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)
NCT ID: NCT00160563
Last Updated: 2015-03-03
Study Results
Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.
View full resultsBasic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
TERMINATED
PHASE3
207 participants
INTERVENTIONAL
2004-06-30
2006-03-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
36 months study to evaluate the efficacy and safety of levocetirizine (LCTZ) in preventing the onset of asthma in young atopic children.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Prevention of Asthma With Levocetirizine 18 Month Treatment in Infants (12 - 24 Months) Suffering From Eczema (Atopic Dermatitis) and Sensitized to Grass Pollen and/or House Dust Mite (HDM)
NCT00152464
Safety Study of Levocetirizine Dihydrochloride Oral Liquid Formulation in Children Aged 6 Months to 11 Months
NCT00628108
Efficacy and Safety of Levocetirizine for Treatment of Recurrent Cough Associated With Other Allergic Symptoms in Children
NCT00520754
Efficacy and Safety of Levocetirizine and Fexofenadine in Reducing Symptoms of Seasonal Allergic Rhinitis
NCT00542607
Open Study to Evaluate the Safety of Levocetirizine in Young Children (2 - 6 Years) Suffering From Allergic Rhinitis
NCT00152412
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
LCTZ-LCTZ
Levocetirizine after having been randomized to Levocetirizine in the preceding A00309 trial - NCT00152464 (LCTZ-LCTZ)
LEVOCETIRIZINE
5mg/mL oral drops, 0.125 mg/kg body weight, bid for 18 months
LCTZ-PLC
Placebo after having been randomized to Levocetirizine in the preceding A00309 trial - NCT00152464 (LCTZ - PLC)
Placebo
Oral drops, bid for 18 months
PLC-PLC
Placebo after having been randomized to Placebo in the preceding A00309 trial - NCT00152464 (PLC-PLC)
Placebo
Oral drops, bid for 18 months
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
LEVOCETIRIZINE
5mg/mL oral drops, 0.125 mg/kg body weight, bid for 18 months
Placebo
Oral drops, bid for 18 months
Other Intervention Names
Discover alternative or legacy names that may be used to describe the listed interventions across different sources.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
Exclusion Criteria
30 Months
42 Months
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
UCB Pharma
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Isabelle Campine, MD
Role: STUDY_DIRECTOR
UCB Pharma
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
North Adelaide, , Australia
Parkville (North Melbourne), , Australia
Brussels, , Belgium
Brno, , Czechia
Hradec Králové, , Czechia
Olomouc, , Czechia
Ostrava, , Czechia
Plezen-Lochotin, , Czechia
Prague, , Czechia
Martigues, , France
Saint-Etienne, , France
Tarbes, , France
Toulouse, , France
Bayreuth, , Germany
Berlin, , Germany
Bielefeld, , Germany
Bochum, , Germany
Cologne, , Germany
Erlangen, , Germany
München, , Germany
Wesel, , Germany
Ancona, , Italy
Bari, , Italy
Bologna, , Italy
Messina, , Italy
Milan, , Italy
Napoli, , Italy
Pavia, , Italy
Roma, , Italy
Bialystock, , Poland
Gdansk, , Poland
Karpacz, , Poland
Lodz, , Poland
Lublin, , Poland
Rabka-Zdrój, , Poland
Warsaw, , Poland
Wroclaw, , Poland
Bellville, , South Africa
Clarement, , South Africa
Durban, , South Africa
Mowbray, , South Africa
Pietermaritzburg, , South Africa
Sydenham, , South Africa
West Honeydew, , South Africa
Westville, , South Africa
Wynberg, , South Africa
Barcelona, , Spain
Espluques de Llobreqat, , Spain
Dorchester, , United Kingdom
Enfield, , United Kingdom
Southampton, , United Kingdom
Countries
Review the countries where the study has at least one active or historical site.
Related Links
Access external resources that provide additional context or updates about the study.
For FDA Safety Alerts and Recalls refer to
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
A00384
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.