Prevention of Asthma With Levocetirizine 18 Month Treatment in Infants (12 - 24 Months) Suffering From Eczema (Atopic Dermatitis) and Sensitized to Grass Pollen and/or House Dust Mite (HDM)

This study has been completed.
Sponsor:
Information provided by:
UCB, Inc.
ClinicalTrials.gov Identifier:
NCT00152464
First received: September 8, 2005
Last updated: December 13, 2013
Last verified: September 2009
  Purpose

The Early Prevention of Asthma in Atopic Children (EPAAC™) . 24 months study to evaluate the efficacy and safety of levocetirizine (LCTZ) in preventing the onset of asthma in 12 to 24 months old children.


Condition Intervention Phase
Dermatitis, Atopic
Drug: LEVOCETIRIZINE
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double-Blind
Official Title: The Early Prevention of Asthma in Atopic Children (EPAAC™) Study. A Multi-country, Double Blind, Placebo (PLC) Controlled, Randomized, Parallel Group Trial: Evaluation of the Efficacy and Safety of Levocetirizine (LCTZ) (5 mg/ml Oral Drops -0.125 mg/kg b.w. b.i.d.) Administered for 18 Months in Preventing the Onset of Asthma in 12 to 24 Months Old Children Who Suffer From Atopic Dermatitis and Are Sensitized to Grass Pollen and / or House Dust Mite Allergens.

Resource links provided by NLM:


Further study details as provided by UCB, Inc.:

Primary Outcome Measures:
  • Compare the effect of LCTZ and PLC on the time to onset of asthma after 18 months of treatment, in asthma free young atopic children sensitized to Grass Pollen (GP) and/or House Dust Mite allergens (HDM).

Secondary Outcome Measures:
  • Compare the symptoms and medications used for asthma; investigate consistency of treatment effect found overall on the time to onset of asthma during treatment period; Assess safety of long-term use of LCTZ in a large population of children.

Estimated Enrollment: 2500
Study Start Date: March 2002
Study Completion Date: March 2006
Primary Completion Date: March 2006 (Final data collection date for primary outcome measure)
  Eligibility

Ages Eligible for Study:   12 Months to 24 Months
Genders Eligible for Study:   Both
Criteria

Inclusion Criteria:

  • Inclusion criteria which must be verified during screening visit (V1):

    • Children of either sex aged between 12 and 24 months.
    • Subjects suffering from symptoms of Atopic Dermatitis (AD) lasting cumulatively for at least 2 months since birth.
    • Modified SCORAD Index ≥ 10
    • Subjects whose biological mother or father, or one sibling has a well-documented history of atopy (AD, allergic rhinitis or asthma).

Inclusion criteria which must be verified during randomization (V2):

  • Results of the RAST test for GP and HDM are available and IgE level against GP ≥ 0.35 kUA/l and / or IgE level against HDM ≥ 0.35 kUA/l.
  • Safety laboratory results are within the normal range of the central laboratory or considered as not clinically significant or study disease related by the Investigator.

Exclusion Criteria:

  • Exclusion criteria to verify at screening visit (V1):

Are to be excluded from the participation in the study, those children who

  • Have height or weight below the 5th percentile.
  • Have experienced at least one episode of wheezing when aged 6 months or over.
  • Have suffered at age 6 months or over, from at least one nocturnal cough episode consisting of 3 (or more) consecutive nights resulting in sleep disturbances in a clinical setting where asthma is likely and other conditions have been excluded.
  • Have chronic pulmonary diseases of any type, such as, but not limited to, cystic fibrosis, or any cranio-facial abnormality, e.g., cleft palate.
  • Have a personal history of sleep apnea or who have siblings with a history of sleep apnea.
  • Are treated with any immunomodulator medication such as, e.g., cyclosporin, cyclophosphamide or FK 506 (Tacrolimus).
  • Have received or are receiving allergen - specific immunotherapy.
  • Suffer from concomitant dermatological disease/condition other than atopic dermatitis, that might interfere with the evaluation of the clinical response for atopic dermatitis.
  • Have an insufficient wash-out period for the following medications:
  • Intranasal or systemic antihistamines: 3 days,
  • Intranasal or systemic decongestants: 3 days,
  • Loratadine, Desloratadine: 10 days,
  • Chromones: 2 weeks,
  • Oral corticosteroids: 1 month,
  • Chronic use (i.e. cumulatively up to 2 weeks within the last 3 months) of inhaled/intranasal corticosteroids: 1 month,
  • Ketotifen: 1 month,
  • Astemizole: 6 weeks
  • Have been treated with any antihistamine, including ketotifen, with daily intake for more than 2 consecutive months in the last 6 months before screening.

Subject Exclusion criteria to verify at randomization visit (V2):

• Intake of any prohibited medication listed above during the selection period.

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00152464

Sponsors and Collaborators
UCB, Inc.
Investigators
Study Director: UCB Clinical Trial Call Center UCB, Inc.
  More Information

Additional Information:
No publications provided

ClinicalTrials.gov Identifier: NCT00152464     History of Changes
Other Study ID Numbers: A00309
Study First Received: September 8, 2005
Last Updated: December 13, 2013
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
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: Federal Agency for Medicines and Health Products, FAMHP
United Kingdom: Medicines and Healthcare Products Regulatory Agency
Austria: Federal Ministry for Health and Women
Netherlands: Medicines Evaluation Board (MEB)

Keywords provided by UCB, Inc.:
EPAAC , atopic Children, asthma, XYZAL, levocetirizine

Additional relevant MeSH terms:
Asthma
Dermatitis
Dermatitis, Atopic
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases
Skin Diseases
Skin Diseases, Genetic
Genetic Diseases, Inborn
Skin Diseases, Eczematous
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 July 23, 2014