Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00160563
Recruitment Status : Terminated (The predecessor study A00309 (NCT00152464) did not show statistical significance in time to onset of asthma between the levocetirizine and placebo groups.)
First Posted : September 12, 2005
Results First Posted : August 4, 2009
Last Update Posted : March 3, 2015
Sponsor:
Information provided by (Responsible Party):
UCB Pharma

Tracking Information
First Submitted Date  ICMJE September 8, 2005
First Posted Date  ICMJE September 12, 2005
Results First Submitted Date  ICMJE June 17, 2009
Results First Posted Date  ICMJE August 4, 2009
Last Update Posted Date March 3, 2015
Study Start Date  ICMJE June 2004
Actual Primary Completion Date March 2006   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 7, 2009)
Time to Onset of Asthma [ Time Frame: 36 months (from the randomization visit to the preceding A00309 - NCT00152464 trial onwards.) ]
Original Primary Outcome Measures  ICMJE
 (submitted: September 8, 2005)
To assess the effect on the time to onset of asthma of 36-month treatment with Levocetirizine as compare to placebo, in asthma free young atopic children sensitized to Grass Pollen (GP) and/or House Dust Mite allergens (HDM).
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: August 7, 2009)
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.) ]
Original Secondary Outcome Measures  ICMJE
 (submitted: September 8, 2005)
  • To investigate the clinical benefit on the time to onset of asthma after 36-month of treatment in the LCTZ-LCTZ group as compared to LCTZ-PLC group.
  • To investigate whether the benefit on the time to onset of asthma after 18-month of treatment with LCTZ can be maintained over an additional 18-month period, once active treatment is stopped
  • To investigate the clinical benefit on the time to onset of asthma of an additional 18-month treatment period in the subset of subjects still asthma-free after the first 18-month treatment period.
  • To assess the safety of the long-term use of LCTZ in a large population of children aged between 30 and 60 months
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE 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  ICMJE 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.
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.

Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Asthma
Intervention  ICMJE
  • Drug: LEVOCETIRIZINE
    5mg/mL oral drops, 0.125 mg/kg body weight, bid for 18 months
    Other Name: Xyzal®
  • Other: Placebo
    Oral drops, bid for 18 months
Study Arms  ICMJE
  • Experimental: LCTZ-LCTZ
    Levocetirizine after having been randomized to Levocetirizine in the preceding A00309 trial - NCT00152464 (LCTZ-LCTZ)
    Intervention: Drug: LEVOCETIRIZINE
  • Placebo Comparator: LCTZ-PLC
    Placebo after having been randomized to Levocetirizine in the preceding A00309 trial - NCT00152464 (LCTZ - PLC)
    Intervention: Other: Placebo
  • Placebo Comparator: PLC-PLC
    Placebo after having been randomized to Placebo in the preceding A00309 trial - NCT00152464 (PLC-PLC)
    Intervention: Other: Placebo
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Terminated
Actual Enrollment  ICMJE
 (submitted: March 13, 2009)
207
Original Enrollment  ICMJE
 (submitted: September 8, 2005)
300
Actual Study Completion Date  ICMJE March 2006
Actual Primary Completion Date March 2006   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 30 Months to 42 Months   (Child)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Australia,   Belgium,   Czech Republic,   France,   Germany,   Italy,   Poland,   South Africa,   Spain,   United Kingdom
Removed Location Countries Austria
 
Administrative Information
NCT Number  ICMJE NCT00160563
Other Study ID Numbers  ICMJE A00384
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party UCB Pharma
Study Sponsor  ICMJE UCB Pharma
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Isabelle Campine, MD UCB Pharma
PRS Account UCB Pharma
Verification Date May 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP