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)

February 12, 2015 updated by: UCB Pharma

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.

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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

207

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Australia
      • North Adelaide, Australia
      • Parkville (North Melbourne), Australia
  • Belgium
      • Bruxelles, Belgium
  • Czech Republic
      • Brno, Czech Republic
      • Hradec Kralove, Czech Republic
      • Olomouc, Czech Republic
      • Ostrava 9, Czech Republic
      • Plezen-Lochotin, Czech Republic
      • Praha 5, Czech Republic
      • Praha 8, Czech Republic
  • France
      • Martigues, France
      • Saint-Etienne Cedex 2, France
      • Tarbes Cedex, France
      • Toulouse Cedex 3, France
  • Germany
      • Bayreuth, Germany
      • Berlin, Germany
      • Bielefeld, Germany
      • Bochum, Germany
      • Erlangen, Germany
      • Koln, Germany
      • Munchen, Germany
      • Wesel, Germany
  • Italy
      • Ancona, Italy
      • Bari, Italy
      • Bologna, Italy
      • Messina, Italy
      • Milano, Italy
      • Napoli, Italy
      • Pavia, Italy
      • Roma, Italy
  • Poland
      • Bialystock, Poland
      • Gdansk, Poland
      • Karpacz, Poland
      • Lodz, Poland
      • Lublin, Poland
      • Rabka Zdroj, Poland
      • Warszawa, Poland
      • Wroclaw, Poland
  • South Africa
      • Bellville, South Africa
      • Clarement, South Africa
      • Durban, South Africa
      • Mowbray, South Africa
      • Pietermaritzburg, South Africa
      • Sydenham, South Africa
      • West Honeydew, South Africa
      • Westville, South Africa
      • Wynberg, South Africa
  • Spain
      • Barcelona, Spain
      • Espluques de Llobreqat, Spain
  • United Kingdom
      • Dorchester, United Kingdom
      • Enfield, United Kingdom
      • Southampton, United Kingdom

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

2 years to 3 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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 Names:
  • 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Time to Onset of Asthma
Time Frame: 36 months (from the randomization visit to the preceding A00309 - NCT00152464 trial onwards.)
36 months (from the randomization visit to the preceding A00309 - NCT00152464 trial onwards.)

Secondary Outcome Measures

Outcome Measure
Time Frame
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.)
18 months (from the end of the preceding A00309 - NCT00152464 trial onwards.)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

UCB Pharma

Investigators

  • Study Director: Isabelle Campine, MD, UCB Pharma

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2004

Primary Completion (Actual)

March 1, 2006

Study Completion (Actual)

March 1, 2006

Study Registration Dates

First Submitted

September 8, 2005

First Submitted That Met QC Criteria

September 8, 2005

First Posted (Estimate)

September 12, 2005

Study Record Updates

Last Update Posted (Estimate)

March 3, 2015

Last Update Submitted That Met QC Criteria

February 12, 2015

Last Verified

May 1, 2011

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • A00384

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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