asal High Flow Rhinothermy (rNHF) in Influenza

Not Applicable

• Conditions: Influenza; Respiratory - Other respiratory disorders / diseases; Infection - Other infectious diseases

• Registration Number: ACTRN12617001331325
• Lead Sponsor: Fisher and Paykel Healthcare Limited

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2017-09-18
• Last Update Posted: 26 August 2019

Recruitment & Eligibility

• Status: Stopped early
• Sex: All
• Target Recruitment: 140

Inclusion Criteria

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)

Exclusion Criteria

• 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.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
To compare the area under the curve (AUC) quantitative PCR influenza log10 viral load (Day 1 to Day 5) between the treatment groups using Quantitative PCR influenza log10 viral load Days 1, 3 and 5 per Canterbury District Health Board; Canterbury Health Laboratories (CDHB: CHL) laboratory testing. <br>The influenza viral load is assessed from the nasopharyngeal swabs taken on Days 1, 3 and 5.[Day 1 (primary time point), 3 and 5]