Mean TDI focal score | Difference score (95% CI) | Two-sided p-value | ||
Roflumilast | Placebo | |||
All patients | 0.662 (n=1470) | 0.409 (n=1514) | 0.253 (0.104–0.402) | 0.0009 |
LABA use# | ||||
With LABA | 0.448 (n=718) | 0.159 (n=775) | 0.289 (0.081–0.497) | 0.0066 |
Without LABA | 0.904 (n=752) | 0.680 (n=739) | 0.224 (0.002–0.446) | 0.0477 |
Previous exacerbations# | ||||
Infrequent | 0.604 (n=1070) | 0.451 (n=1105) | 0.153 (-0.026–0.332) | 0.0948 |
Frequent | 0.698 (n=400) | 0.201 (n=409) | 0.497 (0.207–0.786) | 0.0008 |
TDI is graded from 0–4, where 0 is most severe; a change in TDI score of 1.0 unit is considered clinically relevant. Least square means, 95% CI and p-values are based on a repeated measurements ANCOVA model with the following factors and covariates: treatment, baseline value, age, sex, smoking status, time, treatment-by-time interaction, study and country pool (only for the overall population). For all groups apart from LABA usage, concomitant treatment with LABA was also included as a factor. Exacerbations in the previous year (based on patient recall) are defined as infrequent if fewer than two and frequent if two or more exacerbations. #: post hoc analyses.