Trial Outcomes & Findings for 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) (NCT NCT00160563)
NCT ID: NCT00160563
Last Updated: 2015-03-03
Results Overview
Recruitment status
TERMINATED
Study phase
PHASE3
Target enrollment
207 participants
Primary outcome timeframe
36 months (from the randomization visit to the preceding A00309 - NCT00152464 trial onwards.)
Results posted on
2015-03-03
Participant Flow
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.
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.
Participant milestones
| Measure |
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)
|
|---|---|---|---|
|
Overall Study
STARTED
|
59
|
47
|
101
|
|
Overall Study
COMPLETED
|
8
|
2
|
11
|
|
Overall Study
NOT COMPLETED
|
51
|
45
|
90
|
Reasons for withdrawal
| Measure |
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)
|
|---|---|---|---|
|
Overall Study
Adverse Event
|
1
|
1
|
1
|
|
Overall Study
Lost to Follow-up
|
1
|
1
|
2
|
|
Overall Study
Protocol Violation
|
0
|
0
|
3
|
|
Overall Study
Withdrawal by Subject
|
1
|
2
|
3
|
|
Overall Study
Other (listed in the study report)
|
48
|
40
|
81
|
|
Overall Study
Missing reason
|
0
|
1
|
0
|
Baseline Characteristics
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)
Baseline characteristics by cohort
| Measure |
LCTZ-LCTZ
n=59 Participants
Levocetirizine after having been randomized to Levocetirizine in the preceding A00309 trial (LCTZ-LCTZ)
|
LCTZ-PLC
n=47 Participants
Placebo after having been randomized to Levocetirizine in the preceding A00309 trial (LCTZ - PLC)
|
PLC-PLC
n=101 Participants
Placebo after having been randomized to Placebo in the preceding A00309 trial (PLC-PLC)
|
Total
n=207 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
19.6 months
STANDARD_DEVIATION 3.58 • n=5 Participants
|
18.9 months
STANDARD_DEVIATION 4.08 • n=7 Participants
|
19.2 months
STANDARD_DEVIATION 4.10 • n=5 Participants
|
19.2 months
STANDARD_DEVIATION 3.94 • n=4 Participants
|
|
Sex: Female, Male
Female
|
23 Participants
n=5 Participants
|
25 Participants
n=7 Participants
|
38 Participants
n=5 Participants
|
86 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
36 Participants
n=5 Participants
|
22 Participants
n=7 Participants
|
63 Participants
n=5 Participants
|
121 Participants
n=4 Participants
|
|
Region of Enrollment
France
|
2 participants
n=5 Participants
|
3 participants
n=7 Participants
|
9 participants
n=5 Participants
|
14 participants
n=4 Participants
|
|
Region of Enrollment
Czech Republic
|
9 participants
n=5 Participants
|
8 participants
n=7 Participants
|
17 participants
n=5 Participants
|
34 participants
n=4 Participants
|
|
Region of Enrollment
Poland
|
11 participants
n=5 Participants
|
9 participants
n=7 Participants
|
18 participants
n=5 Participants
|
38 participants
n=4 Participants
|
|
Region of Enrollment
Spain
|
0 participants
n=5 Participants
|
1 participants
n=7 Participants
|
2 participants
n=5 Participants
|
3 participants
n=4 Participants
|
|
Region of Enrollment
Belgium
|
3 participants
n=5 Participants
|
0 participants
n=7 Participants
|
1 participants
n=5 Participants
|
4 participants
n=4 Participants
|
|
Region of Enrollment
Australia
|
2 participants
n=5 Participants
|
3 participants
n=7 Participants
|
2 participants
n=5 Participants
|
7 participants
n=4 Participants
|
|
Region of Enrollment
South Africa
|
15 participants
n=5 Participants
|
10 participants
n=7 Participants
|
22 participants
n=5 Participants
|
47 participants
n=4 Participants
|
|
Region of Enrollment
Germany
|
9 participants
n=5 Participants
|
4 participants
n=7 Participants
|
13 participants
n=5 Participants
|
26 participants
n=4 Participants
|
|
Region of Enrollment
Italy
|
6 participants
n=5 Participants
|
7 participants
n=7 Participants
|
13 participants
n=5 Participants
|
26 participants
n=4 Participants
|
|
Region of Enrollment
United Kingdom
|
2 participants
n=5 Participants
|
2 participants
n=7 Participants
|
4 participants
n=5 Participants
|
8 participants
n=4 Participants
|
PRIMARY outcome
Timeframe: 36 months (from the randomization visit to the preceding A00309 - NCT00152464 trial onwards.)Population: Analysis was not performed due to premature discontinuation of the study.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 18 months (from the end of the preceding A00309 - NCT00152464 trial onwards.)Population: Analysis was not performed due to premature discontinuation of the study.
Outcome measures
Outcome data not reported
Adverse Events
LCTZ-LCTZ
Serious events: 5 serious events
Other events: 48 other events
Deaths: 0 deaths
LCTZ-PLC
Serious events: 3 serious events
Other events: 36 other events
Deaths: 0 deaths
PLC-PLC
Serious events: 3 serious events
Other events: 71 other events
Deaths: 0 deaths
PLC-LCTZ
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
LCTZ-LCTZ
n=59 participants at risk
Levocetirizine after having been randomized to Levocetirizine in the preceding A00309 trial (LCTZ-LCTZ)
|
LCTZ-PLC
n=47 participants at risk
Placebo after having been randomized to Levocetirizine in the preceding A00309 trial (LCTZ - PLC)
|
PLC-PLC
n=100 participants at risk
Placebo after having been randomized to Placebo in the preceding A00309 trial (PLC-PLC)
|
PLC-LCTZ
n=1 participants at risk
Levocetirizine after having been randomized to Placebo in the preceding A00309 trial (PLC-LCTZ) erroneously (Patient 016/1709)
|
|---|---|---|---|---|
|
Gastrointestinal disorders
Inguinal hernia
|
1.7%
1/59 • Number of events 1
|
0.00%
0/47
|
0.00%
0/100
|
0.00%
0/1
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/59
|
2.1%
1/47 • Number of events 1
|
0.00%
0/100
|
0.00%
0/1
|
|
Infections and infestations
Bronchopneumonia
|
0.00%
0/59
|
0.00%
0/47
|
1.0%
1/100 • Number of events 1
|
0.00%
0/1
|
|
Infections and infestations
Gastroenteritis
|
0.00%
0/59
|
0.00%
0/47
|
1.0%
1/100 • Number of events 1
|
0.00%
0/1
|
|
Infections and infestations
Pneumonia
|
0.00%
0/59
|
2.1%
1/47 • Number of events 1
|
0.00%
0/100
|
0.00%
0/1
|
|
Injury, poisoning and procedural complications
Femur fracture
|
0.00%
0/59
|
2.1%
1/47 • Number of events 1
|
0.00%
0/100
|
0.00%
0/1
|
|
Respiratory, thoracic and mediastinal disorders
Atelectasis
|
0.00%
0/59
|
0.00%
0/47
|
1.0%
1/100 • Number of events 1
|
0.00%
0/1
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.00%
0/59
|
0.00%
0/47
|
1.0%
1/100 • Number of events 1
|
0.00%
0/1
|
|
Respiratory, thoracic and mediastinal disorders
Wheezing
|
5.1%
3/59 • Number of events 3
|
0.00%
0/47
|
1.0%
1/100 • Number of events 2
|
0.00%
0/1
|
|
Skin and subcutaneous tissue disorders
Dermatitis atopic
|
1.7%
1/59 • Number of events 1
|
0.00%
0/47
|
0.00%
0/100
|
0.00%
0/1
|
|
Skin and subcutaneous tissue disorders
Urticaria
|
0.00%
0/59
|
2.1%
1/47 • Number of events 1
|
0.00%
0/100
|
0.00%
0/1
|
Other adverse events
| Measure |
LCTZ-LCTZ
n=59 participants at risk
Levocetirizine after having been randomized to Levocetirizine in the preceding A00309 trial (LCTZ-LCTZ)
|
LCTZ-PLC
n=47 participants at risk
Placebo after having been randomized to Levocetirizine in the preceding A00309 trial (LCTZ - PLC)
|
PLC-PLC
n=100 participants at risk
Placebo after having been randomized to Placebo in the preceding A00309 trial (PLC-PLC)
|
PLC-LCTZ
n=1 participants at risk
Levocetirizine after having been randomized to Placebo in the preceding A00309 trial (PLC-LCTZ) erroneously (Patient 016/1709)
|
|---|---|---|---|---|
|
Eye disorders
Conjunctivitis
|
5.1%
3/59 • Number of events 4
|
10.6%
5/47 • Number of events 8
|
5.0%
5/100 • Number of events 7
|
0.00%
0/1
|
|
Gastrointestinal disorders
Diarrhoea
|
6.8%
4/59 • Number of events 4
|
6.4%
3/47 • Number of events 3
|
5.0%
5/100 • Number of events 5
|
0.00%
0/1
|
|
Gastrointestinal disorders
Vomiting
|
8.5%
5/59 • Number of events 6
|
8.5%
4/47 • Number of events 6
|
5.0%
5/100 • Number of events 6
|
0.00%
0/1
|
|
General disorders
Pyrexia
|
16.9%
10/59 • Number of events 13
|
14.9%
7/47 • Number of events 9
|
13.0%
13/100 • Number of events 20
|
0.00%
0/1
|
|
Infections and infestations
Acute tonsillitis
|
0.00%
0/59
|
8.5%
4/47 • Number of events 5
|
2.0%
2/100 • Number of events 2
|
100.0%
1/1 • Number of events 1
|
|
Infections and infestations
Bronchitis
|
15.3%
9/59 • Number of events 11
|
12.8%
6/47 • Number of events 10
|
16.0%
16/100 • Number of events 26
|
0.00%
0/1
|
|
Infections and infestations
Bronchitis acute
|
5.1%
3/59 • Number of events 5
|
6.4%
3/47 • Number of events 4
|
5.0%
5/100 • Number of events 6
|
0.00%
0/1
|
|
Infections and infestations
Ear infection
|
8.5%
5/59 • Number of events 7
|
4.3%
2/47 • Number of events 3
|
6.0%
6/100 • Number of events 10
|
0.00%
0/1
|
|
Infections and infestations
Gastroenteritis
|
13.6%
8/59 • Number of events 10
|
4.3%
2/47 • Number of events 2
|
9.0%
9/100 • Number of events 11
|
0.00%
0/1
|
|
Infections and infestations
Laryngitis
|
6.8%
4/59 • Number of events 5
|
6.4%
3/47 • Number of events 4
|
2.0%
2/100 • Number of events 2
|
0.00%
0/1
|
|
Infections and infestations
Nasopharyngitis
|
16.9%
10/59 • Number of events 15
|
23.4%
11/47 • Number of events 21
|
17.0%
17/100 • Number of events 46
|
0.00%
0/1
|
|
Infections and infestations
Otitis media
|
1.7%
1/59 • Number of events 1
|
8.5%
4/47 • Number of events 5
|
9.0%
9/100 • Number of events 15
|
0.00%
0/1
|
|
Infections and infestations
Otitis media acute
|
1.7%
1/59 • Number of events 1
|
2.1%
1/47 • Number of events 2
|
5.0%
5/100 • Number of events 6
|
0.00%
0/1
|
|
Infections and infestations
Pharyngitis
|
13.6%
8/59 • Number of events 10
|
21.3%
10/47 • Number of events 27
|
12.0%
12/100 • Number of events 19
|
0.00%
0/1
|
|
Infections and infestations
Rhinitis
|
25.4%
15/59 • Number of events 32
|
6.4%
3/47 • Number of events 4
|
12.0%
12/100 • Number of events 32
|
100.0%
1/1 • Number of events 1
|
|
Infections and infestations
Scarlet fever
|
5.1%
3/59 • Number of events 4
|
2.1%
1/47 • Number of events 1
|
1.0%
1/100 • Number of events 1
|
0.00%
0/1
|
|
Infections and infestations
Tonsillitis
|
3.4%
2/59 • Number of events 3
|
2.1%
1/47 • Number of events 2
|
10.0%
10/100 • Number of events 11
|
0.00%
0/1
|
|
Infections and infestations
Upper respiratory tract infection
|
28.8%
17/59 • Number of events 46
|
21.3%
10/47 • Number of events 30
|
20.0%
20/100 • Number of events 48
|
0.00%
0/1
|
|
Infections and infestations
Varicella
|
5.1%
3/59 • Number of events 3
|
4.3%
2/47 • Number of events 2
|
7.0%
7/100 • Number of events 7
|
0.00%
0/1
|
|
Infections and infestations
Viral infection
|
1.7%
1/59 • Number of events 1
|
10.6%
5/47 • Number of events 6
|
4.0%
4/100 • Number of events 6
|
0.00%
0/1
|
Additional Information
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Phone: +1 877 822 9493
Results disclosure agreements
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