Table 2.
Summary of Results for Primary and Selected Secondary Endpoints at 52 Weeks
| Endpoints | Items | Statistics | HFNC/LTOT (n = 47) |
n | LTOT (n = 46) |
n | P Values |
|---|---|---|---|---|---|---|---|
| Primary | COPD exacerbation rate (moderate/severe) | Ratio of the mean count (95% CI) | Reference level | 2.85 (1.48–5.47) | 0.002 | ||
| Unadjusted mean count (SD) | 1.0 (1.8) | 2.5 (3.8) | |||||
| Secondary | COPD exacerbation rate (severe) | Ratio of the mean count (95% CI) | Reference level | 1.54 (0.74–3.22) | 0.250 | ||
| Unadjusted mean count (SD) | 0.3 (0.5) | 0.5 (0.9) | |||||
| COPD exacerbation rate (all) | Ratio of the mean count (95% CI) | Reference level | 1.40 (0.91–2.16) | 0.126 | |||
| Unadjusted mean count (SD) | 3.8 (4.0) | 5.3 (4.4) | |||||
| Modified MRC scale score at 52 wk | Count | Grade 0 | 0 | Grade 0 | 0 | 0.922 | |
| Grade 1 | 2 | Grade 1 | 3 | ||||
| Grade 2 | 10 | Grade 2 | 9 | ||||
| Grade 3 | 17 | Grade 3 | 21 | ||||
| Grade 4 | 7 | Grade 4 | 7 | ||||
| SpO2, %* | LSM (SE) | 1.01 ± 0.33% | 37 | −0.20 ± 0.32% | 40 | 0.010 | |
| pH† | Sample mean (SD) | 7.38 (0.03) | 37 | 7.38 (0.04) | 38 | 0.118 | |
| Difference‡ | 0.00 (0.03) | 37 | −0.01 (0.03) | 38 | |||
| PaCO2† | Sample mean (SD) | 50.87 (8.28) | 37 | 51.65 (8.57) | 38 | 0.520 | |
| Difference‡ | 0.54 (7.23) | 37 | 1.54 (6.13) | 38 | |||
| PaO2† | Sample mean (SD) | 84.82 (23.36) | 37 | 77.37 (14.53) | 38 | 0.063 | |
| Difference‡ | 4.21 (26.51) | 37 | −7.04 (24.94) | 38 | |||
| VC† | Sample mean (SD) | 2.24 (0.50) | 36 | 2.27 (0.61) | 39 | 0.351 | |
| Difference‡ | −0.04 (0.27) | 35 | 0.03 (0.33) | 36 | |||
| FVC† | Sample mean (SD) | 2.05 (0.56) | 36 | 2.07 (0.63) | 39 | 0.888 | |
| Difference‡ | −0.02 (0.31) | 35 | −0.03 (0.33) | 38 | |||
| FEV1† | Sample mean (SD) | 0.66 (0.25) | 36 | 0.65 (0.21) | 39 | 0.265 | |
| Difference‡ | 0.00 (0.07) | 35 | −0.02 (0.08) | 39 | |||
| DlCO† | Samplex mean (SD) | 6.90 (2.21) | 30 | 6.18 (3.32) | 28 | 0.850 | |
| Difference‡ | −0.35 (1.68) | 21 | −0.46 (2.04) | 15 | |||
| 6-min-walk distance† | Sample mean (SD) | 238.5 (88.62) | 32 | 222.25 (109.96) | 36 | 0.177 | |
| Difference‡ | 8.80 (72.17) | 31 | −12.85 (55.34) | 34 | |||
| Time to NIV† | Sample mean (SD) | 188.0 ± 8.9 | 3 | 234.7 ± 178.3 | 3 | NA |
Definition of abbreviations: CI = confidence interval; COPD = chronic obstructive pulmonary disease; HFNC = high-flow nasal cannula oxygen therapy; LSM = least squares mean; LTOT = long-term oxygen therapy; MRC = Medical Research Council; NA = not applicable; NIV = noninvasive ventilation; SpO2 = oxygen saturation as measured by pulse oximetry; VC = vital capacity.
*
LSM at 52 weeks.
†
Changes in the sample means at 52 weeks.
‡
Difference between the baseline and 52-week data.