Efficacy and safety of the combination fluticasone propionate plus salmeterol in asthmatic preschoolers: An observational study

ABSTRACT

Background: Inhaled Corticosteroids (ICS) are the cornerstone of asthma management in pediatric patients. However, in some cases, asthma is not adequately controlled on ICS alone. Long-acting beta₂-agonists (LABA) are one of the available additional therapies but their use has rarely been studied among children younger than 5 years. Objective: The aim of this observational study was to evaluate the efficacy and safety of the combination of fluticasone propionate and salmeterol (FP/SA) in asthmatic children younger than 5 years of age. Methods: A retrospective study of 796 children under the age of 5 years (2.87 ± 1.22 years, 64.2% males), who were treated with FP/SA was conducted. Hospitalization rates, frequency of wheezing, exercise induced asthma, nocturnal wheeze and drug-related side-effects were recorded through children's medical records. Results: The children had previously received short-acting β₂-agonists (73%), ICS (17%), montelukast (1%), and ICS with montelukast (2%). Mean duration of therapy with FP/SA was 12.45 ± 9.14 months. After adjusting for age, gender, and duration of treatment, a 89% reduction was recorded in annual hospitalization rates (from 27.13% before treatment to 3.01% after FP/SA therapy, p < 0.001), a 71% reduction in incidence of exercise-induced asthma (36.8% vs. after 10.6%, p < 0.001), a 81% reduction in nocturnal asthma (33.7% vs. after: 6.4%, p < 0.001), as well as in frequency of wheezing (p < 0.01),. No previous treatment carry-on effect was observed. No major drug-related side-effects occurred in the study group. Conclusions: Combination therapy (FP/SA) is well-tolerated and highly effective in asthmatic children under the age of 5 years.

KEYWORDS:

• Asthma
• children
• inhaled corticosteroids with long-acting beta₂-agonists

Disclosure of potential conflicts of interest

No potential conflicts of interest were disclosed.

Ethics approval

Hippokration Hospital Ethics Committee approval.

Contributors

EH, DBP and JT had full access to all of the data in the study and take responsibility for the integrity of the data and the accuracy of the data analysis. EH, FK and JT contributed substantially to the study design, data analysis and interpretation. DBP and EH performed the statistical analysis. EK, DP, DT and PA collected all retrospective data of the study. All the authors contributed to the writing of the manuscript. EH, EK, DBP and JT reviewed and edited the manuscript. EH and JT are guarantors.

Additional information

Funding

None