC inspiratory capacity, MDI metered dose inhaler, mITT modified intent-to-treat, OR odds ratio, SMI Soft Mist™ inhaler, TIO open-label tiotropium