Clareo Health | Prevention of Asthma With Levocetirizine 18 Month Treatment in Infants (12 - 24 Months) Suffering From Eczema (Atopic Dermatitis) and Sensitized to Grass Pollen and/or House Dust Mite (HDM)
Prevention of Asthma With Levocetirizine 18 Month Treatment in Infants (12 - 24 Months) Suffering From Eczema (Atopic Dermatitis) and Sensitized to Grass Pollen and/or House Dust Mite (HDM)
Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
UCB Pharma SA
Age
1–2
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
Children of either sex aged between 12 and 24 months
Subjects suffering from symptoms of Atopic Dermatitis (AD) lasting cumulatively for at least 2 months since birth
Modified Severity Scoring of Atopic Dermatitis (SCORAD) Index \>= 10
Subjects whose biological mother or father, or one sibling has a well-documented history of atopy (AD, allergic rhinitis or asthma)
Results of the Radio-allergosorbant (RAST) test for grass pollen (GP) and house dust mite (HDM) are available and Immunoglobulin E (IgE) level against GP \>= 0.35 kUA/l and/or IgE level against HDM ≥ 0.35 kUA/l
Safety laboratory results are within the normal range of the central laboratory or considered as not clinically significant or study disease related by the Investigator
You may not be if
Are to be excluded from the participation in the study, those children who
Have height or weight below the 5th percentile
Have experienced at least one episode of wheezing when aged 6 months or over
Have suffered at age 6 months or over, from at least one nocturnal cough episode consisting of 3 (or more) consecutive nights resulting in sleep disturbances in a clinical setting where asthma is likely and other conditions have been excluded
Have chronic pulmonary diseases of any type, such as, but not limited to, cystic fibrosis, or any cranio-facial abnormality, e.g., cleft palate
Have a personal history of sleep apnea or who have siblings with a history of sleep apnea
Are treated with any immunomodulator medication such as, e.g., cyclosporin, cyclophosphamide or FK 506 (Tacrolimus)
Have received or are receiving allergen - specific immunotherapy
Suffer from concomitant dermatological disease/condition other than atopic dermatitis, that might interfere with the evaluation of the clinical response for atopic dermatitis
Have an insufficient wash-out period for the following medications:
* Intranasal or systemic antihistamines: 3 days,
* Intranasal or systemic decongestants: 3 days,
* Loratadine, Desloratadine: 10 days,
* Chromones: 2 weeks,
* Oral corticosteroids: 1 month,
* Chronic use (i.e. cumulatively up to 2 weeks within the last 3 months) of inhaled/intranasal corticosteroids: 1 month,
* Ketotifen: 1 month,
* Astemizole: 6 weeks
Have been treated with any antihistamine, including ketotifen, with daily intake for more than 2 consecutive months in the last 6 months before screening
Intake of any prohibited medication listed above during the selection period
