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Randomised controlled trial of rhinothermy for treatment of the common cold: a feasibility study.
BMJ Open 2018; 8(3):e019350BO

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.

Authors+Show Affiliations

Medical Research Institute of New Zealand, Wellington, New Zealand. University of Groningen, Groningen, The Netherlands.Medical Research Institute of New Zealand, Wellington, New Zealand. Victoria University of Wellington, Wellington, New Zealand. Capital and Coast District Health Board, Wellington, New Zealand.Medical Research Institute of New Zealand, Wellington, New Zealand. Capital and Coast District Health Board, Wellington, New Zealand.Capital and Coast District Health Board, Wellington, New Zealand. University of Otago, Wellington, New Zealand.Medical Research Institute of New Zealand, Wellington, New Zealand. Victoria University of Wellington, Wellington, New Zealand. Capital and Coast District Health Board, Wellington, New Zealand.Medical Research Institute of New Zealand, Wellington, New Zealand. Victoria University of Wellington, Wellington, New Zealand. Capital and Coast District Health Board, Wellington, New Zealand.

Pub Type(s)

Journal Article
Randomized Controlled Trial
Research Support, Non-U.S. Gov't

Language

eng

PubMed ID

29593018

Citation

Hei, Susanne van de, et al. "Randomised Controlled Trial of Rhinothermy for Treatment of the Common Cold: a Feasibility Study." BMJ Open, vol. 8, no. 3, 2018, pp. e019350.
Hei SV, McKinstry S, Bardsley G, et al. Randomised controlled trial of rhinothermy for treatment of the common cold: a feasibility study. BMJ Open. 2018;8(3):e019350.
Hei, S. V., McKinstry, S., Bardsley, G., Weatherall, M., Beasley, R., & Fingleton, J. (2018). Randomised controlled trial of rhinothermy for treatment of the common cold: a feasibility study. BMJ Open, 8(3), pp. e019350. doi:10.1136/bmjopen-2017-019350.
Hei SV, et al. Randomised Controlled Trial of Rhinothermy for Treatment of the Common Cold: a Feasibility Study. BMJ Open. 2018 03 27;8(3):e019350. PubMed PMID: 29593018.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Randomised controlled trial of rhinothermy for treatment of the common cold: a feasibility study. AU - Hei,Susanne van de, AU - McKinstry,Steven, AU - Bardsley,George, AU - Weatherall,Mark, AU - Beasley,Richard, AU - Fingleton,James, Y1 - 2018/03/27/ PY - 2018/3/30/entrez PY - 2018/3/30/pubmed PY - 2018/9/18/medline KW - clinical trials KW - infectious diseases KW - respiratory medicine (see thoracic medicine) KW - virology SP - e019350 EP - e019350 JF - BMJ open JO - BMJ Open VL - 8 IS - 3 N2 - 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. SN - 2044-6055 UR - https://www.unboundmedicine.com/medline/citation/29593018/Randomised_controlled_trial_of_rhinothermy_for_treatment_of_the_common_cold:_a_feasibility_study_ L2 - http://bmjopen.bmj.com/cgi/pmidlookup?view=long&pmid=29593018 DB - PRIME DP - Unbound Medicine ER -