Bronchiectasis group trial end-points
Exacerbation end-points | HFNT | Control | Rate ratio (95% CI) | p-value |
Rate, number per patient per year | 2.39 | 3.48 | 0.69 (0.49, 0.97) | 0.034 |
Annual exacerbation days (geometric mean) | 10.3 | 29.9 | 0.32 (0.14, 1.02) | 0.056 |
Days to first exacerbation (predicted median) | 84 | 54 | 0.70# (0.35, 1.40) | 0.316 |
Secondary end-points | Change from baseline | Difference (95% CI) | p-value | |
HFNT | Control | |||
FEV1 L | 0.145 | 0.035 | 0.11 (−0.037, 0.257) | 0.139 |
FVC L | 0.115 | −0.104 | 0.22 (−0.031, 0.468) | 0.084 |
St George's respiratory questionnaire score¶ | ||||
Total | −12.3 | −1.2 | −11.0 (−20.7, −1.3) | 0.028 |
Symptoms | −16.9 | −9.8 | −7.1 (−21.0, 6.8) | 0.308 |
Activity | −6.3 | 3.3 | −9.6 (−20.7, 1.5) | 0.087 |
Impacts | −14.7 | −1.6 | −13.1 (−23.7, −2.4) | 0.018 |
6-minute walk distance m | −16.2 | −33.3 | −17.1 (−62.3, 28.1) | 0.445 |
HFNT: high-flow nasal therapy; FEV1: forced expiratory volume in 1 s; FVC: forced vital capacity. #: hazard ratio; ¶: scores range from 0 to 100, with low scores indicating improvement; a change of four or more units is deemed clinically meaningful.