Table 3.
Secondary Outcomes – Mean change from Baseline
| P-values | |||||
|---|---|---|---|---|---|
| Placebo | Esomeprazole | Treatment effect | Plb vs Eso* | GER Interaction† | |
| N Mean Change Baseline to 24 weeks (95% confidence interval) | |||||
| Lung function | |||||
| pre-BD FEV1 (L) | 191 −0.02 −.06, 0.01 |
201 0.00 −0.04, 0.04 |
0.03 −0.03, 0.08 |
0.36 | 0.56 |
| pre-BD FVC (L) | 191 −0.03 −0.06, 0.01 |
201 0.00 −0.04, 0.05 |
0.03 −0.03, 0.09 |
0.30 | 0.77 |
| FEV1 change with BD (%) | 191 −0.2 −1.6, 0.1 |
201 −1.3 −3.4, 0.7 |
−1.0 −3.5, 1.4 |
0.41 | 0.45 |
| Peak flow rate (L/min) | 191 3.2 −3.5, 9.9 |
201 9.2 1.8, 16.6 |
6.0 −3.9, 16.0 |
0.24 | 0.03 |
| PC20 Methacholine (mg/mL)‡ | 40 1.5 0.2, 2.8 |
33 −0.3 −1.4, 1.6 |
−1.8 −3.6, −0.1 |
0.04 | 0.68 |
| PC20 not achieved at 24-weeks n (%) | 18 (31) | 20 (35) | 4% | 0.60 | |
| Asthma control scores and Mini-Asthma Quality of Life | |||||
| Asthma control score | 191 −0.3 −0.4, −0.2 |
201 −0.2 −0.3, −0.1 |
0.1 0.0,0.2 |
0.11 | 0.73 |
| ASUI | 191 0.05 0.03, 0.07 |
201 0.02 0.01, 0.04 |
−0.02 −0.05, 0.05 |
0.11 | 0.75 |
| Mini Asthma Quality of life score | 191 0.3 0.2, 0.4 |
201 0.3 0.2, 0.4 |
−0.1 −0.2, 0.1 |
0.33 | 0.81 |
| Quality of Life - SF36 score | |||||
| Mental | 191 0.0 −1.1, 1.1 |
201 0.4 −0.6, 1.4 |
0.5 −1.1, 2.0 |
0.56 | 0.46 |
| Physical | 191 2.0 1.1, 2.9 |
201 1.1 0.3, 1.9 |
−0.9 −2.1, 0.4 |
0.16 | 0.58 |
| Gastric Symptoms | |||||
| GSAS score | 191 −0.17 −0.21, −0.12 |
201 −0.16 −0.20, −0.11 |
0.01 −0.05, 0.07 |
0.76 | 0.99 |
| Number of symptoms | 191 −1.7 −2.1, −1.3 |
201 −1.9 −2.3, −1.6 |
−0.2 −0.8, 0.3 | 0.40 | 0.91 |
*
P-value for treatment effect (Esomeprazole - Placebo) estimated by linear regression
†
P-value for modification of treatment effect by pH probe results estimated by linear regression; the number of participants with pH probe data available was 302.
‡
Adjusted for baseline value
Abbreviations: BD - bronchodilator; ASUI - Asthma Symptom Utility Index; GSAS -Gastroesophageal Reflux Disease Symptom Assessment Scale