ALLERGIC FACTORS ASSOCIATED WITH THE DEVELOPMENT OF ASTHMA AND THE INFLUENCE OF CETIRIZINE IN A DOUBLE-BLIND, RANDOMIZED, PLACEBO-CONTROLLED TRIAL - FIRST RESULTS OF ETAC(R)
Jo. Warner et al., ALLERGIC FACTORS ASSOCIATED WITH THE DEVELOPMENT OF ASTHMA AND THE INFLUENCE OF CETIRIZINE IN A DOUBLE-BLIND, RANDOMIZED, PLACEBO-CONTROLLED TRIAL - FIRST RESULTS OF ETAC(R), Pediatric allergy and immunology, 9(3), 1998, pp. 116-124
There is a common progression known as the allergic march from atopic
dermatitis to allergic asthma. Cetirizine has several antiallergic pro
perties that suggest a potential effect on the development of airway i
nflammation and asthma in infants with atopic dermatitis. Methods. Ove
r a two year period, 817 infants aged one to two years who suffered fr
om atopic dermatitis and with a history of atopic disease in a parent
or sibling were included in the ETAC(R) (Early Treatment of the Atopic
Child) trial, a multi-country, double-blind, randomised, placebo-cont
rolled trial. The infants were treated for 18 months with either cetir
izine (0.25mg/ kg b.i.d.) or placebo. The number of infants who develo
ped asthma was compared between the two groups. Clinical and biologica
l assessments including analysis of total and specific IgE antibodies
were performed. Results. In the placebo group, the relative risk (RR)
for developing asthma was elevated in patients with a raised level of
total IgE (greater than or equal to 30 kU/l) or specific IgE (greater
than or equal to 0.35 kUA/l) for grass pollen, house dust mite or cat
dander (RR between 1.4 and 1.7). Compared to placebo, cetirizine signi
ficantly reduced the incidence of asthma for patients sensitised to gr
ass pollen (RR = 0.5) or to house dust mite (RR = 0.6). However, in th
e population that included all infants with normal and elevated total
or specific IgE (intention-to-treat - ITT), there was no difference be
tween the numbers of infants developing asthma while receiving cetiriz
ine or placebo. The adverse events profile was similar in the two trea
tment groups. Discussion. Raised total IgE level and raised specific I
gE levels to grass pollen, house dust mite or cat dander were predicti
ve of subsequent asthma. Cetirizine halved the number of patients deve
loping asthma in the subgroups sensitised to grass pollen or house dus
t mite (i.e. 20% of the study population). In view of the proven safet
y of the drug, we propose this treatment as a primary pharmacological
intervention strategy to prevent the development of asthma in specific
ally sensitised infants with atopic dermatitis.