Table 2.
Outcome measures in patients treated with placebo and montelukast
| Placebo (n = 20) | Montelukast (n = 20) | P | |
|---|---|---|---|
| sVCAM, ng/mL | |||
| Prerandomization | 945.0 (814.0-1254.5) | 956.0 (694.0-1080.0) | .44 |
| Week 8 | 900.5 (865.5-1403.5) | 908.5 (668.0-1158.5) | .37 |
| % Change | 4.17 (−3.3 to +12.1) | −3.2 (−13.6 to +11.6) | .16 |
| sP-sel, ng/mL | |||
| Prerandomization | 44.5 (35.0-63.5) | 49.5 (43.0-62.5) | .24 |
| Week 8 | 46.5 (31.0-52.5) | 49.5 (35.5-59.5) | .18 |
| % Change | −6.2 (−21.1 to +14.7) | −7.7 (−21.4 to +11.2) | .98 |
| sE-sel, ng/mL | |||
| Prerandomization | 45.0 (31.5-61.0) | 52.5 (33.0-65.5) | .47 |
| Week 8 | 44.0 (30.5-55.0) | 49.5 (34.0-55.0) | .53 |
| % Change | −7.4 (−14.8 to 0) | −2.5 (−18.5 to +8.9) | .88 |
| LTE4, pg/mg | |||
| Prerandomization | 2145.5 (1607.0-2643.0) | 2055.5 (1579.0-2493.5) | .66 |
| Week 8 | 1920.5 (1666.0-2339.0) | 1787.5 (1480.5-2196.5) | .39 |
| % Change | −3.1 (−21.3 to +33.0) | −10.0 (−29.7 to +28.6) | .74 |
| Daily mean pain score | |||
| Prerandomization | 5.0 (3.8-5.9) | 4.3 (4.0-5.0) | .20 |
| Postrandomization | 5.2 (3.9-5.8) | 4.6 (3.2-6.3) | .29 |
| % Change | −3.8 (−12.9 to +15.4) | 5.7 (−7.7 to +31.8) | .42 |
| Daily median pain score | |||
| Prerandomization | 5.0 (4.0-6.0) | 4.0 (4.0-5.0) | .29 |
| Postrandomization | 5.0 (4.0-6.0) | 4.0 (3.0-5.5) | .20 |
| % Change | 0 (−16.7 to +15.5) | 0 (0-33.3) | .53 |
| Pain days with pain score ≥5, % | |||
| Prerandomization | 15.5 (6.7-42.9) | 13.4 (0-23.8) | .31 |
| Postrandomization | 14.9 (3.5-31.5) | 4 (1.8-13.2) | .09 |
| % Change | −1.5 (−4.7 to +1.4) | −2.5 (−12.5 to +2.6) | .78 |
| Days with pain crisis episode, % | |||
| Prerandomization | 4.6 (0-16.7) | 0 (0-0) | .024 |
| Postrandomization | 3.5 (0-15.8) | 0 (0-2.5) | .030 |
| % Change | 0 (−4.6 to +3.5) | 0 (0-1.5) | .58 |
| FEV1 predicted, % | |||
| Prerandomization | 83.0 (74.0-91.0) | 92.0 (81.0-100.5) | .06 |
| Week 8 | 82.0 (70.0-94.0) | 86.5 (77.0-100.0) | .22 |
| % Change | −1.2 (−4.1 to +4.1) | −2.2 (−8.6 to +1.64) | .84 |
| FVC predicted, % | |||
| Prerandomization | 82.0 (80.0-95.0) | 96 (87.5-106.0) | .024 |
| Week 8 | 84 (75-99) | 92.5 (85.5-103.5) | .09 |
| % Change | 1.0 (−1.9 to +4.0) | −1.5 (−4.3 to +3.8) | .35 |
| FEV1/FVC predicted, % | |||
| Prerandomization | 83.0 (78.0-98.0) | 86.0 (80.0-93.5) | .73 |
| Week 8 | 84.0 (75.0-98.0) | 85.0 (78.0-96.5) | .0 |
| % Change | 0 (−3.9 to +1.4) | 1.8 (−1.7 to +2.9) | .27 |
| TLC predicted, % | |||
| Prerandomization | 88.0 (79.0-92.0) | 99.0 (88.0-114.0) | .044 |
| Week 8 | 88.0 (79.0-97.0) | 94.0 (87.0-109.0) | .17 |
| % Change | 2.9 (0-5.1) | 0 (−9.1 to +6.8) | .65 |
| TH1, s | |||
| Prerandomization | 3.2 (2.5-4.1) | 4.3 (2.6-7.4) | .9755 |
| Week 8 | 2.5 (2.3-2.9) | 3.1 (2.5-7.6) | .10 |
| % Change | −34.1 (−49.2 to −18.0) | 2.9 (−8.8 to +74.8) | .07 |
Twenty-one patients underwent LDV (10 placebo and 11 montelukast). TLC predicted values were available for 20 patients (9 placebo and 11 montelukast). Data are median (IQR).
FEV1, forced expiratory volume in 1 second; TH1, time to half-peak of hyperemia.