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)

NCT00152464 | Completed Phase 3 Results

• 1 other identifier: A00309
• Study Type: interventional
• Target: 514
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Dermatitis, Atopic

Keywords

EPAAC; Atopic children; Asthma; XYZAL; Levocetirizine

Outcome Measures

Primary Outcomes (1)

• Time to Onset of Asthma During the Treatment Period

  The time to onset of asthma was defined as the period elapsed between the randomization visit (V2) and the date of onset of asthma. Instead of the median the first Quartile is reported since the median (50%) was not reached.

  During the treatment period (18 months)

Secondary Outcomes (9)

• Percentage of Days With Symptoms of Either Wheezing or Nocturnal Cough

  During the treatment period (18 months)

• Percentage of Days With Symptoms of Wheezing

  During the treatment period (18 months)

• Percentage of Days With Symptoms of Nocturnal Cough

  During the treatment period (18 months)

• Percentage of Subjects Using Asthma Medication

  During the treatment period (18 months)

• Percentage of Days of Use of Asthma Medication

  During the treatment period (18 months)

Study Arms (2)

Levocetirizine (LCTZ)

EXPERIMENTAL

0.125 mg/kg of Levocetirizine (LCTZ) were administered as oral drops twice daily.

Drug: Levocetirizine

Placebo (PBO)

PLACEBO COMPARATOR

Placebo was administered as oral drops twice daily.

Drug: Placebo

Interventions

Placebo DRUG

Pharmaceutical form: Oral drops Route of administration: Oral use

Placebo (PBO)

Levocetirizine DRUG

Pharmaceutical form: Oral drops Concentration: 5 mg/ml Route of administration: Oral use

Also known as: Xyzal

Levocetirizine (LCTZ)

Eligibility Criteria

• Age: 12 Months - 24 Months
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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 Severity Scoring of Atopic Dermatitis (SCORAD) Index \>= 10
• Subjects whose biological mother or father, or one sibling has a well-documented history of atopy (AD, allergic rhinitis or asthma)
• Results of the Radio-allergosorbant (RAST) test for grass pollen (GP) and house dust mite (HDM) are available and Immunoglobulin E (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

You may not qualify if:

• 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,

Sponsors & Collaborators

• UCB Pharma SA: lead

Related Links

• FDA Safety Alerts and Recalls

MeSH Terms

Conditions

Dermatitis, Atopic; Asthma

Interventions

levocetirizine

Condition Hierarchy (Ancestors)

Skin Diseases, Genetic; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Dermatitis; Skin Diseases; Skin and Connective Tissue Diseases; Skin Diseases, Eczematous; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases; Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases; Respiratory Hypersensitivity

Results Point of Contact

• Title: UCB
• Organization: Cares

UCBCares@ucb.com

+1844 599

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: GT60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 8, 2005
• First Posted: September 9, 2005
• Study Start: March 20, 2002
• Primary Completion: March 15, 2006
• Study Completion: March 15, 2006
• Last Updated: January 22, 2019
• Results First Posted: January 22, 2019

Record last verified: 2018-08