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Table 3 Secondary efficacy endpoints: Days 1 and 7 – GFF MDI 72/9.6 μg and GFF MDI 36/9.6 μg comparisons (mITT population)

From: A randomized, seven-day study to assess the efficacy and safety of a glycopyrrolate/formoterol fumarate fixed-dose combination metered dose inhaler using novel Co-Suspension™ Delivery Technology in patients with moderate-to-very severe chronic obstructive pulmonary disease

Comparator

Treatment differences for GFF MDI comparisons

GP MDI 36 μg

Open-label tiotropium 18 μg

FF MDI

Placebo MDI

Open-label FFa DPI 12 μg

9.6 μg

7.2 μg

DAY 7

Change from baseline in morning pre-dose trough FEV1, L

GFF MDI 72/9.6 μg

 LSMb difference (SE)

0.0960 (0.0280)***

0.096 (0.0247)

0.129 (0.0278)

0.120 (0.0271)

0.234 (0.0302)

0.091 (0.0277)**

GFF MDI 36/9.6 μg

LSMb difference (SE)

0.073 (0.0273)**

0.073 (0.0245)**

0.106 (0.0274)

0.097 (0.0270)***

0.211 (0.0300)

0.068 (0.0275)*

Peak change from baseline in FEV1, L

GFF MDI 72/9.6 μg

 LSMb difference (SE)

0.125 (0.0282)

0.140 (0.0248)

0.101 (0.0279)***

0.108 (0.0271)

0.342 (0.0300)

0.082 (0.0278)**

GFF MDI 36/9.6 μg

 LSMb difference (SE)

0.127 (0.0273)

0.141 (0.0245)

0.103 (0.0273)***

0.110 (0.0268)

0.344 (0.0298)

0.083 (0.0276)**

Change from baseline in morning pre-dose trough IC, L

GFF MDI 72/9.6 μg

 LSMb difference (SE)

0.083 (0.0445)

0.090 (0.0399)*

0.156 (0.0452)***

0.110 (0.0436)*

0.255 (0.0483)

0.096 (0.0447)*

GFF MDI 36/9.6 μg

 LSMb difference (SE)

0.098 (0.0445)*

0.105 (0.0387)**

0.172 (0.0433)

0.126 (0.0428)**

0.271 (0.0471)

0.111 (0.0434)*

Peak change from baseline in IC, L

GFF MDI 72/9.6 μg

 LSMb difference (SE)

0.078 (0.0532)

0.095 (0.0470)*

0.050 (0.0529)

0.033 (0.0513)

0.265 (0.0572)

0.016 (0.0527)

GFF MDI 36/9.6 μg

 LSMb difference (SE)

0.107 (0.0513)*

0.124 (0.0461)**

0.078 (0.0513)

0.062 (0.0503)

0.293 (0.0559)

0.045 (0.0518)

DAY 1

Peak change from baseline in FEV1, L

GFF MDI 72/9.6 μg

 LSMb difference (SE)

0.081 (0.0309)**

0.104 (0.0268)

0.062 (0.0307)*

0.060 (0.0297)*

0.265 (0.0328)

0.072 (0.0306)*

GFF MDI 36/9.6 μg

 LSMb difference (SE)

0.068 (0.300)*

0.090 (0.0266)***

0.048 (0.0300)

0.046 (0.0293)

0.251 (0.0326)

0.058 (0.0303)

Peak change from baseline in IC, L

GFF MDI 72/9.6 μg

 LSMb difference (SE)

0.065 (0.0567)

0.149 (0.0493)**

0.134 (0.0564)*

0.144 (0.0547)**

0.412 (0.0607)

0.121 (0.0561)*

GFF MDI 36/9.6 μg

 LSMb difference (SE)

−0.019 (0.0555)

0.065 (0.0491)

0.050 (0.0554)

0.060 (0.0542)

0.328 (0.0602)

0.037 (0.0557)

Time to onset of action, hazard ratioc

GFF MDI 72/9.6 μg

 HR

1.399*

1.754***

0.980

1.150

3.475

0.971

 95% CI

1.038, 1.884

1.300, 2.367

0.746, 1.289

0.904, 1.465

2.095, 5.765

0.713, 1.321

GFF MDI 36/9.6 μg

 HR

1.323

1.695***

0.888

1.062

3.358

0.878

 95% CI

0.936, 1.870

1.275, 2.253

0.671, 1.175

0.0806, 1.400

2.091, 5.391

0.660, 1.169

  1. * p < 0.05; ** p < 0.01; *** p < 0.001; p ≤ 0.0001
  2. aForadil® Aerolizer®; bLSM allows for any imbalances in baseline covariates that relate to responses to be adjusted for in order to avoid bias in treatment effect estimates; ca hazard ratio of 1.399 signifies a 39.9% higher probability of onset of action at any time point post-dose
  3. CI confidence interval, DPI dry powder inhaler, FEV 1 forced expiratory volume in 1 s, FF formoterol fumarate, GFF glycopyrrolate/formoterol fumarate, GP glycopyrrolate, HR hazard ratio, IC inspiratory capacity, LSM least squares mean, MDI metered dose inhaler, mITT modified intent-to-treat, SE standard error