Randomised Controlled Trial of Rhinothermy for Treatment of the Common Cold: a Feasibility Study

Overview

Journal BMJ Open

Specialty General Medicine

Date 2018 Mar 30

PMID 29593018

Citations 2

Authors

Susanne van de Hei

Steven McKinstry

George Bardsley

Mark Weatherall

Richard Beasley

James Fingleton

Affiliations

Soon will be listed here.

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.

Citing Articles

Rhinothermy delivered by nasal high flow therapy in the treatment of the common cold: a randomised controlled trial.

Bird G, Braithwaite I, Harper J, Koorevaar I, van den Berg M, Maijers I BMJ Open. 2021; 11(11):e047760.

PMID: 34848508 PMC: 8634207. DOI: 10.1136/bmjopen-2020-047760.

Protocol for a randomised, single-blind, two-arm, parallel-group controlled trial of the efficacy of rhinothermy delivered by nasal high flow therapy in the treatment of the common cold.

Bird G, Braithwaite I, Harper J, McKinstry S, Koorevaar I, Fingleton J BMJ Open. 2019; 9(6):e028098.

PMID: 31221888 PMC: 6589000. DOI: 10.1136/bmjopen-2018-028098.

References

Singh M, Singh M . Heated, humidified air for the common cold. Cochrane Database Syst Rev. 2013; (6):CD001728. DOI: 10.1002/14651858.CD001728.pub5. View

Harris P, Taylor R, Thielke R, Payne J, Gonzalez N, Conde J . Research electronic data capture (REDCap)--a metadata-driven methodology and workflow process for providing translational research informatics support. J Biomed Inform. 2008; 42(2):377-81. PMC: 2700030. DOI: 10.1016/j.jbi.2008.08.010. View

Bramley T, Lerner D, Sames M . Productivity losses related to the common cold. J Occup Environ Med. 2002; 44(9):822-9. DOI: 10.1097/00043764-200209000-00004. View

Ridgeon E, Young P, Bellomo R, Mucchetti M, Lembo R, Landoni G . The Fragility Index in Multicenter Randomized Controlled Critical Care Trials. Crit Care Med. 2016; 44(7):1278-84. DOI: 10.1097/CCM.0000000000001670. View

Ophir D, Elad Y . Effects of steam inhalation on nasal patency and nasal symptoms in patients with the common cold. Am J Otolaryngol. 1987; 8(3):149-53. DOI: 10.1016/s0196-0709(87)80037-6. View

Walsh M, Srinathan S, McAuley D, Mrkobrada M, Levine O, Ribic C . The statistical significance of randomized controlled trial results is frequently fragile: a case for a Fragility Index. J Clin Epidemiol. 2014; 67(6):622-8. DOI: 10.1016/j.jclinepi.2013.10.019. View

Karsch-Volk M, Barrett B, Kiefer D, Bauer R, Ardjomand-Woelkart K, Linde K . Echinacea for preventing and treating the common cold. Cochrane Database Syst Rev. 2014; (2):CD000530. PMC: 4068831. DOI: 10.1002/14651858.CD000530.pub3. View

Oxford J, Corcoran T, Schild G . Naturally occurring temperature-sensitive influenza A viruses of the H1N1 and H3N2 subtypes. J Gen Virol. 1980; 48(Pt 2):383-9. DOI: 10.1099/0022-1317-48-2-383. View

Spyridaki I, Christodoulou I, de Beer L, Hovland V, Kurowski M, Olszewska-Ziaber A . Comparison of four nasal sampling methods for the detection of viral pathogens by RT-PCR-A GA(2)LEN project. J Virol Methods. 2008; 156(1-2):102-6. PMC: 7112903. DOI: 10.1016/j.jviromet.2008.10.027. View

10.

Brittain-Long R, Westin J, Olofsson S, Lindh M, Andersson L . Prospective evaluation of a novel multiplex real-time PCR assay for detection of fifteen respiratory pathogens-duration of symptoms significantly affects detection rate. J Clin Virol. 2010; 47(3):263-7. PMC: 7108433. DOI: 10.1016/j.jcv.2009.12.010. View

11.

Forstall G, Macknin M, Medendrop S . Effect of inhaling heated vapor on symptoms of the common cold. JAMA. 1994; 271(14):1109-11. View

12.

Kung H, JEN K, Yuan W, Tien S, Chu C . Influenza in China in 1977: recurrence of influenzavirus A subtype H1N1. Bull World Health Organ. 1978; 56(6):913-8. PMC: 2395678. View

13.

Foxman E, Storer J, Fitzgerald M, Wasik B, Hou L, Zhao H . Temperature-dependent innate defense against the common cold virus limits viral replication at warm temperature in mouse airway cells. Proc Natl Acad Sci U S A. 2015; 112(3):827-32. PMC: 4311828. DOI: 10.1073/pnas.1411030112. View

14.

Conti C, De Marco A, Mastromarino P, Tomao P, Santoro M . Antiviral effect of hyperthermic treatment in rhinovirus infection. Antimicrob Agents Chemother. 1999; 43(4):822-9. PMC: 89212. DOI: 10.1128/AAC.43.4.822. View

15.

De Sutter A, Saraswat A, Van Driel M . Antihistamines for the common cold. Cochrane Database Syst Rev. 2015; (11):CD009345. PMC: 9468790. DOI: 10.1002/14651858.CD009345.pub2. View

16.

Gwaltney Jr J, Hendley J, Patrie J . Symptom severity patterns in experimental common colds and their usefulness in timing onset of illness in natural colds. Clin Infect Dis. 2003; 36(6):714-23. PMC: 7109897. DOI: 10.1086/367844. View

17.

Corne J, Marshall C, Smith S, Schreiber J, Sanderson G, Holgate S . Frequency, severity, and duration of rhinovirus infections in asthmatic and non-asthmatic individuals: a longitudinal cohort study. Lancet. 2002; 359(9309):831-4. DOI: 10.1016/S0140-6736(02)07953-9. View

18.

Fendrick A, Monto A, Nightengale B, Sarnes M . The economic burden of non-influenza-related viral respiratory tract infection in the United States. Arch Intern Med. 2003; 163(4):487-94. DOI: 10.1001/archinte.163.4.487. View

19.

Heikkinen T, Jarvinen A . The common cold. Lancet. 2003; 361(9351):51-9. PMC: 7112468. DOI: 10.1016/S0140-6736(03)12162-9. View

20.

Heron I, Berg K . The actions of interferon are potentiated at elevated temperature. Nature. 1978; 274(5670):508-10. DOI: 10.1038/274508a0. View