Table 3.
Outcome means by average ΔFEV1 category, P values for associations between average ΔFEV1 and outcome, and correlations at individual and cohort levels
| Average ΔFEV1 (ml) | Category midpoint value of ΔFEV1 (ml) | Withdrawal rate* (% patients) | TDI at 12 weeks (n = 2781) | TDI at 24/26 weeks (n = 2208) | TDI at 52 weeks (n = 1099) | ΔSGRQ at 12 weeks (n = 3141) | ΔSGRQ at 24/26 weeks (n = 2215) | ΔSGRQ at 52 weeks (n = 1115) | Rescue medication mean puffs per day (over study duration) (n = 3158) | Exacerbation rate (per year) (n = 3158) | Severe exacerbation rate (per year) (n = 3158) |
|---|---|---|---|---|---|---|---|---|---|---|---|
| -500, -50 | -275 | 11.2 | 1.44 | 1.57 | 1.24 | -3.15 | -4.70 | -2.21 | 2.46 | 0.63 | 0.059 |
| -50, 50 | 0 | 9.0 | 1.31 | 1.39 | 1.92 | -3.17 | -3.81 | -3.03 | 2.57 | 0.58 | 0.065 |
| 50, 150 | 100 | 10.1 | 1.79 | 1.97 | 1.65 | -3.84 | -4.74 | -4.22 | 2.10 | 0.61 | 0.057 |
| 150, 250 | 200 | 10.2 | 2.12 | 2.23 | 2.23 | -5.84 | -6.34 | -6.70 | 1.80 | 0.51 | 0.048 |
| 250, 500 | 375 | 6.7 | 2.68 | 3.03 | 3.27 | -7.38 | -7.29 | -9.06 | 1.66 | 0.38 | 0.021 |
| P value (Kruskal-Wallis) | < 0.001 | < 0.001 | < 0.001 | < 0.001 | < 0.001 | < 0.001 | < 0.001 | < 0.001 | 0.1 | ||
| Correlation, individual level | 0.15 | 0.14 | 0.18 | -0.12 | -0.07 | -0.16 | -0.11 | -0.06 | -0.03 | ||
| Correlation, cohort level | 0.90 | 0.88 | 0.92 | -0.90 | -0.79 | -0.95 | -0.88 | -0.89 | -0.81 | ||
*Non-completers in all studies categorised by ΔFEV1 at Day 2; ΔFEV1, change from baseline in trough forced expiratory volume in 1 second; TDI, Transition Dyspnoea Index; ΔSGRQ, change from baseline in St George's Respiratory Questionnaire