Ignite Creation Date:
2024-05-05 @ 11:53 AM
Last Modification Date:
2024-10-26 @ 9:15 AM
Study NCT ID:
NCT00160563
Status:
TERMINATED
Last Update Posted:
2015-03-03
First Post:
2005-09-08
Brief Title:
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
Sponsor:
UCB Pharma
Organization:
UCB Pharma
Study Overview
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 mgml Oral Drops -0125 mgkg bw bid Administered for an Additional 18 Months Period in Preventing the Onset of Asthma in Children Coming From the EPAAC Trial
Status:
TERMINATED
Status Verified Date:
2011-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
The predecessor study A00309 NCT00152464 did not show statistical significance in time to onset of asthma between the levocetirizine and placebo groups
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
36 months study to evaluate the efficacy and safety of levocetirizine LCTZ in preventing the onset of asthma in young atopic children
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None