Association between desloratadine and prednisolone in the treatment of children with acute symptoms of allergic rhinitis: a double-blind, randomized and controlled clinical trial.
BACKGROUND
A combination of antihistamines and oral corticosteroids is often used to treat acute symptoms of allergic rhinitis.


OBJECTIVE
To evaluate safety and efficacy of desloratadine plus prednisolone in the treatment of acute symptoms of children (2-12 years) with allergic rhinitis, and to compare it to dexchlorpheniramine plus betamethasone.


METHODS
Children with moderate/severe persistent allergic rhinitis and symptomatic (nasal symptoms score [0-12]≥6) were allocated in a double-blind, randomized fashion to receive dexchlorpheniramine plus betamethasone (n=105; three daily doses) or desloratadine plus prednisolone (n=105; single dose followed by two of placebo) for 7 days. At the beginning and end of the evaluation, the following were obtained: nasal symptoms score, extra nasal symptoms score, peak nasal inspiratory flow, blood biochemistry, and electrocardiogram. Ninety-six children of the dexchlorpheniramine plus betamethasone group and 98 of the desloratadine plus prednisolone group completed the protocol.


RESULTS
The two groups were similar regarding initial and final nasal symptoms scores, extra nasal symptoms scores and peak nasal inspiratory flow. A drop of 76.4% and 79.1% for nasal symptoms score, 86.0% and 79.2% for extra nasal symptoms score, as well as an increase of 25.2% and 24.3% for peak nasal inspiratory flow occurred for those treated with desloratadine plus prednisolone and dexchlorpheniramine plus betamethasone, respectively. There were no significant changes in blood chemistry. Sinus tachycardia was the most frequent electrocardiogram change, but with no clinical significance. Drowsiness was reported significantly more often among those of dexchlorpheniramine plus betamethasone group (17.14%×8.57%, respectively).


CONCLUSIONS
The desloratadine plus prednisolone combination was able to effectively control acute symptoms of rhinitis in children, improving symptoms and nasal function. Compared to the dexchlorpheniramine plus betamethasone combination, it showed similar clinical action, but with a lower incidence of adverse events and higher dosing convenience.
Universidade Federal de São Paulo (Unifesp), Escola Paulista de Medicina, (EPM) Departamento de Pediatria, São Paulo, SP, Brazil.
Gustavo F
GF
Wandalsen
Universidade Federal de São Paulo (Unifesp), Escola Paulista de Medicina, (EPM) Departamento de Ginecologia, São Paulo, SP, Brazil; Fundação de Apoio à Escola Paulista de Medicina (FAP), São Paulo, SP, Brazil.
Carolina
C
Miranda
Universidade Federal de São Paulo (Unifesp), Escola Paulista de Medicina, (EPM) Departamento de Pediatria, São Paulo, SP, Brazil; Universidade de Santo Amaro (Unisa), Clínica Médica, São Paulo, SP, Brazil.
Luis Felipe
LF
Ensina
Hospital Nipo-Brasileiro, Pediatria, São Paulo, SP, Brazil.
Flavio
F
Sano
Universidade Estadual de Campinas (Unicamp), Campinas, SP, Brazil; Fundação Getúlio Vargas, MBA em Marketing, Rio de Janeiro, RJ, Brazil; Grupo NC Farma, São Paulo, SP, Brazil.
Roberto Bleul
RB
Amazonas
Grupo NC Farma, Pesquisa Clínica e Farmacovigilância, São Paulo, SP, Brazil.
Joyce Macedo da
JMD
Silva
Universidade Federal de São Paulo (Unifesp), Escola Paulista de Medicina, (EPM) Departamento de Pediatria, São Paulo, SP, Brazil. Electronic address: dirceu.sole@unifesp.br.
Dirceu
D
Solé
D001623:Betamethasone / Q000008:administration & dosage / Q000009:adverse effects; D002648:Child; D002675:Child, Preschool; D004311:Double-Blind Method; D004338:Drug Combinations; D005260:Female; D005938:Glucocorticoids / Q000008:administration & dosage* / Q000009:adverse effects; D039563:Histamine H1 Antagonists, Non-Sedating / Q000008:administration & dosage* / Q000009:adverse effects; D006801:Humans; D017336:Loratadine / Q000008:administration & dosage / Q000009:adverse effects / Q000031:analogs & derivatives*; D008297:Male; D010366:Peak Expiratory Flow Rate; D011239:Prednisolone / Q000008:administration & dosage* / Q000009:adverse effects; D015203:Reproducibility of Results; D065631:Rhinitis, Allergic / Q000188:drug therapy*; D012720:Severity of Illness Index; D018709:Statistics, Nonparametric; D013997:Time Factors; D016896:Treatment Outcome
D004338:Drug Combinations; D005938:Glucocorticoids; D039563:Histamine H1 Antagonists, Non-Sedating; D017336:Loratadine; D001623:Betamethasone; D011239:Prednisolone; C121345:desloratadine
Allergic rhinitis; Betametasona; Betamethasone; Desloratadina; Desloratadine; Dexchlorpheniramine; Dexclorfeniramina; Prednisolona; Prednisolone; Rinite alérgica
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