Official Title: “The Prolongation of the EPAAC™ Trial (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 (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: Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Safety/Efficacy Study

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

Primary Measures

• Time to onset of asthma
  • Time Frame: 36 months (from the randomization visit to the preceding A00309 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 trial onwards.)
    Safety Issue?: No

Inclusion Criteria:

• Inclusion criteria which must be verified at the end of first 18-months treatment (V9)
:
• Having completed the previous 18-month treatment period of the EPAAC trial

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

Lead Sponsor: UCB

Overall Clinical Trial Officials and Contacts

Isabelle Campine, MD Study Director UCB  

Information obtained from ClinicalTrials.gov on July 02, 2009

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