Trials / Terminated
TerminatedNCT00160563
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)
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.
- Status
- Terminated
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 207 (actual)
- Sponsor
- UCB Pharma · Industry
- Sex
- All
- Age
- 30 Months – 42 Months
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | LEVOCETIRIZINE | 5mg/mL oral drops, 0.125 mg/kg body weight, bid for 18 months |
| OTHER | Placebo | Oral drops, bid for 18 months |
Timeline
- Start date
- 2004-06-01
- Primary completion
- 2006-03-01
- Completion
- 2006-03-01
- First posted
- 2005-09-12
- Last updated
- 2015-03-03
- Results posted
- 2009-08-04
Locations
51 sites across 10 countries: Australia, Belgium, Czechia, France, Germany, Italy, Poland, South Africa, Spain, United Kingdom
Source: ClinicalTrials.gov record NCT00160563. Inclusion in this directory is not an endorsement.