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)

UCB

Status and phase: Terminated; Phase 3

Conditions: Asthma

Treatments: Other: Placebo; Drug: LEVOCETIRIZINE

Study type: Interventional

Funder types: Industry

Identifiers

NCT00160563

A00384

Details and patient eligibility

About

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.

Enrollment: 207 patients

Sex: All

Ages: 30 to 42 months old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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207 participants in 3 patient groups, including a placebo group

LCTZ-LCTZ

Experimental group

Description:

Levocetirizine after having been randomized to Levocetirizine in the preceding A00309 trial - NCT00152464 (LCTZ-LCTZ)

Treatment:

Drug: LEVOCETIRIZINE

LCTZ-PLC

Placebo Comparator group

Description:

Placebo after having been randomized to Levocetirizine in the preceding A00309 trial - NCT00152464 (LCTZ - PLC)

Treatment:

Other: Placebo

PLC-PLC

Placebo Comparator group

Description:

Placebo after having been randomized to Placebo in the preceding A00309 trial - NCT00152464 (PLC-PLC)

Treatment:

Other: Placebo