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Prevention of Asthma With Levocetirizine (36 Month Treatment) in Young Children Suffering From Eczema (Atopic Dermatitis) and Sensitized to Grass Pollen and House Dust Mite and Having Completed the Previous EPAAC Trial (NCT00152464)

NCT00160563 · Status: TERMINATED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 207

Last updated 2015-03-03

Study results available
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Summary

Prolongation of the EPAAC™ trial - NCT00152464 (The Early Prevention of Asthma in Atopic Children).

36 months study to evaluate the efficacy and safety of levocetirizine (LCTZ) in preventing the onset of asthma in young atopic children.

Conditions

Interventions

DRUG

LEVOCETIRIZINE

5mg/mL oral drops, 0.125 mg/kg body weight, bid for 18 months

OTHER

Placebo

Oral drops, bid for 18 months

Sponsors & Collaborators

  • UCB Pharma

    lead INDUSTRY

Principal Investigators

  • Isabelle Campine, MD · UCB Pharma

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
30 Months
Max Age
42 Months
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2004-06-30
Primary Completion
2006-03-31
Completion
2006-03-31

Countries

  • Australia
  • Belgium
  • Czechia
  • France
  • Germany
  • Italy
  • Poland
  • South Africa
  • Spain
  • United Kingdom

Study Locations

More Related Trials

Entities

Diseases

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 NCT00160563 on ClinicalTrials.gov