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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)

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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

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.


Condition or disease Intervention/treatment Phase
Asthma Drug: LEVOCETIRIZINE Other: Placebo Phase 3

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 207 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, 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.
Study Start Date : June 2004
Actual Primary Completion Date : March 2006
Actual Study Completion Date : March 2006

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Asthma

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 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




Primary Outcome Measures :
  1. Time to Onset of Asthma [ Time Frame: 36 months (from the randomization visit to the preceding A00309 - NCT00152464 trial onwards.) ]

Secondary Outcome Measures :
  1. 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.) ]


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Ages Eligible for Study:   30 Months to 42 Months   (Child)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00160563


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Sponsors and Collaborators
UCB Pharma
Investigators
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Study Director: Isabelle Campine, MD UCB Pharma

Additional Information:
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Responsible Party: UCB Pharma
ClinicalTrials.gov Identifier: NCT00160563     History of Changes
Other Study ID Numbers: A00384
First Posted: September 12, 2005    Key Record Dates
Results First Posted: August 4, 2009
Last Update Posted: March 3, 2015
Last Verified: May 2011
Keywords provided by UCB Pharma:
Pediatry
EPAAC
atopic Children
prevention of asthma
Levocetirizine
Xyzal
Additional relevant MeSH terms:
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Asthma
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases
Cetirizine
Levocetirizine
Histamine H1 Antagonists, Non-Sedating
Histamine H1 Antagonists
Histamine Antagonists
Histamine Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Anti-Allergic Agents