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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/NCT00160563




Registration number
NCT00160563
Ethics application status
Date submitted
8/09/2005
Date registered
12/09/2005
Date last updated
3/03/2015

Titles & IDs
Public title
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)
Scientific 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.
Secondary ID [1] 0 0
A00384
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Asthma 0 0
Condition category
Condition code
Respiratory 0 0 0 0
Asthma

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - LEVOCETIRIZINE
Other interventions - Placebo

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

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

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


Treatment: Drugs: LEVOCETIRIZINE
5mg/mL oral drops, 0.125 mg/kg body weight, bid for 18 months

Other interventions: Placebo
Oral drops, bid for 18 months

Intervention code [1] 0 0
Treatment: Drugs
Intervention code [2] 0 0
Other interventions
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Time to Onset of Asthma
Timepoint [1] 0 0
36 months (from the randomization visit to the preceding A00309 - NCT00152464 trial onwards.)
Secondary outcome [1] 0 0
Time to Onset of Asthma in the Subset of Subjects Still Asthma Free After First 18 Months.
Timepoint [1] 0 0
18 months (from the end of the preceding A00309 - NCT00152464 trial onwards.)

Eligibility
Key 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
Minimum age
30 Months
Maximum age
42 Months
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
- None

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint(s)
Statistical methods / analysis

Recruitment
Recruitment status
Terminated
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
- North Adelaide
Recruitment hospital [2] 0 0
- Parkville (North Melbourne)
Recruitment postcode(s) [1] 0 0
- North Adelaide
Recruitment postcode(s) [2] 0 0
- Parkville (North Melbourne)
Recruitment outside Australia
Country [1] 0 0
Belgium
State/province [1] 0 0
Bruxelles
Country [2] 0 0
Czech Republic
State/province [2] 0 0
Brno
Country [3] 0 0
Czech Republic
State/province [3] 0 0
Hradec Kralove
Country [4] 0 0
Czech Republic
State/province [4] 0 0
Olomouc
Country [5] 0 0
Czech Republic
State/province [5] 0 0
Ostrava 9
Country [6] 0 0
Czech Republic
State/province [6] 0 0
Plezen-Lochotin
Country [7] 0 0
Czech Republic
State/province [7] 0 0
Praha 5
Country [8] 0 0
Czech Republic
State/province [8] 0 0
Praha 8
Country [9] 0 0
France
State/province [9] 0 0
Martigues
Country [10] 0 0
France
State/province [10] 0 0
Saint-Etienne Cedex 2
Country [11] 0 0
France
State/province [11] 0 0
Tarbes Cedex
Country [12] 0 0
France
State/province [12] 0 0
Toulouse Cedex 3
Country [13] 0 0
Germany
State/province [13] 0 0
Bayreuth
Country [14] 0 0
Germany
State/province [14] 0 0
Berlin
Country [15] 0 0
Germany
State/province [15] 0 0
Bielefeld
Country [16] 0 0
Germany
State/province [16] 0 0
Bochum
Country [17] 0 0
Germany
State/province [17] 0 0
Erlangen
Country [18] 0 0
Germany
State/province [18] 0 0
Koln
Country [19] 0 0
Germany
State/province [19] 0 0
Munchen
Country [20] 0 0
Germany
State/province [20] 0 0
Wesel
Country [21] 0 0
Italy
State/province [21] 0 0
Ancona
Country [22] 0 0
Italy
State/province [22] 0 0
Bari
Country [23] 0 0
Italy
State/province [23] 0 0
Bologna
Country [24] 0 0
Italy
State/province [24] 0 0
Messina
Country [25] 0 0
Italy
State/province [25] 0 0
Milano
Country [26] 0 0
Italy
State/province [26] 0 0
Napoli
Country [27] 0 0
Italy
State/province [27] 0 0
Pavia
Country [28] 0 0
Italy
State/province [28] 0 0
Roma
Country [29] 0 0
Poland
State/province [29] 0 0
Bialystock
Country [30] 0 0
Poland
State/province [30] 0 0
Gdansk
Country [31] 0 0
Poland
State/province [31] 0 0
Karpacz
Country [32] 0 0
Poland
State/province [32] 0 0
Lodz
Country [33] 0 0
Poland
State/province [33] 0 0
Lublin
Country [34] 0 0
Poland
State/province [34] 0 0
Rabka Zdroj
Country [35] 0 0
Poland
State/province [35] 0 0
Warszawa
Country [36] 0 0
Poland
State/province [36] 0 0
Wroclaw
Country [37] 0 0
South Africa
State/province [37] 0 0
Bellville
Country [38] 0 0
South Africa
State/province [38] 0 0
Clarement
Country [39] 0 0
South Africa
State/province [39] 0 0
Durban
Country [40] 0 0
South Africa
State/province [40] 0 0
Mowbray
Country [41] 0 0
South Africa
State/province [41] 0 0
Pietermaritzburg
Country [42] 0 0
South Africa
State/province [42] 0 0
Sydenham
Country [43] 0 0
South Africa
State/province [43] 0 0
West Honeydew
Country [44] 0 0
South Africa
State/province [44] 0 0
Westville
Country [45] 0 0
South Africa
State/province [45] 0 0
Wynberg
Country [46] 0 0
Spain
State/province [46] 0 0
Barcelona
Country [47] 0 0
Spain
State/province [47] 0 0
Espluques de Llobreqat
Country [48] 0 0
United Kingdom
State/province [48] 0 0
Dorchester
Country [49] 0 0
United Kingdom
State/province [49] 0 0
Enfield
Country [50] 0 0
United Kingdom
State/province [50] 0 0
Southampton

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
UCB Pharma
Address
Country

Ethics approval
Ethics application status

Summary
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.
Trial website
https://clinicaltrials.gov/show/NCT00160563
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Isabelle Campine, MD
Address 0 0
UCB Pharma
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Summary results
For IPD and results data, please see https://clinicaltrials.gov/show/NCT00160563