PMID- 29958011 OWN - NLM STAT- MEDLINE DCOM- 20200507 LR - 20200507 IS - 1532-4303 (Electronic) IS - 0277-0903 (Linking) VI - 56 IP - 6 DP - 2019 Jun TI - Efficacy and safety of the combination fluticasone propionate plus salmeterol in asthmatic preschoolers: An observational study. PG - 573-580 LID - 10.1080/02770903.2018.1474923 [doi] AB - 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 beta(2)-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 beta(2)-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. FAU - Hatziagorou, Elpis AU - Hatziagorou E AD - a Aristotle University of Thessaloniki , Greece, Paediatric Pulmonology Unit, Hippokration Hospital , Thessaloniki , Greece. FAU - Kouroukli, Eleana AU - Kouroukli E AD - a Aristotle University of Thessaloniki , Greece, Paediatric Pulmonology Unit, Hippokration Hospital , Thessaloniki , Greece. FAU - Galogavrou, Maria AU - Galogavrou M AD - a Aristotle University of Thessaloniki , Greece, Paediatric Pulmonology Unit, Hippokration Hospital , Thessaloniki , Greece. FAU - Papanikolaou, Dafni AU - Papanikolaou D AD - a Aristotle University of Thessaloniki , Greece, Paediatric Pulmonology Unit, Hippokration Hospital , Thessaloniki , Greece. FAU - Terzi, Dr Despoina AU - Terzi DD AD - a Aristotle University of Thessaloniki , Greece, Paediatric Pulmonology Unit, Hippokration Hospital , Thessaloniki , Greece. FAU - Anagnostopoulou, Pinelopi AU - Anagnostopoulou P AD - a Aristotle University of Thessaloniki , Greece, Paediatric Pulmonology Unit, Hippokration Hospital , Thessaloniki , Greece. FAU - Kirvassilis, Fotios AU - Kirvassilis F AD - a Aristotle University of Thessaloniki , Greece, Paediatric Pulmonology Unit, Hippokration Hospital , Thessaloniki , Greece. FAU - Panagiotakos, Demosthenes B AU - Panagiotakos DB AUID- ORCID: 0000-0001-8583-153X AD - b Harokopio University, School of Health Science and Education , Athens , Greece. FAU - Tsanakas, John AU - Tsanakas J AD - a Aristotle University of Thessaloniki , Greece, Paediatric Pulmonology Unit, Hippokration Hospital , Thessaloniki , Greece. LA - eng PT - Journal Article PT - Observational Study DEP - 20180629 PL - England TA - J Asthma JT - The Journal of asthma : official journal of the Association for the Care of Asthma JID - 8106454 RN - 0 (Bronchodilator Agents) RN - 0 (Fluticasone-Salmeterol Drug Combination) SB - IM MH - Asthma/*drug therapy MH - Bronchodilator Agents/adverse effects/*therapeutic use MH - Child, Preschool MH - Female MH - Fluticasone-Salmeterol Drug Combination/adverse effects/*therapeutic use MH - Humans MH - Infant MH - Male MH - Retrospective Studies MH - Treatment Outcome OTO - NOTNLM OT - Asthma OT - children OT - inhaled corticosteroids with long-acting beta-agonists EDAT- 2018/06/30 06:00 MHDA- 2020/05/08 06:00 CRDT- 2018/06/30 06:00 PHST- 2018/06/30 06:00 [pubmed] PHST- 2020/05/08 06:00 [medline] PHST- 2018/06/30 06:00 [entrez] AID - 10.1080/02770903.2018.1474923 [doi] PST - ppublish SO - J Asthma. 2019 Jun;56(6):573-580. doi: 10.1080/02770903.2018.1474923. Epub 2018 Jun 29.