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临床试验/ACTRN12619000243112
ACTRN12619000243112终止4 期

Effect of fluticasone propionate for the prevention of perioperative respiratory complications in children undergoing adenotonsillectomy who present with recurrent respiratory symptoms

Telethon Kids Institute0 个研究点目标入组 18 人开始时间: 2019年2月19日最近更新:
适应症

试验速览

阶段
4 期
状态
终止
入组人数
18

研究概览

简要总结

暂无简介。

研究设计

研究类型
Interventional
分配方式
Randomised controlled trial
主要目的
Prevention
盲法
Blinded (masking used)

入排标准

年龄范围
4 Years 至 10 Years(—)
性别
All

入选标准

  • 4 > Age < 10
  • Male/Female
  • Adenotonsilectomy +/- adenoidectomy, grommets, cautery of inferior turbinates, or examination of the ear under general anaesthesia with the use of laryngeal mask airway or endotracheal tubes
  • Respiratory symptoms in the past 12 months including:
  • - shortness of breath
  • - 4 weeks cough
  • - exercise induced respiratory symptoms
  • eNO measurement greater than or equal to 20 ppb

排除标准

  • 4 > Age > 10
  • Cystic Fibrosis, bronchiectasis
  • Significant cardiac disease
  • Preventer asthma medications other than the study intervention in the last 3 months such as:
  • - Inhaled corticosteroids (other than the supplied study intervention e.g. budenoside, beclomethasone dipropionate, mometasone furoate, ciclesonide)
  • - Long-acting beta agonists (other than study intervention) or an extended release short-acting beta-agonist
  • - Leukotriene-receptor agonists (e.g. montelukast), theophylline, cromolyn, or other non-inhaled/oral corticosteroid asthma controller medications
  • Prescription or over the counter medications that would significantly interact with beta-agonists or inhaled corticosteroids
  • Potent Cytochrome P450 3A4 (CYP3A4) inhibitors within 4 weeks of Visit 1 and during the double-blind treatment period (e.g. clarithromycin, ritonavir, ketoconazole, itraconazole)
  • Inhaled anti-cholinergics (e.g. tiotropium, ipratropium)
  • Anti-IgE (e.g. Xolair [omalizumab])
  • Other immunomodulators (e.g. azathioprine, cyclosporine, methotrexate)
  • Anticonvulsants (barbiturates, hydantoins and carbamazepine)
  • Polycyclic antidepressants
  • beta-adrenergic blocking agents
  • Phenothiazines
  • Monoamine oxidase (MAO inhibitors)

研究者

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