FOLLOW-UP OF SAFETY AND EFFECTIVENESS OF FLUTICASONEPROPIONATE IN CHILDREN AND ADOLESCENTS WITH ASTHMA
|Author:||Maja Skerbinjek Kavalar; Aleksander Brunčko; Stanislav Primožič; Mitja Kos; Dalila Lampe Ivanovska; Ervin Strbad|
|Source:||Directory of Open Access Journals: DOAJ Articles|
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.