Time to first on-treatment moderate or severe exacerbation by previous treatment, grouped by long-acting bronchodilator (LABD) use
| Placebo | FF 100 µg | VI 25 µg | FF/VI 100/25 µg | |
| Total subjects | 4111 | 4135 | 4118 | 4121 |
| Subjects who did not receive LABD prior to the study | ||||
| None | ||||
| Subjects | 2346 | 2405 | 2326 | 2346 |
| Active versus placebo | ||||
| Hazard ratio (95% CI) | 0.952 (0.852–1.065) | 0.844 (0.752–0.947) | 0.801 (0.713–0.900) | |
| Reduction in risk % (95% CI) | 4.8 (−6.5–14.8) | 15.6 (5.3–24.8) | 19.9 (10.0–28.7) | |
| ICS alone | ||||
| Subjects | 176 | 148 | 169 | 150 |
| Active versus placebo | ||||
| Hazard ratio (95% CI) | 0.889 (0.588–1.344) | 1.180 (0.811–1.717) | 0.877 (0.582–1.322) | |
| Reduction in risk % (95% CI) | 11.1 (−34.4–41.2) | −18.0 (−71.7–18.9) | 12.3 (−32.2–41.8) | |
| Subjects who did receive LABD prior to the study | ||||
| LABD alone | ||||
| Subjects | 464 | 406 | 449 | 415 |
| Active versus placebo | ||||
| Hazard ratio (95% CI) | 0.975 (0.772–1.230) | 0.877 (0.697–1.103) | 0.773 (0.609–0.981) | |
| Reduction in risk % (95% CI) | 2.5 (−23.0–22.8) | 12.3 (−10.3–30.3) | 22.7 (1.9–39.1) | |
| ICS/LABD | ||||
| Subjects | 1102 | 1164 | 1157 | 1194 |
| Active versus placebo | ||||
| Hazard ratio (95% CI) | 1.006 (0.877–1.154) | 0.987 (0.861–1.132) | 0.766 (0.665–0.882) | |
| Reduction in risk % (95% CI) | −0.6 (−15.4–12.3) | 1.3 (−13.2–13.9) | 23.4 (11.8–33.5) |
FF: fluticasone furoate; VI: vilanterol; ICS: inhaled corticosteroid.