US2002156086A1PendingUtilityA1
Method for preventing the onset of asthma
Priority: Aug 18, 1998Filed: Apr 3, 2002Published: Oct 24, 2002
Est. expiryAug 18, 2018(expired)· nominal 20-yr term from priority
A61K 31/4439A61K 31/495
43
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Claims
Abstract
The present invention relates to a method for preventing the onset of asthma which comprises administering to a patient a therapeutically effective amount of cetirizine, an individual optical isomer thereof or a pharmaceutically acceptable salt thereof.
Claims
exact text as granted — not AI-modified1 . Use of cetirizine, an individual optical isomer thereof or a pharmaceutically acceptable salt thereof for the preparation of a medicament intended for preventing the onset of asthma in a patient.
2 . Use of cetirizine, an individual optical isomer thereof or a pharmaceutically acceptable salt thereof for the preparation of a medicament intended for preventing the onset of asthma in a patient, the said medicament being administered to the patient prophylactically prior to the onset of asthma.
3 . Use of cetirizine, an individual optical isomer thereof or a pharmaceutically acceptable salt thereof for the preparation of a medicament intended for preventing the sensitisation of patient at risk of developing asthma diseases.
4 . Use according to claim 1 , 2 or 3 , wherein the salt is the cetirizine dihydrochloride.
5 . Use according to claim 1 , 2 , 3 or 4 , wherein the patient is an infant or a child.
6 . Use according to claim 5 , wherein the patient is aged 1 to 4 years.
7 . Use according to any one of claims 1 to 6 , which comprises administering a daily dosage from about 0.0005 mg to about 2 mg of said cetirizine, said individual optical isomer thereof or said pharmaceutically acceptable salt thereof, per kg of body weight per patient.
8 . Use according to claim 7 , which comprises administering a daily dosage from about 0.05 mg to about 1 mg per kg of body weight per patient.
9 . Use according to any one of claims 1 to 8 , which comprises administration 1 to 3 times a day.
10 . Use according to any one of claims 1 to 10 , wherein said cetirizine, said individual optical isomer thereof or said pharmaceutically acceptable salt thereof is administered orally.
11 . A method for preventing the onset of asthma which comprises administering to a patient a therapeutically effective amount of cetirizine, an individual optical isomer thereof or a pharmaceutically acceptable salt thereof.
TABLE 1
Occurrence of Asthma by Baseline Atopic Characteristics Placebo ITT
Population (n = 397)
RR for
developing
asthma in
presence of
elevated
Log-Rank
Normal
Elevated
marker
Test
(%)
(%)
[95% CI]
p value
Total IgE (PRIST)*
(33.5)
(43.6)
1.3
0.027
[1.0 ; 1.7]
IgE Grass pollen (GX1)*
(35.0)
(58.8)
1.7
<0.001
[1.2 ; 2.3]
IgE HDM (D1)*
(34.7)
(51.5)
1.5
0.005
[1.1 ; 2.0]
IgE Cat dander (E1)*
(33.2)
(47.1)
1.4
0.032
[1.0; 1.9]
IgE Egg (F1)*
(30.7)
(39.3)
1.3
0.152
[0.9; 1.8]
IgE Milk (F2)*
(36.0)
(40.9)
1.1
0.250
[0.9; 1.5]
IgE HDM + Grass Pollen
(32.9)
(53.7)
1.6
<0.001
[1.2 ; 2.1]
Eosinophil count
(34.9)
(47.6)
1.4
0.066
[1.0; 1.9]
TABLE 2
Occurrence of Asthma by Treatment in the ITT population
RR for
developing
asthma when
when
cetirizine
Log-Rank
Placebo
Certirizine
treated
Test
(%)
(%)
[95% CI]
p value
ITT population
(38.0)
(37.7)
[0.8; 1.2]
0.973
Subgroups with elevated IgE or eosinophils at baseline
Total IgE (PRIST)*
(43.6)
(38.1)
0.9
0.391
[0.7 ; 1.1]
IgE Grass pollen (GX1)*
(58.8)
(27.8)
0.5
0.002
[0.3 ; 0.9]
IgE HDM (D1)*
(51.5)
(28.6)
0.6
0.005
[0.3 ; 0.9]
IgE Cat dander (E1)*
(47.1)
(40.6)
0.9
0.610
[0.6 ; 1.3]
IgE Egg (F1)*
(39.3)
(31.2)
0.8
0.292
[0.6 ; 1.1]
IgE Milk (F2)*
(40.9)
(30.7)
0.7
0.140
[0.5 ; 1.0]
IgE HDM + Grass Pollen
(53.7)
(34.2)
0.6
0.006
[0.4 ; 0.9]
Eosinophil count
(47.6)
(42.7)
0.9
0.674
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