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...
Date First Received: September 8, 2005
Last Updated: March 6, 2008
Verified by: UCB, March 2008
Clinical Trial Phase: Phase 3 | Start Date: June 2004
Overall Status: Completed
Estimated Enrollment: 300
Brief Summary
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.”
Condition Keyword(s):
Intervention(s):
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: Randomized, Double-Blind, Placebo Control, Parallel Assignment
Study Primary Completion Date: March 2006
Intervention(s) in this Clinical Trial
- Drug: LEVOCETIRIZINE
Outcome Measures for this Clinical Trial
Primary Measures
- To assess the effect on the time to onset of asthma of 36-month treatment with Levocetirizine as compare to placebo, in asthma free young atopic children sensitized to Grass Pollen (GP) and/or House Dust Mite allergens (HDM).
Secondary Measures
- To investigate the clinical benefit on the time to onset of asthma after 36-month of treatment in the LCTZ-LCTZ group as compared to LCTZ-PLC group.
- To investigate whether the benefit on the time to onset of asthma after 18-month of treatment with LCTZ can be maintained over an additional 18-month period, once active treatment is stopped
- To investigate the clinical benefit on the time to onset of asthma of an additional 18-month treatment period in the subset of subjects still asthma-free after the first 18-month treatment period.
- To assess the safety of the long-term use of LCTZ in a large population of children aged between 30 and 60 months
Criteria for Participation in this Clinical Trial
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
- None
Exclusion Criteria:
Gender Eligibility for this Clinical Trial: Both
Minimum Age for this Clinical Trial: 30 Months
Maximum Age for this Clinical Trial: 42 Months
Clinical Trial Sponsor Information
Lead Sponsor: UCB
Overall Clinical Trial Officials and Contacts
Isabelle Campine, MD Study Director UCB
Additional Information
Information obtained from ClinicalTrials.gov on November 19, 2008
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
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