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NCT00160563 Clinical Trial

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)

Asthma Clinical Trial

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.

Clinical Trial Details — Status: Terminated

Administrative data
NCT number NCT00160563
Other study ID # A00384
Secondary ID
Status Terminated
Phase Phase 3
First received September 8, 2005
Last updated February 12, 2015
Start date June 2004
Est. completion date March 2006

Study information
Verified date May 2011
Source UCB Pharma
Contact n/a
Is FDA regulated No
Health authority France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)Italy: Ministry of HealthGermany: Federal Institute for Drugs and Medical DevicesCzech Republic: State Institute for Drug ControlPoland: Ministry of HealthSpain: Ministry of Health and ConsumptionSouth Africa: Medicines Control CouncilAustralia: Department of Health and Ageing Therapeutic Goods AdministrationBelgium: Federal Agency for Medicines and Health Products, FAMHPUnited Kingdom: Medicines and Healthcare Products Regulatory Agency
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Terminated
Enrollment 207
Est. completion date March 2006
Est. primary completion date March 2006
Accepts healthy volunteers No
Gender Both
Age group 30 Months to 42 Months
Eligibility 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:

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Drug:
• LEVOCETIRIZINE
5mg/mL oral drops, 0.125 mg/kg body weight, bid for 18 months
Other:
• Placebo
Oral drops, bid for 18 months

Locations
Country Name City State
n/a

Sponsors (1)
Lead Sponsor Collaborator
UCB Pharma

Countries where clinical trial is conducted

Australia,  Belgium,  Czech Republic,  France,  Germany,  Italy,  Poland,  South Africa,  Spain,  United Kingdom, 

Outcome
Type Measure Description Time frame Safety issue
Primary Time to Onset of Asthma 36 months (from the randomization visit to the preceding A00309 - NCT00152464 trial onwards.) No
Secondary Time to Onset of Asthma in the Subset of Subjects Still Asthma Free After First 18 Months. 18 months (from the end of the preceding A00309 - NCT00152464 trial onwards.) No
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