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

Fisher and Paykel Healthcare Limited0 个研究点目标入组 140 人开始时间: 2017年9月18日最近更新: 2019年8月26日

适应症

试验速览

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•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 POSITIVE test for Influenza A or B viruses using the GeneXpert® Xpress Flu/RSV point-of-care test (Cepheid, Ca, USA)

•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 NEGATIVE influenza point of care screening test.
•Known pregnancy or a positive pregnancy test during screening.

发起方

Fisher and Paykel Healthcare Limited