Public Assessment Report for paediatric studies submitted in ...

Peak expiratory flow
Mean Baseline AM and PM PEF were slightly lower in the VENTOLIN HFA 90mcg group
than in the other two treatment groups. Small mean increases in AM and PM PEF was noted in both of the
VENTOLIN HFA treated groups over 4 weeks of treatment, however these increases were slightly less in
the VENTOLIN HFA 90mcg group. At baseline and endpoint the mean AM and PM PEF were
comparable in VENTOLIN HFA treated groups
Safety results
Adverse events
The overall incidence of adverse events occurring both pre-treatment and during treatment were
similar among the treatment groups and the adverse events that occurred most frequently in this study
were as expected in a population of children 243% of subjects and greater than placebo. A total of 33 subjects (43%)
reported at least one AE during treatment: 11 subjects (42%) in the placebo group, 9 subjects (35%) in the
VENTOLIN HFA 90mcg group, and 13 subjects (52%) in the VENTOLIN HFA 180mcg group.
System organ classes with the highest incidence of AEs were infections and infestations (2
subjects in the placebo group, 3 subjects in the VENTOLIN HFA 90mcg group, and 5 subjects in the
VENTOLIN HFA 180mcg group) and investigations (e.g., ECG and laboratory findings-no subjects in
the placebo group, 3 subjects in the VENTOLIN HFA 90mcg group, and 4 subjects in the VENTOLIN
HFA 180mcg group).
A total of 3 subjects had one AE each considered by the investigator to be potentially drug
related (2 subjects in the VENTOLIN HFA 90mcg group and 1 subject in the VENTOLIN HFA 180mcg
group). In the VENTOLIN HFA 90mcg group, drug-related AEs were “Blood alkaline phosphatase
increase” and “Electrocardiogram QT corrected interval prolonged.” In the VENTOLIN HFA 180 mcg
group, the drug-related AE was psychomotor hyperactivity. These AEs did not lead to subject withdrawal
from the study
Signs and symptoms of adrenergic stimulation
At all on-treatment assessments, most subjects (91-100%) had no tremor present. No moderate or
severe tremor was reported at any time during the study. At the post treatment assessment on Day 1, mild
tremor was reported for two subjects (one each) in the VENTOLIN HFA 90 and 180mcgs group.
However the subject in the VENTOLIN HFA 180mcg did not have any further episodes of tremor after
week 1, during the study. Mild tremor was reported for ≤2 subjects at each subsequent treatment
assessment. At Week 4, mild tremor was reported in 1-2 subjects in the VENTOLIN HFA treatment
groups and in no subjects in the placebo treated group.
FSII(R) questionnaire
Functional Status II (R) was assessed by the parent/guardian-for the study site administered
FSII(R) questionnaire for each subjects. Mean Baseline scores ranged from 82.6 to 85.6 and indicated a
high pre-treatment functioning. There was improvement in scores over the treatment period in all
treatment groups (adjusted mean Endpoint scores ranged from 88.1 to 92.0). However no significant
differences were observed between the VENTOLIN HFA treatment groups and the placebo treatment
group
Clinical laboratory assessment
No AEs of hypokalemia were reported
Blood glucose values remained fairly consistent across the treatment groups over the course of
the study.
Hyperglycemia was reported for one subject in the placebo group.
ECG monitoring
Most subjects had normal cardiovascular assessments and results were comparable in the
treatment groups. There were no clinically relevant differences in the mean change from baseline in the
QT interval between treatment groups.
Salbutamol Final Public Assessment Report
RO/W/0001/pdWS/001
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