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Randomized Controlled Trial
. 2017 Nov-Dec;83(6):633-639.
doi: 10.1016/j.bjorl.2016.08.009. Epub 2016 Sep 13.

Association between desloratadine and prednisolone in the treatment of children with acute symptoms of allergic rhinitis: a double-blind, randomized and controlled clinical trial

Gustavo F Wandalsen  1 , Carolina Miranda  2 , Luis Felipe Ensina  3 , Flavio Sano  4 , Roberto Bleul Amazonas  5 , Joyce Macedo da Silva  6 , Dirceu Solé  7
Affiliations
Randomized Controlled Trial

Association between desloratadine and prednisolone in the treatment of children with acute symptoms of allergic rhinitis: a double-blind, randomized and controlled clinical trial

Gustavo F Wandalsen et al. Braz J Otorhinolaryngol. 2017 Nov-Dec.

Abstract
in English, Portuguese

Introduction: 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).

Conclusion: 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.

Introdução: A associação entre anti-histamínicos e corticosteroides orais é frequentemente empregada no tratamento de sintomas agudos de Rinite Alérgica.

Objetivo: Avaliar a segurança e eficácia da associação desloratadina + prednisolona no tratamento de sintomas agudos de crianças (2–12 anos) com rinite alérgica e compará-la à de dexclorfeniramina + betametasona.

Método: Crianças com rinite alérgica persistente moderada/grave e sintomáticas (escore de sintomas nasais [0–12] ≥ 6) foram alocadas de modo duplo-cego e randômico para receberem dexclorfeniramina + betametasona (n = 105; três doses diárias) ou desloratadina + prednisolona (n = 105; dose única seguida por duas de placebo) por 7 dias. Ao início e final da avaliação foram obtidos: escore de sintomas nasais, escore de sintomas extra-nasais, pico de fluxo inspiratório nasal, bioquímica sanguínea e eletrocardiograma. Do total, 96 crianças do grupo dexclorfeniramina + betametasona e 98 do grupo desloratadina + prednisolona concluíram o protocolo.

Resultados: Os dois grupos foram iguais com relação ao escore de sintomas nasais, escore de sintomas nasais extra-nasais e pico de fluxo inspiratório nasal iniciais e finais. Observou-se queda de 76,4% e 79,1% nos escores para escore de sintomas nasais, de 86,0% e 79,2% para escore de sintomas extra-nasais, assim como incremento de 25,2% e de 24,3% para o pico de fluxo inspiratório nasal para os grupos desloratadina + prednisolona e dexclorfeniramina + betametasona, respectivamente. Não houve alterações significativas da bioquímica sanguínea. Taquicardia sinusal foi a alteração do eletrocardiograma mais encontrada, mas sem significância clínica. Sonolência foi significantemente mais referida entre os tratados com dexclorfeniramina + betametasona do que entre os desloratadina + prednisolona (8,57% × 17,14%, respectivamente).

Conclusão: A associação desloratadina + prednisolona foi capaz de controlar efetivamente os sintomas agudos de rinite em crianças, melhorando sintomas e a função nasal. Na comparação com a associação dexclorfeniramina + betametasona, demonstrou ação clínica semelhante, mas com menor incidência de eventos adversos e maior comodidade posológica.

Keywords: Allergic rhinitis; Betametasona; Betamethasone; Desloratadina; Desloratadine; Dexchlorpheniramine; Dexclorfeniramina; Prednisolona; Prednisolone; Rinite alérgica.

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Figures

Figure 1
Figure 1
Progression of score (average) of nasal and extranasal (Ex) symptoms according to the treatment group: desloratadine + prednisolone (DP and DPEx, respectively) or dexchlorpheniramine + betamethasone (DB and DBEx, respectively) according to different days.
See this image and copyright information in PMC

References

    1. Bousquet J., Khaltaev N., Cruz A., Denburg J., Fokkens W., Togias A., et al. Allergic Rhinitis and its Impact on Asthma (ARIA) 2008 update. Allergy. 2008;63(Suppl.):S8–S160. - PubMed
    1. Affrime M., Banfield C., Gupta S., Cohen A., Boutros T., Thonoor M., et al. A pharmacokinetic profile of desloratadine in healthy adults including elderly subjects. Clin Pharmacokinet. 2002;41:21–28. - PubMed
    1. Banfield C., Herron J., Keung A., Padhi D., Affrime M. Desloratadine has no electrocardiographic or pharmacodynamic interactions with ketoconazole. Clin Pharmacokinet. 2002;41:37–44. - PubMed
    1. Kreutner W., Hey J.A., Anthes J., Barnett A., Young S., Tozzi S. Preclinical pharmacology of desloratadine, a selective and nonsedating histamine H1 receptor antagonist: 1st communication: receptor selectivity, antihistamine activity, and antiallergenic effects. Arzneimittelforschung. 2000;50:345–352. - PubMed
    1. Lippert U., Kruger-Krasagakes S., Moller A., Kiessling U., Czametzki B.M. Pharmacological modulation of IL-6 and IL-8 secretion by the H1-antagonist descarboethoxy-loratadine and dexamethasone by human mast and basophilic cell lines. Exp Dermatol. 1995;4:272–276. - PubMed

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