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 |
| FEV1predicted, % | |||
| 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 |
| . | 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 |
| FEV1predicted, % | |||
| 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.