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: September 8, 2005 Last Updated: December 23, 2009 History of Changes

Sponsor:	UCB, Inc.
Information provided by:	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 III

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Safety/Efficacy Study
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
LCTZ-LCTZ: Experimental 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
LCTZ-PLC: Placebo Comparator Placebo after having been randomized to Levocetirizine in the preceding A00309 trial - NCT00152464 (LCTZ - PLC)	Other: Placebo Oral drops, bid for 18 months
PLC-PLC: Placebo Comparator 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 ( Study Director )
Study ID Numbers:	A00384, EudraCT number 2004-000187-28
Study First Received:	September 8, 2005
Results First Received:	June 17, 2009
Last Updated:	December 23, 2009
ClinicalTrials.gov Identifier:	NCT00160563 History of Changes
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:

Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Bronchial Diseases
Immune System Diseases
Physiological Effects of Drugs
Histamine Agents
Asthma
Anti-Allergic Agents
Cetirizine
Pharmacologic Actions
Lung Diseases, Obstructive

Hypersensitivity
Histamine Antagonists
Respiratory Tract Diseases
Levocetirizine
Therapeutic Uses
Lung Diseases
Hypersensitivity, Immediate
Histamine H1 Antagonists
Histamine H1 Antagonists, Non-Sedating
Respiratory Hypersensitivity

ClinicalTrials.gov processed this record on February 08, 2010