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)

This study has been terminated.

( The predecessor study A00309 (NCT00152464) did not show statistical significance in time to onset of asthma between the levocetirizine and placebo groups. )

Study NCT00160563 Information provided by UCB, Inc.

First Received on September 8, 2005. Last Updated on August 30, 2011 History of Changes

Results First Received: June 17, 2009

Study Type:	Interventional
Study Design:	Allocation: Randomized; Endpoint Classification: Safety/Efficacy Study; Intervention Model: Parallel Assignment; Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor); Primary Purpose: Treatment
Condition:	Asthma
Interventions:	Drug: LEVOCETIRIZINE Other: Placebo

Participant Flow

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Recruitment Details

Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
This study is a 18-month prolongation study to study A00309 (EPAAC study - NCT00152464) and was prematurely terminated due to the fact that the primary endpoint in study A00309 - NCT00152464 was not met.

Pre-Assignment Details

Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
In total, 207 subjects from study A00309 - NCT00152464 entered this prolongation study. Participants Flow and Baseline Characteristics sections show patients as randomized. One patient (016/1709) received LCTZ instead of PLC in the PLC-PLC arm erroneously and is described separately in the Adverse Event section.

Reporting Groups

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

Participant Flow: Overall Study

	LCTZ-LCTZ	LCTZ-PLC	PLC-PLC
STARTED	59	47	101
COMPLETED	8	2	11
NOT COMPLETED	51	45	90
Adverse Event	1	1	1
Lost to Follow-up	1	1	2
Protocol Violation	0	0	3
Withdrawal by Subject	1	2	3
Other (listed in the study report)	48	40	81
Missing reason	0	1	0

Baseline Characteristics

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Reporting Groups

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

Baseline Measures

	LCTZ-LCTZ	LCTZ-PLC	PLC-PLC	Total
Number of Participants [units: participants]	59	47	101	207
Age [units: months] Mean ± Standard Deviation	19.6 ± 3.58	18.9 ± 4.08	19.2 ± 4.10	19.2 ± 3.94
Gender [units: participants]
Female	23	25	38	86
Male	36	22	63	121
Region of Enrollment [units: participants]
France	2	3	9	14
Czech Republic	9	8	17	34
Poland	11	9	18	38
Spain	0	1	2	3
Belgium	3	0	1	4
Australia	2	3	2	7
South Africa	15	10	22	47
Germany	9	4	13	26
Italy	6	7	13	26
United Kingdom	2	2	4	8

Outcome Measures

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1. Primary:

Time to Onset of Asthma [ Time Frame: 36 months (from the randomization visit to the preceding A00309 - NCT00152464 trial onwards.) ]

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2. Secondary:

Time to Onset of Asthma in the Subset of Subjects Still Asthma Free After First 18 Months. [ Time Frame: 18 months (from the end of the preceding A00309 - NCT00152464 trial onwards.) ]

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Serious Adverse Events

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Other Adverse Events

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More Information

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Certain Agreements:

Principal Investigators are NOT employed by the organization sponsoring the study.

There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.

The agreement is:

	The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
	The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
	Other disclosure agreement that restricts the right of the PI to discuss or publish trial results after the trial is completed. Restriction Description: UCB has > 60 days but <= 180 days to review results communications prior to public release and may delete information that compromises ongoing studies or is considered proprietary. This restriction is not intended to compromise the objective scientific integrity of the manuscript, it being understood that results shall be published regardless of outcome.

Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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Results Point of Contact:

Name/Title: UCB Clinical Trial Call Center
Organization: UCB Pharma
phone: +1 877 822 9493

No publications provided

Responsible Party:	UCB, Inc.
ClinicalTrials.gov Identifier:	NCT00160563 History of Changes
Other Study ID Numbers:	A00384, EudraCT number 2004-000187-28
Study First Received:	September 8, 2005
Results First Received:	June 17, 2009
Last Updated:	August 30, 2011
Health Authority:	France: Afssaps - French Health Products Safety Agency; Italy: Ministry of Health; Germany: Federal Institute for Drugs and Medical Devices; Czech Republic: State Institute for Drug Control; Poland: Ministry of Health; Spain: Ministry of Health and Consumption; South Africa: Medicines Control Council; Australia: Department of Health and Ageing Therapeutic Goods Administration; Belgium: Directorate general for the protection of Public health: Medicines; United Kingdom: Medicines and Healthcare Products Regulatory Agency