|
|
Adult and adolescent patients 15 years of age and older |
one 10 mg tablet |
|
|
Adult and adolescent patients 15 years of age and older |
one 10 mg tablet |
|
|
Adult and adolescent patients 15 years of age and older |
one 10 mg tablet |
|
|
Adult and adolescent patients 15 years of age and older |
one 10 mg tablet |
|
||
Montelukast Sodium 10 mg/day (%) (n=1,955) |
Placebo (%) (n=1,180) |
|
|
||
Pain, abdominal |
2.9 |
2.5 |
Asthenia/fatigue |
1.8 |
1.2 |
Fever |
1.5 |
0.9 |
Trauma |
1.0 |
0.8 |
|
||
Dyspepsia |
2.1 |
1.1 |
Pain, dental |
1.7 |
1.0 |
Gastroenteritis, infectious |
1.5 |
0.5 |
|
||
Headache |
18.4 |
18.1 |
Dizziness |
1.9 |
1.4 |
|
||
Influenza |
4.2 |
3.9 |
Cough |
2.7 |
2.4 |
Congestion, nasal |
1.6 |
1.3 |
|
||
Rash |
1.6 |
1.2 |
|
||
ALT increased |
2.1 |
2.0 |
AST increased |
1.6 |
1.2 |
Pyuria |
1.0 |
0.9 |
|
||||||
Endpoint |
Montelukast Sodium Tablets |
Placebo |
||||
N |
Baseline |
Mean Change from Baseline |
N |
Baseline |
Mean Change from Baseline |
|
Daytime Asthma Symptoms (0 to 6 scale) |
372 |
2.35 |
-0.49*
|
245 |
2.40 |
-0.26 |
β-agonist (puffs per day) |
371 |
5.35 |
-1.65*
|
241 |
5.78 |
-0.42 |
AM PEFR (L/min) |
372 |
339.57 |
25.03*
|
244 |
335.24 |
1.83 |
PM PEFR (L/min) |
372 |
355.23 |
20.13*
|
244 |
354.02 |
-0.49 |
Nocturnal Awakenings (#/week) |
285 |
5.46 |
-2.03*
|
195 |
5.57 |
-0.78 |
|
|||
Time of exercise challenge following medication administration |
Mean Maximum percent fall in FEV1* |
Treatment difference % for Montelukast Sodium versus Placebo (95% CI)* |
|
|
Montelukast Sodium |
Placebo |
|
2 hours |
13 |
22 |
-9 (-12, -5) |
8.5 hours |
12 |
17 |
-5 (-9, -2) |
24 hours |
10 |
14 |
-4 (-7, -1) |
|
|||
|
|||
|
|||
Treatment Group (N) |
Baseline Mean Score |
Mean Change from Baseline |
Difference Between Treatment and Placebo (95% CI) Least-Squares Mean |
Montelukast sodium 10 mg (344) |
2.09 |
-0.39 |
-0.13† (-0.21, -0.06) |
Placebo (351) |
2.10 |
-0.26 |
N.A. |
Active Control‡
(Loratadine 10 mg) (599) |
2.06 |
-0.46 |
-0.24† (-0.31, -0.17) |
|
|||
|
|||
Treatment Group (N) |
Baseline Mean Score |
Mean Change from Baseline |
Difference Between Treatment and Placebo (95% CI) Least- Squares Mean |
Montelukast 10 mg (1,000) |
2.09 |
-0.42 |
-0.08† (-0.12, -0.04) |
Placebo (980) |
2.10 |
-0.35 |
N.A. |