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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)

Primary Purpose

Asthma

Status
Terminated
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
LEVOCETIRIZINE
Placebo
Sponsored by
UCB Pharma
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Asthma focused on measuring Pediatry, EPAAC, atopic Children, prevention of asthma, Levocetirizine, Xyzal

Eligibility Criteria

30 Months - 42 Months (Child)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Placebo Comparator

Placebo Comparator

Arm Label

LCTZ-LCTZ

LCTZ-PLC

PLC-PLC

Arm Description

Levocetirizine after having been randomized to Levocetirizine in the preceding A00309 trial - NCT00152464 (LCTZ-LCTZ)

Placebo after having been randomized to Levocetirizine in the preceding A00309 trial - NCT00152464 (LCTZ - PLC)

Placebo after having been randomized to Placebo in the preceding A00309 trial - NCT00152464 (PLC-PLC)

Outcomes

Primary Outcome Measures

Time to Onset of Asthma

Secondary Outcome Measures

Time to Onset of Asthma in the Subset of Subjects Still Asthma Free After First 18 Months.

Full Information

First Posted
September 8, 2005
Last Updated
February 12, 2015
Sponsor
UCB Pharma
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1. Study Identification

Unique Protocol Identification Number
NCT00160563
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)
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

2. Study Status

Record Verification Date
May 2011
Overall Recruitment Status
Terminated
Why Stopped
The predecessor study A00309 (NCT00152464) did not show statistical significance in time to onset of asthma between the levocetirizine and placebo groups.
Study Start Date
June 2004 (undefined)
Primary Completion Date
March 2006 (Actual)
Study Completion Date
March 2006 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
UCB Pharma

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Asthma
Keywords
Pediatry, EPAAC, atopic Children, prevention of asthma, Levocetirizine, Xyzal

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
207 (Actual)

8. Arms, Groups, and Interventions

Arm Title
LCTZ-LCTZ
Arm Type
Experimental
Arm Description
Levocetirizine after having been randomized to Levocetirizine in the preceding A00309 trial - NCT00152464 (LCTZ-LCTZ)
Arm Title
LCTZ-PLC
Arm Type
Placebo Comparator
Arm Description
Placebo after having been randomized to Levocetirizine in the preceding A00309 trial - NCT00152464 (LCTZ - PLC)
Arm Title
PLC-PLC
Arm Type
Placebo Comparator
Arm Description
Placebo after having been randomized to Placebo in the preceding A00309 trial - NCT00152464 (PLC-PLC)
Intervention Type
Drug
Intervention Name(s)
LEVOCETIRIZINE
Other Intervention Name(s)
Xyzal®
Intervention Description
5mg/mL oral drops, 0.125 mg/kg body weight, bid for 18 months
Intervention Type
Other
Intervention Name(s)
Placebo
Intervention Description
Oral drops, bid for 18 months
Primary Outcome Measure Information:
Title
Time to Onset of Asthma
Time Frame
36 months (from the randomization visit to the preceding A00309 - NCT00152464 trial onwards.)
Secondary Outcome Measure Information:
Title
Time to Onset of Asthma in the Subset of Subjects Still Asthma Free After First 18 Months.
Time Frame
18 months (from the end of the preceding A00309 - NCT00152464 trial onwards.)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
30 Months
Maximum Age & Unit of Time
42 Months
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Isabelle Campine, MD
Organizational Affiliation
UCB Pharma
Official's Role
Study Director
Facility Information:
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

12. IPD Sharing Statement

Links:
URL
http://www.fda.gov/Safety/MedWatch/SafetyInformation/default.htm
Description
For FDA Safety Alerts and Recalls refer to

Learn more about this trial

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)

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