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临床试验/NCT00962299
NCT00962299终止4 期

Effectiveness of Inhaled Corticosteroids in Preschool Children Following Hospital Admission for Acute Dyspnea and Wheeze

Princess Amalia Children's Clinic1 个研究点 分布在 1 个国家目标入组 7 人开始时间: 2010年5月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
4 期
状态
终止
发起方
入组人数
7
试验地点
1
主要终点
Number of unscheduled doctor visits for dyspnea and wheezing

研究概览

简要总结

The aim of the study is to investigate whether inhaled corticosteroids after a first hospital admission for acute dyspnea and wheeze is effective in reducing subsequent episodes of these complaints in children aged 1 to 4 years.

详细描述

Symptoms of dyspnea and wheeze occur frequently in young children with a cumulative incidence of 33% before the age of 3 and up to 50% by the age of 6 years. Most wheezing episodes in preschool children are associated with viral upper respiratory tract infections (episodic viral wheeze). The majority of children with episodic viral wheeze have become asymptomatic by the age of 6 years. About one in three preschool children with recurrent wheeze continue to wheeze after the age of six years, and these children are usually diagnosed with asthma.

Two clinical phenotypes of recurrent wheezing in preschool children can be distinguished. Children with episodic viral wheeze only wheeze with viral upper respiratory tract infections and are symptom free in between episodes. A minority of children wheeze during upper respiratory tract infection and with other trigger factors (such as smoke, fog, exercise) and this is defined as multiple trigger wheeze.

Inhaled corticosteroids (ICS) have been shown to be effective in preschool children with multiple trigger wheeze, but the effect is smaller than that in older children. This justifies a more critical approach towards such therapy, for example by prescribing a trial of ICS for a period of 3 months and evaluating the effect afterwards. Little research has been performed on the effect of ICS in preschool children with episodic viral wheeze. A high dose of ICS (>1600 ug/d) during an acute episode of dyspnea and wheezing has been shown to be effective, but in a number of small clinical trials maintenance treatment with ICS did not have an effect on the number and severity of episodes of viral wheezing. Contradictory results have been published about the effect of ICS in infants and preschool children with Respiratory Syncytial Virus bronchiolitis. Some studies showed a reduction of wheezing episodes after RSV bronchiolitis in children treated with ICS, two other studies did not show any positive effect.

Prescribing ICS in preschool children can result in adverse effects such as a reduced height growth. Because of the lack of evidence of effect of ICS in episodic viral wheeze, guidelines advise a critical approach towards prescribing ICS in episodic viral wheeze.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

入排标准

年龄范围
1 Year 至 4 Years(Child)
性别
All
接受健康志愿者

入选标准

  • Children that are admitted to the paediatric ward of the Isala Klinieken in Zwolle for the first time with acute dyspnea and wheezing
  • Age 1 - 4 years
  • Child and parents must understand the Dutch language well
  • Informed consent

排除标准

  • Previous use of medication different than short-acting β2-agonists before hospital admission
  • Proven RSV bronchiolitis
  • Crackles during auscultation of the lungs (suggestive for RSV bronchiolitis)

研究组 & 干预措施

Beclomethasone

Active Comparator

Inhaled corticosteroids

干预措施: Beclomethasone (Drug)

Placebo

Placebo Comparator

Placebo Comparator

干预措施: Placebo (Drug)

结局指标

主要结局

Number of unscheduled doctor visits for dyspnea and wheezing

时间窗: One and a half, 3, 6 and 9 months after discharge.

次要结局

  • PACQLQ scores and the use of additional asthma medication(One and a half, 3, 6 and 9 months after discharge.)

研究者

发起方
Princess Amalia Children's Clinic
申办方类型
Other
责任方
Principal Investigator
主要研究者

Jolita Bekhof

MD, Pediatrician

Princess Amalia Children's Clinic

研究点 (1)

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