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
Information source: UCB
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Prevention of Asthma
Intervention: LEVOCETIRIZINE (Drug)
Phase: Phase 3
Status: Completed
Sponsored by: UCB Official(s) and/or principal investigator(s):
Isabelle Campine, MD, Study Director, Affiliation: UCB
Summary
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.
Clinical Details
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.
Study design: Randomized, Double-Blind, Placebo Control, Parallel Assignment
Primary outcome: 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 outcome: 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
Eligibility
Minimum age: 30 Months.
Maximum age: 42 Months.
Gender(s): 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
Locations and Contacts
Parkville (North Melbourne), Australia
North Adelaide, Australia
Bruxelles, Belgium
Hradec Kralove, Czech Republic
Plezen-Lochotin, Czech Republic
Olomouc, Czech Republic
Praha 5, Czech Republic
Praha 8, Czech Republic
Ostrava 9, Czech Republic
Brno, Czech Republic
Saint-Etienne Cedex 2, France
Tarbes Cedex, France
Toulouse Cedex 3, France
Martigues, France
Bayreuth, Germany
Berlin, Germany
Bochum, Germany
Koln, Germany
Munchen, Germany
Wesel, Germany
Erlangen, Germany
Bielefeld, Germany
Ancona, Italy
Bari, Italy
Napoli, Italy
Milano, Italy
Roma, Italy
Pavia, Italy
Bologna, Italy
Messina, Italy
Wroclaw, Poland
Lodz, Poland
Lublin, Poland
Bialystock, Poland
Rabka Zdroj, Poland
Karpacz, Poland
Gdansk, Poland
Warszawa, Poland
Durban, South Africa
Clarement, South Africa
Sydenham, South Africa
Mowbray, South Africa
Wynberg, South Africa
Bellville, South Africa
Pietermaritzburg, South Africa
Westville, South Africa
West Honeydew, South Africa
Barcelona, Spain
Espluques de Llobreqat, Spain
Dorchester, United Kingdom
Southampton, United Kingdom
Enfield, United Kingdom
Additional Information
Starting date: June 2004
Ending date: March 2006
Last updated: March 6, 2008
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