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临床试验/ACTRN12617001340325
ACTRN12617001340325已完成未知

A randomised, single blind, two arm, parallel group controlled trial of the efficacy of rhinothermy delivered by nasal high flow (rNHF) therapy in the treatment of the common cold

Fisher & Paykel Healthcare Limited0 个研究点目标入组 170 人开始时间: 2017年9月21日最近更新:
适应症

试验速览

阶段
未知
状态
已完成
入组人数
170

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
Treatment
盲法
Blinded (masking used)

入排标准

年龄范围
18 Years 至 75 Years(—)
性别
All

入选标准

  • Aged 18 to 75 years.
  • In the Investigator’s opinion, is able and willing to comply with all trial requirements.
  • Onset of symptoms within the last 48 hours at time of consent.
  • A NEGATIVE test for Influenza A and B viruses using the GeneXpert® Xpress Flu/RSV point-of-care test (Cepheid, Ca, USA)

排除标准

  • Immunocompromised condition:
  • o Conditions causing immunosuppression e.g. HIV/AIDS, active cancer
  • o Currently prescribed systemic steroids or other immunosuppressant medication
  • Nasal conditions such as deviated septum, chronic rhinitis, which the investigator considers could impair nasal breathing.
  • Current use of or requirement for oral antibiotics for respiratory tract infection, pneumonia or infective exacerbation of underlying respiratory condition.
  • Current use of or requirement for parenteral antibiotics.
  • Daily intra-nasal or inhaled steroids will be allowed if part of the participant’s regular therapy. If not taken prior to enrolment, they should be withheld for the duration of this study.
  • The investigator believes the participant or their care giver will be unable to safely use rNHF without medical supervision.
  • Have any other condition which, at the investigator’s discretion, is believed may present a safety risk or impact the feasibility of the study or the study results.
  • Have an implantable medical device.
  • Have a notifiable disease
  • Have existing travel plans that require them to leave the greater Wellington region during the first 5 days of the study (the period during which the participant will be using the rhinothermy device.
  • A current diagnosis of asthma, COPD or other significant respiratory conditions. (Participants who have not had asthma symptoms nor any requirement for asthma medication within the last 12 months, will be eligible for inclusion in the study.)
  • A positive influenza point of care screening test.

研究者

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