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临床试验/NCT01883427
NCT01883427已完成2 期

Placebo Controlled Study Among Children Below Four Years of Age, Investigating Whether a Glucose Oxidase Nasal Spray Can Reduce Days With Upper Respiratory Tract Infection Symptoms

Krister Tano1 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2012年10月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
2 期
状态
已完成
发起方
入组人数
40
试验地点
1
主要终点
Respiratory Infectious Symptoms

研究概览

简要总结

To investigate if use of glucosoxidas nasal spray can reduce the number of days with upper respiratory tract infections in children beyond 4 years.

详细描述

Children below 4 years of age and in public day care were invited to participate in this prospective study. The children started with a visit to an ENT doctor and after inclusion the children started to spray twice daily with glucose oxidase+glucose or only saline+glucose for 3 months. During this period the parents were asked to fill in a home protocol recording upper respiratory tract symptoms as: rhinitis, cough, fever, ear ache. After 6 weeks and 12 weeks the children had scheduled visits to the ENT department, where an ENT doctor examined the throat, nasal cavity and the ear drums for otitis media. After 12 weeks of treatment a nasopharyngeal swab was taken for bacterial culture.

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
— 至 3 Years(Child)
性别
All
接受健康志愿者

入选标准

  • Children below 4 years of age

排除标准

  • 未提供

研究组 & 干预措施

Placebo: Saline+glucose nasal spray

Placebo Comparator

Subjects received nasal spray containing both saline+glucose twice daily for 3 months

干预措施: Placebo (Drug)

Nasal spray with glucose oxidase+glucose

Active Comparator

Nasal spray in a bag-on-valve device with 50U/ml containing both glucose oxidase + 5% glucose in isotone saline. Dosage: One puff in each nostril twice daily for 3 months.

干预措施: Glucose oxidase (Drug)

结局指标

主要结局

Respiratory Infectious Symptoms

时间窗: 3 months of recording

Days with upper respiratory tract infection symptoms during a 3 months period are recorded in a home protocol by the parents of the children.

次要结局

未报告次要终点

研究者

发起方
Krister Tano
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Krister Tano

MD, PhD

Umeå University

研究点 (1)

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