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)

NCT00160563 | Terminated Phase 3 Results

• 1 other identifier: A00384
• Study Type: interventional
• Target: 207
• Locations: 10 countries
• Sites: 51

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.

Conditions

Asthma

Keywords

Pediatry; EPAAC; atopic Children; prevention of asthma; Levocetirizine; Xyzal

Outcome Measures

Primary Outcomes (1)

• Time to Onset of Asthma

  36 months (from the randomization visit to the preceding A00309 - NCT00152464 trial onwards.)

Secondary Outcomes (1)

• 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.)

Study Arms (3)

LCTZ-LCTZ

EXPERIMENTAL

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

Drug: LEVOCETIRIZINE

LCTZ-PLC

PLACEBO COMPARATOR

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

Other: Placebo

PLC-PLC

PLACEBO COMPARATOR

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

Other: Placebo

Interventions

LEVOCETIRIZINE DRUG

5mg/mL oral drops, 0.125 mg/kg body weight, bid for 18 months

Also known as: Xyzal®

LCTZ-LCTZ

Placebo OTHER

Oral drops, bid for 18 months

LCTZ-PLC; PLC-PLC

Eligibility Criteria

• Age: 30 Months - 42 Months
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Having completed the previous 18-month treatment period of the EPAAC trial - NCT00152464

You may not qualify if:

• None

Sponsors & Collaborators

• UCB Pharma: lead

Study Sites (51)

Unknown Facility

North Adelaide, Australia

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Parkville (North Melbourne), Australia

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Brussels, Belgium

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Brno, Czechia

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Hradec Králové, Czechia

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Olomouc, Czechia

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Ostrava, Czechia

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Plezen-Lochotin, Czechia

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Prague, Czechia

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Martigues, France

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Saint-Etienne, France

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Tarbes, France

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Toulouse, France

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Bayreuth, Germany

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Berlin, Germany

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Bielefeld, Germany

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Bochum, Germany

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Cologne, Germany

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Erlangen, Germany

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München, Germany

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Wesel, Germany

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Ancona, Italy

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Bari, Italy

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Bologna, Italy

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Messina, Italy

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Milan, Italy

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Napoli, Italy

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Pavia, Italy

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Roma, Italy

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Bialystock, Poland

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Gdansk, Poland

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Karpacz, Poland

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Lodz, Poland

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Lublin, Poland

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Rabka-Zdrój, Poland

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Warsaw, Poland

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Wroclaw, Poland

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Bellville, South Africa

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Clarement, South Africa

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Durban, South Africa

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Mowbray, South Africa

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Pietermaritzburg, South Africa

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Sydenham, South Africa

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West Honeydew, South Africa

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Westville, South Africa

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Wynberg, South Africa

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Barcelona, Spain

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Espluques de Llobreqat, Spain

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Dorchester, United Kingdom

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Enfield, United Kingdom

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Southampton, United Kingdom

Location

Related Links

• For FDA Safety Alerts and Recalls refer to

MeSH Terms

Conditions

Asthma

Interventions

levocetirizine

Condition Hierarchy (Ancestors)

Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Results Point of Contact

• Title: UCB Clinical Trial Call Center
• Organization: UCB Pharma

+1 877 822 9493

Study Officials

• Isabelle Campine, MD

  UCB Pharma

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• 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 12, 2005
• Study Start: June 1, 2004
• Primary Completion: March 1, 2006
• Study Completion: March 1, 2006
• Last Updated: March 3, 2015
• Results First Posted: August 4, 2009

Record last verified: 2011-05

Locations

PL (8); AU (2); FR (4); ZA (9); ES (2); BE (1); IT (8); GB (3); CZ (6); DE (8)