|
FSC 100/50 |
FP 100 |
Screening |
FEV1 pre-exercise, L |
2.19 ± 0.696 |
2.19 ± 0.711 |
Maximum fall in FEV1 post-exercise, % |
-24.3 ± 10.87 |
-24.9 ± 10.27 |
Post-Run-In (Pre-Randomization) |
FEV1 pre-exercise, |
2.21 ± 0.720 |
2.21 ± 0.711 |
Maximum fall in FEV1 post-exercise, % |
-27.1 ± 7.77 |
-28.0 ± 8.59 |
Morning PEF, L/minute |
268.5 ± 9.14 |
274.2 ± 10.36 |
Evening PEF, L/minute |
286.6 ± 9.24 |
293.8 ± 10.78 |
Albuterol-free days, % |
36.5 ± 3.33 |
41.5 ± 3.54 |
Symptom-free days, % |
15.8 ± 2.24 |
18.0 ± 2.30 |
Post Treatment (4 weeks) |
FEV1 pre-exercise, L |
2.27 ± 0.073 |
2.24 ± 0.077 |
Maximum fall in FEV1 post-exercise, % |
-9.9 ± 1.01 |
-11.1 ± 1.02 (p=0.158) |
Morning PEF, L/minute |
292.7 ± 9.57 |
290.4 ± 11.10 |
Change from baseline of morning PEF, L/minute |
23.7 ± 3.95 |
14.2 ± 4.45 (p=0.093) |
Evening PEF, L/minute |
302.3 ± 9.70 |
297.3 ± 10.91 |
Change from baseline of evening PEF, L/minute |
14.3 ± 3.44 |
6.2 ± 3.70 (p=0.107) |
Albuterol-free days, % |
53.4 ± 4.23 |
60.0 ± 3.91 |
Change from baseline of % albuterol-free days |
16.9 ± 3.23 |
19.1 ± 3.92 (p=0.256) |
Symptom-free days, % |
27.2 ± 3.89 |
36.2 ± 4.00 |
Change from baseline of % symptom-free days |
10.9 ± 3.19 |
18.6 ± 4.11 (p=0.056) |