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)

Verified by: UCB, Inc., May 2011
First Received: September 8, 2005 | Last Updated: August 30, 2011 | Phase: Phase 3 | Start Date: June 2004
Overall Status: Terminated | Estimated Enrollment: 207
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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...

Brief Summary

Official Title: “The Prolongation of the EPAAC™ Trial - NCT00152464 (The Early Prevention of Asthma in Atopic Children). A Multi-country, Double Blind, Placebo (PLC) Controlled, Follow-up Trial With 3 Parallel Groups (LCTZ-LCTZ, LCTZ-PLC and PLC-PLC) : Evaluation of the Long Term Efficacy and Safety of Levocetirizine (LCTZ) (5 mg/ml Oral Drops -0.125 mg/kg b.w. b.i.d.) Administered for an Additional 18 Months Period in Preventing the Onset of Asthma in Children Coming From the EPAAC Trial.”

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.

  • Study Type: Interventional
  • Study Design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
  • Study Primary Completion Date: March 2006

Intervention(s) in this Clinical Trial

  • Drug: LEVOCETIRIZINE
    • 5mg/mL oral drops, 0.125 mg/kg body weight, bid for 18 months
  • Other: Placebo
    • Oral drops, bid for 18 months

Arms, Groups and Cohorts in this Clinical Trial

  • Experimental: LCTZ-LCTZ
    • Levocetirizine after having been randomized to Levocetirizine in the preceding A00309 trial - NCT00152464 (LCTZ-LCTZ)
  • Placebo Comparator: LCTZ-PLC
    • Placebo after having been randomized to Levocetirizine in the preceding A00309 trial - NCT00152464 (LCTZ - PLC)
  • Placebo Comparator: PLC-PLC
    • Placebo after having been randomized to Placebo in the preceding A00309 trial - NCT00152464 (PLC-PLC)

Outcome Measures for this Clinical Trial

Primary Measures

  • Time to Onset of Asthma
    • Time Frame: 36 months (from the randomization visit to the preceding A00309 - NCT00152464 trial onwards.)
      Safety Issue?: No

Secondary Measures

  • Time to Onset of Asthma in the Subset of Subjects Still Asthma Free After First 18 Months.
    • Time Frame: 18 months (from the end of the preceding A00309 - NCT00152464 trial onwards.)
      Safety Issue?: No

Criteria for Participation in this Clinical Trial

Inclusion Criteria:

  • Inclusion criteria which must be verified at the end of first 18-months treatment (Visit 9)
  • Having completed the previous 18-month treatment period of the EPAAC trial -
  • NCT00152464

Exclusion Criteria:

  • None

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 30 Months

Maximum Age for this Clinical Trial: 42 Months

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Clinical Trial Investigator Information

Lead Investigator: UCB, Inc. Industry

Overall Clinical Trial Officials and Contacts

Isabelle Campine, MD Study Director UCB, Inc.  

Additional Information

Information obtained from ClinicalTrials.gov on February 12, 2012

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00160563

Study ID Number: A00384

ClinicalTrials.gov Identifier: NCT00160563

Health Authority: France: Afssaps - French Health Products Safety Agency

For FDA Safety Alerts and Recalls refer to

Product Information

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