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Respiratory medicine
Research
Randomised controlled trial of rhinothermy for treatment of the common cold: a feasibility study
  1. Susanne van de Hei1,2,
  2. Steven McKinstry1,3,4,
  3. George Bardsley1,4,
  4. Mark Weatherall4,5,
  5. Richard Beasley1,3,4,
  6. James Fingleton1,3,4
  1. 1 Medical Research Institute of New Zealand, Wellington, New Zealand
  2. 2 University of Groningen, Groningen, The Netherlands
  3. 3 Victoria University of Wellington, Wellington, New Zealand
  4. 4 Capital and Coast District Health Board, Wellington, New Zealand
  5. 5 University of Otago, Wellington, New Zealand
  1. Correspondence to Dr James Fingleton; james.fingleton{at}mrinz.ac.nz

Abstract

Objective To determine the feasibility of a randomised controlled trial (RCT) of rhinothermy for the common cold.

Design Open label, randomised, controlled feasibility study.

Setting Single-centre research institute in New Zealand recruiting participants from the community.

Participants 30 adult participants with symptoms of a common cold, presenting within 48 hours of the onset of symptoms.

Interventions Participants were randomly assigned 2:1 to receive either 35 L/min of 100% humidified air at 41°C via high flow nasal cannulae, 2 hours per day for up to 5 days (rhinothermy), or vitamin C 250 mg daily for 5 days (control).

Primary and secondary outcome measures The primary outcome was the proportion of screened candidates who were randomised. Secondary outcomes included: proportion of randomised participants who completed the study; modified Jackson scores from randomisation to 10 days after initiation of randomised regimen; time until feeling ‘a lot better’ compared with study entry; time until resolution of symptoms or symptom score at 10 days postrandomisation; proportion of organisms identified by PCR analysis of nasal swabs taken at baseline; the patterns of use of the rhinothermy device; estimated adherence of the control group; and rhinothermy device tolerability.

Results In all 30/79 (38%, 95% CI 27% to 50%) of potential participants screened for eligibility were randomised. Rhinothermy was well tolerated, and all randomised participants completed the study (100%, 95% CI 88% to 100%). The reduction from baseline in the modified Jackson score was greater with rhinothermy compared with control at days 2, 3, 4, 5 and 6, with the maximum difference at day 4 (−6.4, 95% CI −9.4 to −3.3). The substantial clinical benefit threshold for modified Jackson score was a 5-unit change.

Conclusions This study shows that an RCT of rhinothermy compared with low-dose vitamin C in the treatment of the common cold is feasible.

Trial registration number ACTRN12616000470493; Results.

  • infectious diseases
  • virology
  • clinical trials
  • respiratory medicine (see thoracic medicine)

This is an Open Access article distributed in accordance with the Creative Commons Attribution Non Commercial (CC BY-NC 4.0) license, which permits others to distribute, remix, adapt, build upon this work non-commercially, and license their derivative works on different terms, provided the original work is properly cited and the use is non-commercial. See: http://creativecommons.org/licenses/by-nc/4.0/

https://doi.org/10.1136/bmjopen-2017-019350

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    Footnotes

    • Contributors JF was the principal investigator for the study, is guarantor for the study and affirms that this manuscript is an honest, accurate and transparent account of the study being reported; that no important aspects of the study have been omitted; and that any discrepancies from the study as planned and registered have been explained. JF, SvdH, SM and GB were investigators on the study and collected the data. MW performed the statistical analysis. SvdH wrote the first draft of the manuscript. RB conceived the study and wrote the first draft of the protocol. All authors contributed to study design, interpretation of results, manuscript writing and reviewed the final manuscript prior to submission. All authors had full access to all of the data (including statistical reports and tables) in the study and can take responsibility for the integrity of the data and the accuracy of the data analysis. No writing assistance was received.

    • Funding The study was sponsored by Fisher & Paykel Healthcare Limited. The MRINZ receives Health Research Council of New Zealand Independent Research Organisation funding.

    • Disclaimer The sponsor was given the opportunity to comment on the manuscript prior to submission but had no role in the collection, analysis and interpretation of data; in the writing of the report; or in the decision to submit the article for publication.

    • Competing interests None declared.

    • Patient consent Not required.

    • Ethics approval The study was approved by the Northern B Ethics Health and Disability Ethics Committee of New Zealand (16/NTB/47).

    • Provenance and peer review Not commissioned; externally peer reviewed.

    • Data sharing statement Relevant anonymised patient level data are available on reasonable request.