Public Assessment Report for paediatric studies submitted in ...

subjects in the VENTOLIN HFA 180mcg group), and sinus arrhythmia (1 subject in the VENTOLIN
90mcg group only). Other adverse events were reported in one or less subjects per treatment group.
Symptoms of adrenergic stimulation
At all on-treatment assessments, all subjects had no tremor present.
The mean change from baseline in the heart rates for the week 4 pre and post dose were
consistent in terms of a drop in all three treatment groups (i.e. range of -1.6 to - 5.4 for the week 4 predose
and -2.9 to 3.0 for the week 4 post dose group) except for the post-dose VENTOLIN 180mcg group
where the heart rate increased by 3 beats/minute.
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 scores were similar across the treatment groups at Baseline
and at Endpoint except for the sleep well and unusually irritable scores at baseline that were slightly lower
in the placebo 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.
No AEs of hyperglycemia were reported. Six subjects, (2 in the placebo group and 3 and 1
subject in the VENTOLIN 90mcg and VENTOLIN 180mcg groups respectively) had laboratory errors at
the study termination visit either due to hemolysis, failed blood draw attempts and/or parent refusal to
blood draw
ECG monitoring
At Week 4, mean changes from baseline in heart rate, and QT interval were small. Mean
changes from baseline in heart rates for the subjects in the VENTOLIN HFA 90 mcg group were slightly
higher (-5.4 to -2.9 bpm) when compared to VENTOLIN HFA 180mcg (-1.6 to 3.0 bpm) or placebo (-4.5
to -2.0 bpm). No subject had a QT or QTc (Fridericia’s formula) interval >460msec.
Vital sings
Mean values for systolic and diastolic blood pressure at Week 4 were comparable to those
observed at baseline except for systolic pressure in the VENTOLIN 90 mcg group which was slightly
higher (5.5mmHg) at Week 4. Mean changes from baseline were very small, ranging from 0.4 to
5.5mmHg for systolic blood pressure and -0.9 to 3.4mmHg for diastolic blood pressure.
Mean values for heart rate, body temperature, and respiratory rate at Week 4 were also
comparable to those observed at baseline.
Physical examinations
At the end of the study, there was a higher incidence of unfavorable changes in the VENTOLIN
HFA 180 mcg treatment group (7 subjects) compared to the VENTOLIN HFA 90mcg (2 subjects) and
placebo (3 subjects) treatment group. These changes were primarily ENT (ear, nose and throat), 5 subjects
in the VENTOLIN HFA 180 mcg group vs. 2 and 1 subject in the placebo and VENTOLIN HFA 90mcg
groups respectively. A slightly higher incidence of ENT, hair and skin, and respiratory changes were
noted in the placebo and VENTOLIN HFA 180 mcg treatment groups (2 and 5 subjects respectively)
compared to the placebo group (1 and 2 subjects, respectively) and the VENTOLIN 90mcg group (0
subjects in each body system). An unfavourable change in the urogenital body system was noted in the
VENTOLIN HFA 90 mcg group (1 subject) only.
Assessor's comment:
The results of the primary, secondary and other efficacy parameters showed similar improvements from
baseline in all treatment groups over 4 weeks of treatment.
Salbutamol Final Public Assessment Report
RO/W/0001/pdWS/001
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