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)
- Registration Number
- NCT00160563
- Lead Sponsor
- UCB Pharma
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 207
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description LCTZ-PLC Placebo Placebo after having been randomized to Levocetirizine in the preceding A00309 trial - NCT00152464 (LCTZ - PLC) PLC-PLC Placebo Placebo after having been randomized to Placebo in the preceding A00309 trial - NCT00152464 (PLC-PLC) LCTZ-LCTZ LEVOCETIRIZINE Levocetirizine after having been randomized to Levocetirizine in the preceding A00309 trial - NCT00152464 (LCTZ-LCTZ)
- Primary Outcome Measures
Name Time Method Time to Onset of Asthma 36 months (from the randomization visit to the preceding A00309 - NCT00152464 trial onwards.)
- Secondary Outcome Measures
Name Time Method Time to Onset of Asthma in the Subset of Subjects Still Asthma Free After First 18 Months. 18 months (from the end of the preceding A00309 - NCT00152464 trial onwards.)
Related Research Topics
Explore scientific publications, clinical data analysis, treatment approaches, and expert-compiled information related to the mechanisms and outcomes of this trial. Click any topic for comprehensive research insights.
What molecular mechanisms underlie Levocetirizine's efficacy in preventing asthma in atopic children with grass pollen and house dust mite sensitization?
How does Levocetirizine compare to standard-of-care antihistamines in long-term asthma prevention for eczema-sensitized pediatric patients?
Which biomarkers correlate with asthma onset prevention in NCT00160563's 36-month Levocetirizine trial for atopic dermatitis patients?
What are the long-term adverse event profiles of Levocetirizine in young children with atopic dermatitis and allergen sensitization?
Are there combination therapies or competitor drugs targeting Th2 inflammation for asthma prevention in atopic children similar to NCT00160563's approach?