At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 514 enrolled
Drug / intervention
Placebo +1 moredrug
Likely dose
Levocetirizine 0.125 mg/kg body weight twice daily as oral drops (5 mg/ml concentration)AI-extracted
Key inclusion· 5
- ✓Age 12 to 24 months
- ✓Atopic dermatitis with SCORAD index ≥10, lasting cumulatively ≥2 months since birth
- ✓Modified Severity Scoring of Atopic Dermatitis (SCORAD) Index >= 10
- ✓Family history of atopy (parent or sibling with documented AD, allergic rhinitis, or asthma)
Key exclusion· 9
- ✕Height or weight below 5th percentile
- ✕Any wheezing episode at age ≥6 months
- ✕Nocturnal cough (≥3 consecutive nights with sleep disturbance) at age ≥6 months in clinical setting where asthma is likely
- ✕Chronic pulmonary disease (e.g., cystic fibrosis) or cranio-facial abnormality (e.g., cleft palate)
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
The Early Prevention of Asthma in Atopic Children (EPAAC™) Study. A Multi-country, Double Blind, Placebo (PLC) Controlled, Randomized, Parallel Group Trial: Evaluation of the Efficacy and Safety of Levocetirizine (LCTZ) (5 mg/ml Oral Drops -0.125 mg/kg b.w. b.i.d.) Administered for 18 Months in Preventing the Onset of Asthma in 12 to 24 Months Old Children Who Suffer From Atopic Dermatitis and Are Sensitized to Grass Pollen and / or House Dust Mite Allergens.
In Brief
A Phase 3 clinical trial evaluating Placebo and Levocetirizine for Dermatitis, Atopic. Completed, enrolled 514 participants.
Detailed Summary
The Early Prevention of Asthma in Atopic Children (EPAAC™). 24 months study to evaluate the efficacy and safety of levocetirizine (LCTZ) in preventing the onset of asthma in 12 to 24 months old children.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsDermatitis, Atopic
Countries--
Collaborators--
Timeline
Phase 3CompletedFinished
20022003200420052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
Enrollment StartMar 2002
First PostedSep 2005
Primary CompletionMar 2006
TodayJul 2026
First PostedSep 9, 2005
Enrollment StartMar 20, 2002
Primary CompletionMar 15, 2006
TodayJul 2, 2026
Enrollment to primary: 4.0 yearsPosted 20.8 years ago
Interventions
Placebodrug
Pharmaceutical form: Oral drops Route of administration: Oral use
Levocetirizinedrug
Pharmaceutical form: Oral drops Concentration: 5 mg/ml Route of administration: Oral use