MedTrace Logo

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)

NCT00152464 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 514

Last updated 2019-01-22

Study results available
· View outcomes & findings →

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.

Conditions

  • Dermatitis, Atopic

Interventions

DRUG

Placebo

Pharmaceutical form: Oral drops Route of administration: Oral use

DRUG

Levocetirizine

Pharmaceutical form: Oral drops Concentration: 5 mg/ml Route of administration: Oral use

Sponsors & Collaborators

  • UCB Pharma SA

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
12 Months
Max Age
24 Months
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2002-03-20
Primary Completion
2006-03-15
Completion
2006-03-15

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00152464 on ClinicalTrials.gov