Rhinothermy in the Common Cold (RiCC)

Not Applicable

Completed

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

• Registration Number: ACTRN12617001340325
• Lead Sponsor: Fisher & Paykel Healthcare Limited

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2017-09-21
• Study Completion: 2019-07-18
• Last Update Posted: 5 January 2021

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 170

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 NEGATIVE test for Influenza A and 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 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.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Day 4 Modified Jackson Symptom Score, as captured by participant daily symptom diary, adjusted for baseline (Day 1) modified Jackson Symptom Score.<br><br>The modified Jackson Score has previously been validated (Jackson GG, Dowling HF, Spiesman IG, et al. Transmission of the common cold to volunteers under controlled conditions. I. The common cold as a clinical entity. AMA Arch Intern Med 1958;101:267–78.http://www.ncbi.nlm.nih.gov/pubmed/13497324)[Day 4]