Skip to main content

Table 2 Efficacy endpoints Least Squares Means full analysis set

From: Efficacy and safety of AZD7594, an inhaled non-steroidal selective glucocorticoid receptor modulator, in patients with asthma: a phase 2a randomized, double blind, placebo-controlled crossover trial

 

Placebo

AZD7594 58μg

AZD7594 250μg

AZD7594 800μg

(n = 52)

(n = 34)

(n = 34)

(n = 34)

Primary efficacy endpoint

Morning pre‐bronchodilator FEV1

Change from baseline (L) on day 15

0.059

0.086

0.136

0.207

Treatment difference (L) (95% CI)

N.A.

0.027 (‐0.086, 0.140)

0.076 (‐0.036, 0.188)

0.148 (0.035, 0.261)

P value

N.A.

0.638

0.183

0.011

Key secondary efficacy endpoints

Morning pre‐bronchodilator FEV1

Change from baseline (L) on day 8

0.071

0.102

0.089

0.227

Treatment difference (L) (95% CI)

N.A.

0.031 (‐0.086, 0.147)

0.017 (‐0.010, 0.134)

0.156 (0.039, 0.273)

P value

N.A.

0.604

0.767

0.009

Key secondary efficacy endpoints

Morning pre‐bronchodilator FEV1

Change from baseline (L) on day 8

0.071

0.102

0.089

0.227

Treatment difference (L) (95% CI)

N.A.

0.031 (‐0.086, 0.147)

0.017 (‐0.010, 0.134)

0.156 (0.039, 0.273)

P value

N.A.

0∙604

0∙767

0∙009

Fraction exhaled nitric oxide (FENO)

Change from baseline (ppb) on day 8

‐4.296

‐9.153

‐14.71

‐19.04

Treatment difference (ppb) (95% CI)

N.A.

‐4.857 (‐11.24, 1.528)

‐10.41 (‐16.75, ‐4.075)

‐14.75 (‐21.18, ‐8.319)

P value

N.A.

0.134

0.002

<0.0001

Change from baseline (ppb) on day 15

‐0.549

‐14.40

‐14.81

‐20.44

Treatment difference (ppb) (95% CI)

N.A.

‐13.85 (‐24.06, ‐3.642)

‐14.26 (‐24.37, ‐4.149)

‐19.90 (‐30.10, ‐9.689)

P value

N.A.

0.008

0.006

0.0002

Morning peak expiratory flow (mPEF)

Change from baseline Day 1‐14

0.0814

10.42

5.334

12.60

Treatment difference (L/min) (95% CI)

N.A.

10.34 (‐1.335, 22.01)

5.253 (‐6.427, 16.93)

12.52 (0.748, 24.29)

P value

N.A.

0.082

0.374

0.037

Evening peak expiratory flow (ePEF)

Change from baseline Day 1‐14

‐8.257

7.475

6.04

11.65

Treatment difference (L/min) (95% CI)

N.A.

15.73 (5.039, 26.43)

14.30 (3.534, 25.06)

19.91 (9.068, 30.75)

P value

N.A.

0.004

0.010

0.0004

Forced vital capacity (FVC)

Change from baseline (L) on day 8

0.0844

0.062

0.084

0.153

Treatment difference (L) (95% CI)

N.A.

‐0.023 (‐0.137, 0.091)

‐0.0003 (‐0.115, 0.114)

0.068 (‐0.046, 0.183)

P value

N.A.

0.694

0.996

0.240

Change from baseline (L) on day 15

0.0765

0.042

0.104

0.138

Treatment difference (L) (95% CI)

N.A.

‐0.035 (‐0.141, 0.072)

0.028 (‐0.078, 0.134)

0.062 (‐0.045, 0.168)

P value

N.A.

0.521

0.598

0.254

Asthma symptom score

Change from baseline day 1 ‐ 14

‐0.012

‐0.119

‐0.094

0.215

Treatment difference (95% CI)

N.A.

‐0.107 (‐0.206, ‐0.008)

‐0.082 (‐0.182, 0.018)

‐0.203(‐0.303, ‐0.103)

P value

N.A.

0.035

0.105

0.0001

Asthma symptom free days

Change from baseline day 1 ‐ 14

0.050

0.603

0.318

1.01

Treatment difference (95% CI)

N.A.

0.553 (0.036, 1.069)

0.268 (‐0.252, 0.788)

0.956 (0.433, 1.48)

P value

N.A.

0.036

0.308

0.0005

Asthma control days

Change from baseline day 1 ‐ 14

0.277

0.950

0.705

1.219

Treatment difference (95% CI)

N.A.

0.673 (0.088, 1.258)

0.428 (‐0.161, 1.017)

0.942 (0.348, 1.535)

P value

N.A.

0.025

0.152

0.002

ACQ‐5 day 15

Change from baseline

0.014

‐0.293

‐0.168

‐0.416

Treatment difference (95% CI)

N.A.

‐0.307 (‐0.516, ‐0.098)

‐0.182 (‐0.393, 0.028)

‐0.430 (‐0.640, ‐0.221)

P value

N.A.

0.004

0.088

<0.0001

Rescue medication use (day 1 – 14)

Change from baseline (inhalations) per day

‐0.334

‐0.678

‐0.819

‐1.137

Treatment difference (95% CI)

N.A.

‐0.344 (‐0.719, 0.0318)

‐0.485 (‐0.863, ‐0.1073)

‐0.803 (‐1.183, ‐0.422)

P value

N.A.

0.072

0.012

<0.0001

Nighttime awakenings

Change from baseline day 1‐ 14

0.007

‐0.412

‐0.173

‐0.760

Treatment difference (95% CI)

N.A.

‐0.419 (‐0.741, ‐0.956)

‐0.179 (‐0.503, 0.144)

‐0.766 (‐1.091, ‐0.441)

P value

N.A.

0.0116

0.273

<0.0001

  1. ACQ‐5 Asthma Control Questionnaire‐5, CI confidence interval, FEV1 forced expiratory volume in 1 second, L liters, ppb parts per billion
Back to article page

Respiratory Research

ISSN: 1465-993X

Contact us