TABLE 3.
Evaluation of the time to rescue WLL, numbers of patients requiring rescue WLL and temporal changes in key secondary outcome measures
| Outcome measure | Study month # | Control | rGM-CSF | p-value |
| Time to first rescue WLL (months), median (IQR) | NR | 18 (6–27) | 30 (30–30) | 0.0078 ¶ |
| Patients requiring rescue WLL (n (%)) | NR | 7 (78) | 1 (11) | 0.015 + |
| PaO2 (mmHg) | 3 | 68±10 | 89±9.2 | 0.0004 § |
| 10 | 73±13 | 92±12 | 0.0149 § | |
| 30 | 71±14 | 82±14 | 0.1158§ | |
| PA–aO2 (mmHg) | 3 | 37±12 | 18±8.1 | 0.0015 § |
| 10 | 34±13 | 18±12 | 0.0152 § | |
| 30 | 35±13 | 24±13 | 0.0921§ | |
| DLCO (% predicted) | 3 | 62±16 | 72±17 | 0.2287§ |
| 10 | 59±20 | 70±15 | 0.1833§ | |
| 30 | 59±21 | 63±15 | 0.6374§ | |
| VC (% predicted) | 3 | 78±17 | 80±15 | 0.7752§ |
| 10 | 78±14 | 82±18 | 0.6393§ | |
| 30 | 77±13 | 79±17 | 0.8159§ | |
| GGO score, median (IQR) | 0 | 5 (5–5) | 5 (5–5) | 0.9999¶ |
| 3 | 4 (4–5) | 3 (2–4) | 0.0332 ¶ | |
| 10 | 5 (3–5) | 3 (2–4) | 0.0676¶ | |
| 18 | 5 (4–5) | 3 (2–4) | 0.0629¶ | |
| 30 | 5 (4–5) | 4 (3–5) | 0.9999¶ | |
| SF-36 general health score | 3 | 79±18 | 93±6.1 | 0.0478 § |
| 10 | 72±26 | 84±15 | 0.2634§ | |
| 30 | 71±28 | 88±8.7 | 0.1043§ |
Data are presented as mean±sd, unless otherwise indicated. Bold text indicates statistical significance. WLL: (bilateral) whole lung lavage; rGM-CSF: recombinant granulocyte–macrophage colony-stimulating factor; IQR: interquartile range; NR: not relevant; PaO2: arterial oxygen tension; PA–aO2: alveolar–arterial oxygen tension difference; DLCO: diffusing capacity of the lungs for carbon monoxide; VC: (slow) vital capacity; GGO: ground glass opacification; SF-36: Short Form 36-question Health Survey. #: month 3=end of rGM-CSF induction therapy period, month 10=end of rGM-CSF maintenance therapy period, month 30=end of follow-up period (20 months after completing inhaled rGM-CSF therapy); ¶: Mann–Whitney U test; +: Fisher's exact test; §: t-test.