FOLLOW-UP OF SAFETY AND EFFECTIVENESS OF FLUTICASONEPROPIONATE IN CHILDREN AND ADOLESCENTS WITH ASTHMA
Abstract
Background. For pediatric patients who suffer from
persistent asthma, inhalation corticosteroid therapy is of an
increasing importance. It has been known that inhalation therapy
lowers drug related risks in this population. The present
study was aimed to show that protective therapy using inhalation
corticosteroid fluticasonepropionate (ICS-FP) improves
the health status of children with asthma and that low doses of
ICS-FP have no clinically significant side effects, even in a long
term use.
Methods. Sixty-five children with predominantly moderate
asthma treated with protective anti-inflammatory drug ICSFP
for more than six months were monitored in an ambulatory
setting. The study included children and adolescents aged
5–18 years. The efficacy of the protective treatment with ICSFP
was investigated by measurements of eosinophilic cationic
protein (ECP) in serum and spirometric parameters at the
beginning and after six months of the treatment. The safety of
protective treatment was assessed with measurements of body
mass and height of the children and morning serum cortisol
levels.
Results. During the protective treatment the number of asthma
exacerbation diminished. The triggers of nonallergic exacerbations
were physical activity, changes of weather and viral
inflammations and the triggers of allergic asthma exacerbations
were allergens (hous-dust mite, pollens and animal
dander) and infections.
ECP values similarly showed a statistically significant decrease
from 43.1 ± 27.8 nmol/L at the beginning to 20.3 ± 13.0
nmol/L after six months. Values of spirometric parameters,
expressed as percentage of normal values for the population
under study, exhibited 7–14% improvement in the six months
observation period. All their changes were statistically significant,
e.g. in FEV1 from 82.8 ± 12.4% to 96.3 ± 16.0%.
Despite regular and appropriate treatment with ICS-FP, no
decrease in morning serum cortisol levels exceeding normal
values were observed. From 417.1 ± 138.4nmol/L at the beginning
of the study, cortisol levels fell to 357.1 ± 12.3 nmol/L,
a statistically significant difference. However, these changes
were small relative to the normal range of cortisol diurnal
variability.
Measurements of body mass and height upon regular six
months periods did not show significantly lower values from
those in healthy populations of same ages. On the contrary,
the observed sample even had a significantly higher body
height (relative body height increase of 1.9%) and body mass
(relative body mass increase of 7.3%) when compared to
healthy population.
Conclusions. Present study indicates that ICS-FP protective antiinflammatory
treatment of children and adolescents is safe
and effective related to the age of the patient and severity of
exacerbations.
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