Asthma
Conditions
Keywords
Pediatry, EPAAC, atopic Children, prevention of asthma, Levocetirizine, Xyzal
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.
Interventions
DRUGLEVOCETIRIZINE
5mg/mL oral drops, 0.125 mg/kg body weight, bid for 18 months
OTHERPlacebo
Oral drops, bid for 18 months
Sponsors
UCB Pharma
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
30 Months to 42 Months
Healthy volunteers
No
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
Exclusion criteria
* None
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Time to Onset of Asthma | 36 months (from the randomization visit to the preceding A00309 - NCT00152464 trial onwards.) |
Secondary
| Measure | Time frame |
|---|---|
| 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.) |
Countries
Australia, Belgium, Czechia, France, Germany, Italy, Poland, South Africa, Spain, United Kingdom
Participant flow
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.
Participants by arm
| Arm | Count |
|---|---|
| LCTZ-LCTZ Levocetirizine after having been randomized to Levocetirizine in the preceding A00309 trial (LCTZ-LCTZ) | 59 |
| LCTZ-PLC Placebo after having been randomized to Levocetirizine in the preceding A00309 trial (LCTZ - PLC) | 47 |
| PLC-PLC Placebo after having been randomized to Placebo in the preceding A00309 trial (PLC-PLC) | 101 |
| Total | 207 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 |
|---|---|---|---|---|
| Overall Study | Adverse Event | 1 | 1 | 1 |
| Overall Study | Lost to Follow-up | 1 | 1 | 2 |
| Overall Study | Missing reason | 0 | 1 | 0 |
| Overall Study | Other (listed in the study report) | 48 | 40 | 81 |
| Overall Study | Protocol Violation | 0 | 0 | 3 |
| Overall Study | Withdrawal by Subject | 1 | 2 | 3 |
Baseline characteristics
| Characteristic | Total | LCTZ-LCTZ | LCTZ-PLC | PLC-PLC |
|---|---|---|---|---|
| Age, Continuous | 19.2 months STANDARD_DEVIATION 3.94 | 19.6 months STANDARD_DEVIATION 3.58 | 18.9 months STANDARD_DEVIATION 4.08 | 19.2 months STANDARD_DEVIATION 4.1 |
| Region of Enrollment Australia | 7 participants | 2 participants | 3 participants | 2 participants |
| Region of Enrollment Belgium | 4 participants | 3 participants | 0 participants | 1 participants |
| Region of Enrollment Czech Republic | 34 participants | 9 participants | 8 participants | 17 participants |
| Region of Enrollment France | 14 participants | 2 participants | 3 participants | 9 participants |
| Region of Enrollment Germany | 26 participants | 9 participants | 4 participants | 13 participants |
| Region of Enrollment Italy | 26 participants | 6 participants | 7 participants | 13 participants |
| Region of Enrollment Poland | 38 participants | 11 participants | 9 participants | 18 participants |
| Region of Enrollment South Africa | 47 participants | 15 participants | 10 participants | 22 participants |
| Region of Enrollment Spain | 3 participants | 0 participants | 1 participants | 2 participants |
| Region of Enrollment United Kingdom | 8 participants | 2 participants | 2 participants | 4 participants |
| Sex: Female, Male Female | 86 Participants | 23 Participants | 25 Participants | 38 Participants |
| Sex: Female, Male Male | 121 Participants | 36 Participants | 22 Participants | 63 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk |
|---|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — | — / — |
| other Total, other adverse events | 48 / 59 | 36 / 47 | 71 / 100 | 1 / 1 |
| serious Total, serious adverse events | 5 / 59 | 3 / 47 | 3 / 100 | 0 / 1 |
Outcome results
Primary
Time to Onset of Asthma
Time frame: 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.
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.)
Population: Analysis was not performed due to premature discontinuation of the study.