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Table 2 Spirometry endpoints: Day 1 and Day 14 (mITT population)

From: Dose-response to inhaled glycopyrrolate delivered with a novel Co-Suspension™ Delivery Technology metered dose inhaler (MDI) in patients with moderate-to-severe COPD

 

GP MDI

Placebo

Open-label tiotropium

18 μg

9 μg

4.6 μg

2.4 μg

1.2 μg

0.6 μg

Primary endpoint: change from baseline in FEV1 AUC0–12, mL: Day 14

n

58

58

59

60

53

54

52

55

LSM

159

127

143

127

97***

64*

1

225

95 % CI

116, 202

84, 170

100, 185

85, 169

52, 141

20, 108

−43, 46

182, 269

Change from baseline in morning pre-dose trough FEV1, mL: Day 14

n

58

59

60

59

55

55

56

57

LSM

89***

80***

67**

77**

68**

29

−8

126

95 % CI

47, 132

38, 122

26, 109

35, 118

25, 111

−14, 72

−50, 35

84, 168

Change from baseline in evening 12-h post-dose trough FEV1, mL: Day 14

n

58

58

59

60

53

55

54

56

LSM

116

69*

99***

112

66*

55

1

164

95 % CI

69, 163

22, 117

52, 145

65, 158

17, 115

7, 104

−48, 49

116, 211

Change from baseline in morning pre-dose trough inspiratory capacity, mL: Day 14

n

58

59

60

60

55

54

56

56

LSM

94*

45

64

104*

69

34

9

138**

95 % CI

32, 156

−16, 106

3, 124

43, 165

6, 132

−30, 97

−54, 71

76, 201

Peak change from baseline in FEV1, mL: Day 1

n

59

59

60

59

55

55

60

57

LSM

231

226

165

170

136**

107

57

270

95 % CI

191, 272

186, 267

125, 205

130, 211

95, 177

65, 149

17, 97

229, 311

Peak change from baseline in FEV1, mL: Day 14

n

58

59

60

60

54

54

54

57

LSM

288

288

287

261

246***

188

130

361

95 % CI

236, 339

237, 340

236, 338

210, 312

193, 299

135, 241

77, 183

309, 413

Peak change from baseline in inspiratory capacity, mL: Day 1

n

59

59

61

60

55

54

60

56

LSM

234***

263

151

183*

126

82

80

343

95 % CI

163, 304

193, 333

82, 219

113, 252

54, 198

9, 155

10, 150

271, 414

Peak change from baseline in inspiratory capacity, mL: Day 14

n

58

59

60

60

54

54

56

56

LSM

280

259***

288

226**

261***

172

77

284

95 % CI

197, 363

177, 341

206, 370

145, 308

176, 346

87, 256

−6, 161

200, 368

  1. Adjusted difference versus placebo: *p < 0.05; **p < 0.01; ***p < 0.001; p < 0.0001
  2. AUC0–12 area under the curve from 0 to 12 h; CI confidence interval; FEV 1 forced expiratory volume in 1 s; GP glycopyrrolate; LSM least squares mean; MDI metered dose inhaler; mITT modified intent-to-treat