Clinical trial NCT00160563: 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)
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.
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE3
Conditions: Asthma
Keywords: Pediatry
EPAAC
atopic Children
prevention of asthma
Levocetirizine
Xyzal
Lead sponsor: UCB Pharma
Sponsor class: INDUSTRY
First posted: 2005-09-12
Enrollment: 207
Sex: ALL
Minimum age (years): 30
Maximum age (years): 42
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility criteria: 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

Primary outcomes:
measure: Time to Onset of Asthma
timeFrame: 36 months (from the randomization visit to the preceding A00309 - NCT00152464 trial onwards.)
Secondary outcomes:
measure: Time to Onset of Asthma in the Subset of Subjects Still Asthma Free After First 18 Months.
timeFrame: 18 months (from the end of the preceding A00309 - NCT00152464 trial onwards.)
Other outcomes:
Locations:
city: North Adelaide
country: Australia
city: Parkville (North Melbourne)
country: Australia
city: Bruxelles
country: Belgium
city: Brno
country: Czech Republic
city: Hradec Kralove
country: Czech Republic
city: Olomouc
country: Czech Republic
city: Ostrava 9
country: Czech Republic
city: Plezen-Lochotin
country: Czech Republic
city: Praha 5
country: Czech Republic
city: Praha 8
country: Czech Republic
city: Martigues
country: France
city: Saint-Etienne Cedex 2
country: France
city: Tarbes Cedex
country: France
city: Toulouse Cedex 3
country: France
city: Bayreuth
country: Germany
city: Berlin
country: Germany
city: Bielefeld
country: Germany
city: Bochum
country: Germany
city: Erlangen
country: Germany
city: Koln
country: Germany
city: Munchen
country: Germany
city: Wesel
country: Germany
city: Ancona
country: Italy
city: Bari
country: Italy
city: Bologna
country: Italy
city: Messina
country: Italy
city: Milano
country: Italy
city: Napoli
country: Italy
city: Pavia
country: Italy
city: Roma
country: Italy
city: Bialystock
country: Poland
city: Gdansk
country: Poland
city: Karpacz
country: Poland
city: Lodz
country: Poland
city: Lublin
country: Poland
city: Rabka Zdroj
country: Poland
city: Warszawa
country: Poland
city: Wroclaw
country: Poland
city: Bellville
country: South Africa
city: Clarement
country: South Africa
city: Durban
country: South Africa
city: Mowbray
country: South Africa
city: Pietermaritzburg
country: South Africa
city: Sydenham
country: South Africa
city: West Honeydew
country: South Africa
city: Westville
country: South Africa
city: Wynberg
country: South Africa
city: Barcelona
country: Spain
city: Espluques de Llobreqat
country: Spain
city: Dorchester
country: United Kingdom
city: Enfield
country: United Kingdom
city: Southampton
country: United Kingdom
Study officials:
affiliation: UCB Pharma
name: Isabelle Campine, MD
role: STUDY_DIRECTOR
References: