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.

Condition	Intervention	Phase
Prevention of asthma	Drug: LEVOCETIRIZINE	Phase III

Further Study Details: 

Primary Outcomes: 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 Outcomes: 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
Expected Total Enrollment:  300

Ages Eligible for Study:  30 Months   -   42 Months,  Genders Eligible for Study:  Both

Criteria

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

Please refer to this study by ClinicalTrials.gov identifier  NCT00160563

UCB - Clinical Trial Call Center      +1 877 822 9493 

Australia
      Westmead (Sydney),  Australia; Recruiting
      Subiaco (Perth),  Australia; Recruiting
      Parkville (North Melbourne),  Australia; Recruiting
      North Adelaide,  Australia; Recruiting
Austria
      Graz,  Austria; Recruiting
Belgium
      BRUXELLES,  Belgium; Recruiting
      Aalst,  Belgium; Recruiting
Czech Republic
      HRADEC KRALOVE,  Czech Republic; Recruiting
      Plezen-Lochotin,  Czech Republic; Recruiting
      Olomouc,  Czech Republic; Recruiting
      Praha 5,  Czech Republic; Recruiting

Study chairs or principal investigators

Isabelle Campine, MD,  Study Director,  UCB Pharma, Inc.   

Study ID Numbers:  A00384; EudraCT number 2004-000187-28
Last Updated:  September 11, 2005
Record first received:  September 8, 2005
ClinicalTrials.gov Identifier:  NCT00160563
Health Authority: France: Afssaps - French Health Products Safety Agency; Italy: Ministry of Health; Germany: Federal Institute for Drugs and Medicinal Devices; Czech Republic: State Institute for Drug Control; Poland: Ministry of Health; Spain: Ministry of Health and Consumption; South Africa: Medicines Control Council; Australia: Department of Health and Ageing Therapeutic Goods Administration; Belgium: Directorate general for the protection of Public health: Medicines; United Kingdom: Medicines and Healthcare Products Regulatory Agency
ClinicalTrials.gov processed this record on 2005-09-13