Evidence map›Paper›PMID 27670203›Full record

Trial reportBrazilian journal of otorhinolaryngology

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, Carolina Miranda, Luis Felipe Ensina, Flavio Sano, Roberto Bleul Amazonas, Joyce Macedo da Silva, Dirceu Solé

Registry-linked trialOpen access · goldAbstract readRandomized Controlled Trial
In one paragraph

Trial report in Brazilian journal of otorhinolaryngology. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT06916884 (Confirmatory Study on the Efficacy and Safety of the Fixed-dose Combination of Desloratadine/Betamethasone Versus Desloratadine as Treatment in Patients With Allergic Rhinitis), which is not on this map. Cited by 3 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
3citing papers in PubMed, 1 pooled it
0.4field-weighted citation impact, top 33% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT06916884 phase3completednot on this map

Confirmatory Study on the Efficacy and Safety of the Fixed-dose Combination of Desloratadine/Betamethasone Versus Desloratadine as Treatment in Patients With Allergic Rhinitis

TypeinterventionalSponsorLaboratorios Silanes S.A. de C.V.Ran2024 to 2025Enrolled70ConditionsAllergic RhinitisArmsDesloratadine / Betamethasone in fixed dose, Desloratadine
3 · Its place in the literature

Who cites it

3 citing papers in PubMed, 1 synthesis or guideline pooled it, 11 citations in OpenAlex.

  1. Pooled it
  2. Article
  3. IV Brazilian Consensus on Rhinitis - an update on allergic rhinitis.Brazilian journal of otorhinolaryngology · 2017
    Article
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

7 authors at 3 institutions in 1 country.

Gustavo F WandalsenUniversidade Federal de São Paulo (Unifesp), Escola Paulista de Medicina, (EPM) Departamento de Pediatria, São Paulo, SP, Brazil.
Carolina MirandaUniversidade 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.
Luis Felipe EnsinaUniversidade 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.
Flavio SanoHospital Nipo-Brasileiro, Pediatria, São Paulo, SP, Brazil.
Roberto Bleul AmazonasUniversidade 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.
Joyce Macedo da SilvaGrupo NC Farma, Pesquisa Clínica e Farmacovigilância, São Paulo, SP, Brazil.
Dirceu SoléUniversidade Federal de São Paulo (Unifesp), Escola Paulista de Medicina, (EPM) Departamento de Pediatria, São Paulo, SP, Brazil. Electronic address: dirceu.sole@unifesp.br.
Universidade Federal de São Paulo · BRFundação Getulio Vargas · BRHospital IPO · BR

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

introductionA combination of antihistamines and oral corticosteroids is often used to treat acute symptoms of allergic rhinitis.

objectiveTo 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.

methodsChildren 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.

resultsThe 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).

conclusionThe 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.

Indexed as

BetamethasoneChildChild, PreschoolDouble-Blind MethodDrug CombinationsFemaleGlucocorticoidsHistamine H1 Antagonists, Non-SedatingHumansLoratadineMalePeak Expiratory Flow RatePrednisoloneReproducibility of ResultsRhinitis, AllergicSeverity of Illness IndexBetamethasonedesloratadineDrug CombinationsGlucocorticoidsHistamine H1 Antagonists, Non-SedatingLoratadinePrednisoloneAllergic rhinitisBetametasonaBetamethasoneDesloratadinaDesloratadineDexchlorpheniramineDexclorfeniraminaPrednisolonaPrednisoloneRinite alérgica

Identifiers

PMID27670203
PMCPMC9449020
OpenAlexW2519958806

What OpenQuestion holds

Textmetadata
LicenceCC BY
Read underepoch 390

Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.