Table 1:
Pooled patient demographic and baseline characteristics
| Characteristics | Placebo overall (n=371) |
LUM/IVA overall | |||
|---|---|---|---|---|---|
| ppFEV1 <40* (n=53) |
ppFEV1 ≥40 (n=678) |
ppFEV1 <70 (n=527) |
ppFEV1 ≥70 (n=204) |
||
| Female, n (%) | 181 (48∙8) | 31 (58∙5) | 331 (48∙8) | 269 (51∙0) | 93 (45∙6) |
| Age, mean (range), years | 25∙4 (12–64) | 27∙3 (13–44) | 24∙7 (12–57) | 26∙3 (12–57) | 21∙0 (12–53) |
| ppFEV1 at baseline, mean (range) | 60·4 (33·9–99·8) | 37·2 (31·1–39·9) | 62·5 (40·0–96·5) | 54·0 (31·1–69·8) | 77·9 (70·0–96·5) |
| Body mass index (mg/kg2), mean (range) | 21·0 (14·1–32·2) | 20·9 (16·1–31·4) | 21·3 (14·2–35·1) | 21·2 (14·2–35·1) | 21·4 (14·6–29·8) |
| Chronic CF therapy use at baseline, n (%) | |||||
| Bronchodilators (any) | 342 (92·2) | 50 (94·3) | 631 (93·1) | 496 (94·1) | 185 (90·7) |
| Dornase alfa | 281 (75·7) | 41 (77·4) | 517 (76·3) | 407 (77·2) | 151 (74·0) |
| Inhaled antibiotic | 258 (69·5) | 33 (62·3) | 421 (62·1) | 351 (66·6) | 103 (50·5) |
| Inhaled hypertonic saline | 220 (59·3) | 34 (64·2) | 386 (56·9) | 294 (55·8) | 126 (61·8) |
| Inhaled corticosteroids | 220 (59·3) | 35 (66·0) | 386 (56·9) | 311 (59·0) | 110 (53·9) |
*
Eighty-one patients (placebo, n=28; LUM/IVA, n=53) had ppFEV1 that decreased to <40 between screening and baseline.
CF=cystic fibrosis; IVA=ivacaftor; LUM=lumacaftor; ppFEV1=percent predicted forced expiratory volume in 1 second.