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临床试验/EUCTR2018-001120-18-NL
EUCTR2018-001120-18-NL进行中(未招募)1 期

The protective effect of azelastine/fluticasone propionate (Dymista) on exercise-induced airway obstruction - Protective effect of DYM on EIAO

Stichting Pediatrisch Onderzoek Enschede0 个研究点目标入组 64 人开始时间: 2018年12月11日最近更新:
相关药物

试验速览

阶段
1 期
状态
进行中(未招募)
发起方
入组人数
64

研究概览

简要总结

暂无简介。

研究设计

研究类型
Interventional clinical trial of medicinal product

入排标准

入选标准

  • - Clinical history of allergic rhinitis and EIB (exercise-induced
  • bronchoconstriction)
  • - Age between 12 and 18 years.
  • - Ability to perform spirometry and FOT
  • Are the trial subjects under 18? yes
  • Number of subjects for this age range: 64
  • F.1.2 Adults (18-64 years) no
  • F.1.2.1 Number of subjects for this age range
  • F.1.3 Elderly (>=65 years) no
  • F.1.3.1 Number of subjects for this age range

排除标准

  • - Other pulmonary or cardiac illnesses
  • - Severe EIB i.e. a fall of =40% FEV1 in the first ECT, requiring an acute
  • change in maintenance medication (standard care)
  • - Use of long acting bronchodilator agents 24 hours before testing
  • - Use of short acting bronchodilator agents 8 hours before testing
  • - Hospitalization due to asthma exacerbation in the last 4 weeks
  • - Use of intranasal or systemic corticosteroids in the last 4 weeks prior
  • to the study.
  • - Use of antihistamines, cromoglycates, anticholinergics in two weeks
  • prior the study or during the study.
  • - Other changes in asthma medication during treatment period
  • - Insufficient knowledge of the Dutch language

研究者

发起方
Stichting Pediatrisch Onderzoek Enschede

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