Table 2.
Patient Characteristics in the TRILOGY, KRONOS, FULFIL, TRIBUTE, ETHOS, and IMPACT Trials
| Baseline Characteristics (at Study Entry) | TRILOGY25 | KRONOS20 | FULFIL21,87a | TRIBUTE23b | ETHOS24,90 | IMPACT22 |
|---|---|---|---|---|---|---|
| Sex | ||||||
| Female | 24% | 29% | 26% | 28% | 40% | 34% |
| Male | 76% | 71% | 74% | 72% | 60% | 66% |
| Ethnicity | ||||||
| White | >99% | 50% | 85% | 92%c | 85%b | 78% |
| Other | <1% | 50% | 15% | 7%c | 15%b | 22% |
| Age, mean (years) | 63.3–63.8 | 64.9–65.9 | 63.9 | 64.4–64.5 | 64.6–64.8 | 65.3 |
| BMI, mean (kg/m2) | 26.3–26.4 | 26.1–26.3 | 26.9 | 25.7–26.6 | 27.5b | 26.6 |
| GOLD classification | ||||||
| GOLD B | 0% | NR | 46% | NR | NR | 30% |
| GOLD D | 100% | NR | 54% | NR | NR | 70% |
| FEV1, % predictedd | ||||||
| Mean | 36.2–36.9 | 50.0–50.7 | 45.3% | 36.4 | 43.1–43.6 | 45.5 |
| ≥80% | 0% | NR (inclusion criteria: <80%) | <1% | 0% | 0% | <1% |
| 50% to <80% | 0% | NR | 33% | 0% | 29% | 36% |
| 30% to <50% | 77% | NR | 54% | 80% | 60% | 48% |
| <30% | 23% | NR | 13% | 20% | 11% | 16% |
| CAT score, mean | 20.8 | 18.0–18.7 | 19.1 | NR (inclusion criteria: ≥10) | 19.5–19.7 | 20.1 |
| Moderate/severe exacerbations in the preceding year | ||||||
| 0 | NR (inclusion criteria: ≥1) | 74% | 35% | 0% | <1% | <1% |
| 1 | NR | 19% | 28% | 81% | 43% | 45% |
| ≥2 | NR | 7% | 37% | 19% | 57% | 55% |
| Raw calculated annual rate | 1.2 | 0.3–0.4 | NR | 1.2 | 1.7 | NR |
| Prior ICS use | ||||||
| ICS at study entry (alone or as any combination) | 74% | 72% | 66% | 66% | 80% | 71% |
| Triple therapy (ICS/LABA/LAMA) | 0% | 27%a | 28% | 0% | 39%b | 38% |
Notes: Unless otherwise indicated, data are % of patients in the intention-to-treat population. Mean values are given as a range over the treatment arms when data for the overall population were not provided. aData presented for the ITT population (24 weeks); bdata presented are for the safety population; cdata missing for a total of 16 patients in the study; dpost-salbutamol administration.
Abbreviations: BMI, body mass index; CAT, COPD Assessment Test; COPD, chronic obstructive pulmonary disease; FEV1, forced expiratory volume in 1 second; GOLD, Global Initiative for Chronic Obstructive Lung Disease; ICS, inhaled corticosteroid; LABA, long-acting β2-agonist; LAMA, long-acting muscarinic antagonist; NR, not reported.