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)

This study has been terminated.

( The predecessor study A00309 (NCT00152464) did not show statistical significance in time to onset of asthma between the levocetirizine and placebo groups. )

First Received on September 8, 2005. Last Updated on August 30, 2011 History of Changes

Sponsor:	UCB, Inc.
Information provided by (Responsible Party):	UCB, Inc.
ClinicalTrials.gov Identifier:	NCT00160563

Purpose

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.

Condition	Intervention	Phase
Asthma	Drug: LEVOCETIRIZINE Other: Placebo	Phase 3

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Treatment
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.

Resource links provided by NLM:

MedlinePlus related topics: Asthma

Drug Information available for: Levocetirizine Levocetirizine dihydrochloride

U.S. FDA Resources

Further study details as provided by UCB, Inc.:

Primary Outcome Measures:

Time to Onset of Asthma [ Time Frame: 36 months (from the randomization visit to the preceding A00309 - NCT00152464 trial onwards.) ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

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.) ] [ Designated as safety issue: No ]

Enrollment:	207
Study Start Date:	June 2004
Study Completion Date:	March 2006
Primary Completion Date:	March 2006 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: LCTZ-LCTZ Levocetirizine after having been randomized to Levocetirizine in the preceding A00309 trial - NCT00152464 (LCTZ-LCTZ)	Drug: LEVOCETIRIZINE 5mg/mL oral drops, 0.125 mg/kg body weight, bid for 18 months Other Name: Xyzal®
Placebo Comparator: LCTZ-PLC Placebo after having been randomized to Levocetirizine in the preceding A00309 trial - NCT00152464 (LCTZ - PLC)	Other: Placebo Oral drops, bid for 18 months
Placebo Comparator: PLC-PLC Placebo after having been randomized to Placebo in the preceding A00309 trial - NCT00152464 (PLC-PLC)	Other: Placebo Oral drops, bid for 18 months

Eligibility

Ages Eligible for Study:	30 Months to 42 Months
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00160563

Show 52 Study Locations

Sponsors and Collaborators

UCB, Inc.

Investigators

Study Director:

Isabelle Campine, MD

UCB, Inc.

More Information

Additional Information:

For FDA Safety Alerts and Recalls refer to This link exits the ClinicalTrials.gov site

Product Information This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party:	UCB, Inc.
ClinicalTrials.gov Identifier:	NCT00160563 History of Changes
Other Study ID Numbers:	A00384, EudraCT number 2004-000187-28
Study First Received:	September 8, 2005
Results First Received:	June 17, 2009
Last Updated:	August 30, 2011
Health Authority:	France: Afssaps - French Health Products Safety Agency Italy: Ministry of Health Germany: Federal Institute for Drugs and Medical Devices Czech Republic: State Institute for Drug Control Poland: Ministry of Health Spain: Ministry of Health and Consumption South Africa: Medicines Control Council Australia: Department of Health and Ageing Therapeutic Goods Administration Belgium: Directorate general for the protection of Public health: Medicines United Kingdom: Medicines and Healthcare Products Regulatory Agency

Keywords provided by UCB, Inc.:

Pediatry
EPAAC
atopic Children

prevention of asthma
Levocetirizine
Xyzal

Additional relevant MeSH terms:

Asthma
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases
Levocetirizine
Cetirizine

Histamine H1 Antagonists, Non-Sedating
Histamine H1 Antagonists
Histamine Antagonists
Histamine Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs
Anti-Allergic Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on May 24, 2012