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Trial record 1 of 1 for:    NCT00160563
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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)

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ClinicalTrials.gov Identifier: NCT00160563
Recruitment Status : Terminated (The predecessor study A00309 (NCT00152464) did not show statistical significance in time to onset of asthma between the levocetirizine and placebo groups.)
First Posted : September 12, 2005
Results First Posted : August 4, 2009
Last Update Posted : March 3, 2015
Sponsor:
Information provided by (Responsible Party):
UCB Pharma

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition Asthma
Interventions Drug: LEVOCETIRIZINE
Other: Placebo
Enrollment 207
Recruitment Details 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 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.
Arm/Group Title LCTZ-LCTZ LCTZ-PLC PLC-PLC
Hide Arm/Group Description Levocetirizine after having been randomized to Levocetirizine in the preceding A00309 trial (LCTZ-LCTZ) Placebo after having been randomized to Levocetirizine in the preceding A00309 trial (LCTZ - PLC) Placebo after having been randomized to Placebo in the preceding A00309 trial (PLC-PLC)
Period Title: Overall Study
Started 59 47 101
Completed 8 2 11
Not Completed 51 45 90
Reason Not Completed
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
Arm/Group Title LCTZ-LCTZ LCTZ-PLC PLC-PLC Total
Hide Arm/Group Description Levocetirizine after having been randomized to Levocetirizine in the preceding A00309 trial (LCTZ-LCTZ) Placebo after having been randomized to Levocetirizine in the preceding A00309 trial (LCTZ - PLC) Placebo after having been randomized to Placebo in the preceding A00309 trial (PLC-PLC) Total of all reporting groups
Overall Number of Baseline Participants 59 47 101 207
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Months
Number Analyzed 59 participants 47 participants 101 participants 207 participants
19.6  (3.58) 18.9  (4.08) 19.2  (4.10) 19.2  (3.94)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 59 participants 47 participants 101 participants 207 participants
Female
23
  39.0%
25
  53.2%
38
  37.6%
86
  41.5%
Male
36
  61.0%
22
  46.8%
63
  62.4%
121
  58.5%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 59 participants 47 participants 101 participants 207 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
1.Primary Outcome
Title Time to Onset of Asthma
Hide Description [Not Specified]
Time Frame 36 months (from the randomization visit to the preceding A00309 - NCT00152464 trial onwards.)
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis was not performed due to premature discontinuation of the study.
Arm/Group Title LCTZ-LCTZ LCTZ-PLC PLC-PLC
Hide Arm/Group Description:
Levocetirizine after having been randomized to Levocetirizine in the preceding A00309 trial (LCTZ-LCTZ)
Placebo after having been randomized to Levocetirizine in the preceding A00309 trial (LCTZ - PLC)
Placebo after having been randomized to Placebo in the preceding A00309 trial (PLC-PLC)
Overall Number of Participants Analyzed 0 0 0
No data displayed because Outcome Measure has zero total analyzed.
2.Secondary Outcome
Title Time to Onset of Asthma in the Subset of Subjects Still Asthma Free After First 18 Months.
Hide Description [Not Specified]
Time Frame 18 months (from the end of the preceding A00309 - NCT00152464 trial onwards.)
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis was not performed due to premature discontinuation of the study.
Arm/Group Title LCTZ-LCTZ LCTZ-PLC PLC-PLC
Hide Arm/Group Description:
Levocetirizine after having been randomized to Levocetirizine in the preceding A00309 trial (LCTZ-LCTZ)
Placebo after having been randomized to Levocetirizine in the preceding A00309 trial (LCTZ - PLC)
Placebo after having been randomized to Placebo in the preceding A00309 trial (PLC-PLC)
Overall Number of Participants Analyzed 0 0 0
No data displayed because Outcome Measure has zero total analyzed.
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title LCTZ-LCTZ LCTZ-PLC PLC-PLC PLC-LCTZ
Hide Arm/Group Description Levocetirizine after having been randomized to Levocetirizine in the preceding A00309 trial (LCTZ-LCTZ) Placebo after having been randomized to Levocetirizine in the preceding A00309 trial (LCTZ - PLC) Placebo after having been randomized to Placebo in the preceding A00309 trial (PLC-PLC) Levocetirizine after having been randomized to Placebo in the preceding A00309 trial (PLC-LCTZ) erroneously (Patient 016/1709)
All-Cause Mortality
LCTZ-LCTZ LCTZ-PLC PLC-PLC PLC-LCTZ
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--      --/--      --/--    
Hide Serious Adverse Events
LCTZ-LCTZ LCTZ-PLC PLC-PLC PLC-LCTZ
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   5/59 (8.47%)      3/47 (6.38%)      3/100 (3.00%)      0/1 (0.00%)    
Gastrointestinal disorders         
Inguinal hernia * 1  1/59 (1.69%)  1 0/47 (0.00%)  0 0/100 (0.00%)  0 0/1 (0.00%)  0
Vomiting * 1  0/59 (0.00%)  0 1/47 (2.13%)  1 0/100 (0.00%)  0 0/1 (0.00%)  0
Infections and infestations         
Bronchopneumonia * 1  0/59 (0.00%)  0 0/47 (0.00%)  0 1/100 (1.00%)  1 0/1 (0.00%)  0
Gastroenteritis * 1  0/59 (0.00%)  0 0/47 (0.00%)  0 1/100 (1.00%)  1 0/1 (0.00%)  0
Pneumonia * 1  0/59 (0.00%)  0 1/47 (2.13%)  1 0/100 (0.00%)  0 0/1 (0.00%)  0
Injury, poisoning and procedural complications         
Femur fracture * 1  0/59 (0.00%)  0 1/47 (2.13%)  1 0/100 (0.00%)  0 0/1 (0.00%)  0
Respiratory, thoracic and mediastinal disorders         
Atelectasis * 1  0/59 (0.00%)  0 0/47 (0.00%)  0 1/100 (1.00%)  1 0/1 (0.00%)  0
Dyspnoea * 1  0/59 (0.00%)  0 0/47 (0.00%)  0 1/100 (1.00%)  1 0/1 (0.00%)  0
Wheezing * 1  3/59 (5.08%)  3 0/47 (0.00%)  0 1/100 (1.00%)  2 0/1 (0.00%)  0
Skin and subcutaneous tissue disorders         
Dermatitis atopic * 1  1/59 (1.69%)  1 0/47 (0.00%)  0 0/100 (0.00%)  0 0/1 (0.00%)  0
Urticaria * 1  0/59 (0.00%)  0 1/47 (2.13%)  1 0/100 (0.00%)  0 0/1 (0.00%)  0
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA 8.0
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
LCTZ-LCTZ LCTZ-PLC PLC-PLC PLC-LCTZ
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   48/59 (81.36%)      36/47 (76.60%)      71/100 (71.00%)      1/1 (100.00%)    
Eye disorders         
Conjunctivitis * 1  3/59 (5.08%)  4 5/47 (10.64%)  8 5/100 (5.00%)  7 0/1 (0.00%)  0
Gastrointestinal disorders         
Diarrhoea * 1  4/59 (6.78%)  4 3/47 (6.38%)  3 5/100 (5.00%)  5 0/1 (0.00%)  0
Vomiting * 1  5/59 (8.47%)  6 4/47 (8.51%)  6 5/100 (5.00%)  6 0/1 (0.00%)  0
General disorders         
Pyrexia * 1  10/59 (16.95%)  13 7/47 (14.89%)  9 13/100 (13.00%)  20 0/1 (0.00%)  0
Infections and infestations         
Acute tonsillitis * 1  0/59 (0.00%)  0 4/47 (8.51%)  5 2/100 (2.00%)  2 1/1 (100.00%)  1
Bronchitis * 1  9/59 (15.25%)  11 6/47 (12.77%)  10 16/100 (16.00%)  26 0/1 (0.00%)  0
Bronchitis acute * 1  3/59 (5.08%)  5 3/47 (6.38%)  4 5/100 (5.00%)  6 0/1 (0.00%)  0
Ear infection * 1  5/59 (8.47%)  7 2/47 (4.26%)  3 6/100 (6.00%)  10 0/1 (0.00%)  0
Gastroenteritis * 1  8/59 (13.56%)  10 2/47 (4.26%)  2 9/100 (9.00%)  11 0/1 (0.00%)  0
Laryngitis * 1  4/59 (6.78%)  5 3/47 (6.38%)  4 2/100 (2.00%)  2 0/1 (0.00%)  0
Nasopharyngitis * 1  10/59 (16.95%)  15 11/47 (23.40%)  21 17/100 (17.00%)  46 0/1 (0.00%)  0
Otitis media * 1  1/59 (1.69%)  1 4/47 (8.51%)  5 9/100 (9.00%)  15 0/1 (0.00%)  0
Otitis media acute * 1  1/59 (1.69%)  1 1/47 (2.13%)  2 5/100 (5.00%)  6 0/1 (0.00%)  0
Pharyngitis * 1  8/59 (13.56%)  10 10/47 (21.28%)  27 12/100 (12.00%)  19 0/1 (0.00%)  0
Rhinitis * 1  15/59 (25.42%)  32 3/47 (6.38%)  4 12/100 (12.00%)  32 1/1 (100.00%)  1
Scarlet fever * 1  3/59 (5.08%)  4 1/47 (2.13%)  1 1/100 (1.00%)  1 0/1 (0.00%)  0
Tonsillitis * 1  2/59 (3.39%)  3 1/47 (2.13%)  2 10/100 (10.00%)  11 0/1 (0.00%)  0
Upper respiratory tract infection * 1  17/59 (28.81%)  46 10/47 (21.28%)  30 20/100 (20.00%)  48 0/1 (0.00%)  0
Varicella * 1  3/59 (5.08%)  3 2/47 (4.26%)  2 7/100 (7.00%)  7 0/1 (0.00%)  0
Viral infection * 1  1/59 (1.69%)  1 5/47 (10.64%)  6 4/100 (4.00%)  6 0/1 (0.00%)  0
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA 8.0
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.
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.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: UCB Clinical Trial Call Center
Organization: UCB Pharma
Phone: +1 877 822 9493
Layout table for additonal information
Responsible Party: UCB Pharma
ClinicalTrials.gov Identifier: NCT00160563    
Other Study ID Numbers: A00384
First Submitted: September 8, 2005
First Posted: September 12, 2005
Results First Submitted: June 17, 2009
Results First Posted: August 4, 2009
Last Update Posted: March 3, 2015