Table 1.
Baseline characteristics in the pooled REACT/RE2SPOND population (ITT population receiving ICS/LABA + LAMA)
| Characteristic | Roflumilast | Placebo |
|---|---|---|
| Baseline characteristics in the pooled REACT/RE2SPOND populationa | ||
| Population number | 1,225 | 1,215 |
| Proportion of patients aged ≤65 years, % | 51.8 | 53.5 |
| Proportion of patients aged ≥65 years, % | 48.2 | 46.7 |
| Proportion of men, % | 70.6 | 68.6 |
| Body mass index, % | ||
| <18.5 kg/m2 | 5.3 | 5.9 |
| 18.5–<25 kg/m2 | 38.9 | 36.3 |
| 25–<30 kg/m2 | 30.9 | 34.1 |
| ≥30 kg/m2 | 24.9 | 23.7 |
| Proportion of current smokers, % | 37.3 | 41.2 |
| Proportion of patients with severe COPD, % | 61.3 | 64.8 |
| Proportion of patients with very severe COPD, % | 37.2 | 33.9 |
| Proportion of patients with ≥1 prior hospitalization, % | 36.2 | 33.3 |
| Baseline characteristics of patients in the pooled REACT/RE2SPOND population with at least one COPD-related hospitalizationb | ||
| Population number | 444 | 405 |
| Proportion of patients aged ≤65 years, % | 52.9 | 56.5 |
| Proportion of patients aged ≥65 years, % | 47.1 | 43.5 |
| Proportion of men, % | 72.7 | 67.2 |
| Body mass index, % | ||
| <18.5 kg/m2 | 5.9 | 5.9 |
| 18.5–<25 kg/m2 | 40.8 | 36.3 |
| 25–<30 kg/m2 | 30.2 | 33.3 |
| ≥30 kg/m2 | 23.2 | 24.4 |
| Proportion of current smokers, % | 44.8 | 48.1 |
| Proportion of patients with severe COPD, % | 56.1 | 60.2 |
| Proportion of patients with very severe COPD, % | 42.3 | 38.8 |
| Proportion of patients with ≥1 prior hospitalization, % | 100 | 100 |
Notes:
a
ITT population receiving ICS/LABA + LAMA.
b
Patients with severe COPD, who had experienced two or more exacerbations and at least one COPD-related hospitalization within the previous year, despite treatment with triple inhaled therapy.
Abbreviations: ICS, inhaled corticosteroid; ITT, intention to treat; LABA, long acting ß2-agonist; LAMA, long-acting muscarinic receptor agonist.