Condition category
Respiratory
Date applied
13/02/2019
Date assigned
11/06/2019
Last edited
11/06/2019
Prospective/Retrospective
Prospectively registered
Overall trial status
Ongoing
Recruitment status
Not yet recruiting

Plain English Summary

Background and study aims
Acute sinus infections are one of the most common infections managed in primary care. Currently, GPs prescribe antibiotics to most patients presenting with sinusitis, the highest of any of the common acute infections presenting in adults, at over 90%. The trouble with prescribing for most people is that we are using antibiotics too much which is causing the bacteria to become resistant, which is likely to lead in the future to serious infections becoming untreatable from ‘superbugs’. Alternatives to the initial management with antibiotics are needed. Previous studies have tried nasal irrigation using salt solution for colds but the studies are small and not conclusive. There have also been studies of nasal irrigation in chronic sinus infections which do show some benefit. A large study in chronic or recurrent sinusitis in primary care showed that most people can learn to do nasal irrigation with simple advice and a short video to show how it is done, find it acceptable and will keep doing it over several weeks. However, there was some evidence that the approach to help people use nasal irrigation could be made more effective, dealing with key barriers or difficulties more effectively. There have been no good studies of saline irrigation in acute sinusitis. The aim of this study is to find out whether using nasal saline irrigation for managing acute sinusitis reduces the use of antibiotics.

Who can participate?
Patients aged 18 - 65 with acute recurrent sinusitis

What does the study involve?
Participants are randomly allocated to either immediate antibiotics (current usual treatment in primary care) or advice to do nasal irrigation for up to 3 weeks with a ‘back-up’ or delayed antibiotic prescription (a prescription that can be used if the sinusitis does not settle). Participants fill out a daily symptom diary to see whether irrigation makes any difference to symptom severity, or to the duration of illness, and whether antibiotics were used. Participants who are happy to have further tests have a swab of the nose.

What are the possible benefits and risks of participating?
This study will provide evidence of recruitment and follow-up rates, and is also likely to provide preliminary evidence about whether antibiotic use is likely to be reduced, in order to provide sufficient evidence for a larger application for a full trial. The benefits are potentially a reduction in antibiotic prescribing/use and help managing symptoms. For nasal irrigation there have been no serious side effects reported, the most common side effects being nasal stinging and sinus discomfort for some patients. If stinging occurs, participants will be advised to reduce the amount of salt in the saline mixture.

Where is the study run from?
1. University of Southampton (UK)
2. University of Bristol (UK)
3. University of Oxford (UK)

When is the study starting and how long is it expected to run for?
August 2018 to July 2020

Who is funding the study?
National Institute for Health Research School for Primary Care Research (UK)

Who is the main contact?
1. Tammy Thomas
tet@soton.ac.uk
2. Prof. Paul Little
p.little@soton.ac.uk

Trial website

Contact information

Type

Public

Primary contact

Ms Tammy Thomas

ORCID ID

http://orcid.org/0000-0003-4383-8586

Contact details

Primary Care & Population Sciences
University of Southampton
Aldermoor Close
Southampton
SO16 5ST
United Kingdom
+44 (0)2380 591773
tet@soton.ac.uk

Type

Scientific

Additional contact

Prof Paul Little

ORCID ID

http://orcid.org/0000-0003-3664-1873

Contact details

Primary Care & Population Sciences
University of Southampton
Aldermoor Close
Southampton
SO16 5ST
United Kingdom
+44 (0)2380 59 1759
p.little@soton.ac.uk

Additional identifiers

EudraCT number

Nil known

ClinicalTrials.gov number

Nil known

Protocol/serial number

V1 01/06/2018

Study information

Scientific title

SaliNe Irrigation For recurrent Sinusitis (SNIFSII)

Acronym

SNIFSII

Study hypothesis

1. The null hypothesis is that there is no difference between antibiotic utilisation rates between the strategy of providing immediate antibiotics and the alternative strategy of nasal irrigation and a delayed antibiotic prescription.
2. The alternative hypothesis is there are lower antibiotic utilisation rates when using nasal irrigation and a delayed antibiotic prescription compared with providing an immediate antibiotic prescription.

Ethics approval

Approval pending, Surrey NRES, Health Research Authority (Whitefriars, Level 3, Block B, HRA, BS1 2NT; Email: nrescommittee.secoast-surrey@nhs.net), REC ref: 19/LO/0620

Study design

Randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

GP practices

Trial type

Treatment

Patient information sheet

Not available in web format, please use contact details to request a participant information sheet

Condition

Sinusitis - URTI

Intervention

Participants are randomised to either:
1. Immediate antibiotics (current usual treatment in primary care)
2. Advice to do nasal irrigation for up to 3 weeks with a ‘back-up’ or delayed antibiotic prescription (a prescription that can be used if the sinusitis does not settle)

Participants will fill out a daily symptom diary to see whether irrigation makes any difference to symptom severity, or to the duration of illness, and whether antibiotics were used. Participants who are happy to have further tests will have a swab of the nose.

Sample size:
Feasibility estimates: to estimate follow-up rates in each group between 65% and 80%, to be reasonably sure that the follow-up rate is not 50% in each group (i.e.95% confidence intervals of +/- 15%) then 41 per group are needed. The researchers also anticipate that it should be possible for the intervention group to achieve use of antibiotics of around 65% or less. To estimate this proportion with 95% confidence intervals of +/- 15% (i.e. that antibiotic use is 80% or less) 41 per group is also needed. To allow for loss to follow-up more than 100 patients are needed.

Feasibility:
The previous JAMA trial recruited 238 individuals/4 years with one RA (one centre), but recruitment is currently more challenging. The researchers therefore estimate that with one RA at the coordinating centre and P/T RAs in two other centres will allow them to recruit their target efficiently in 2 winter seasons.

Intervention type

Behavioural

Phase

Drug names

Primary outcome measure

1. Antibiotic use measured using patient-reported symptom diary, completed over four weeks or until symptoms resolve.
2. Duration of moderately bad symptoms measured using a validated symptom diary; variables (using 7-point Likert scales): nasal blockage, discharge, unpleasant taste/smell, facial pain, pain on bending, impaired activities, generally unwell, sleep disturbance. Completed over four weeks or until symptoms resolve.

Secondary outcome measures

1. Symptom duration until little/no problem, measured using patient-reported symptom diary, completed over four weeks or until symptoms resolve
2. Mean symptom score measured using patient-reported symptom diary, completed over four weeks or until symptoms resolve
3. Development of new/worsening symptoms measured using patient-reported symptom diary, completed over four weeks or until symptoms resolve
4. Health-related quality of life measured using EQ5D, completed over four weeks or until symptoms resolve
5. Reconsultations/resource use during the next month measured using patient note reviews conducted by staff at the surgeries

Overall trial start date

01/08/2018

Overall trial end date

31/07/2020

Reason abandoned (if study stopped)

Eligibility

Participant inclusion criteria

The researchers pragmatically define acute sinusitis as having sinus discomfort and at least 2 other symptoms (2 of: patient-reported nasal obstruction, patient-reported purulent nasal discharge, or pus seen in the nasal cavity on inspection by the clinician).
They do not propose using prior duration (e.g. the requirement for at least 7 days without improvement in the Canadian guidelines) since there is no good evidence for a particular cut-off, and their aim is to help people who are currently being treatment with antibiotics for sinusitis, many of whom present with 7 days.

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

108

Participant exclusion criteria

1. Inability to complete outcomes (reduced capacity: dementia, severe uncontrolled mental illness; terminal illness etc)
2. Head/neck cancer
3. HIV
4. Immune-suppressive treatment
5. Cystic fibrosis
6. Pregnancy/breastfeeding
7. Other nasal disorders e.g. polyps; poor gag/swallow reflexes

Recruitment start date

01/08/2019

Recruitment end date

31/05/2020

Locations

Countries of recruitment

United Kingdom

Trial participating centre

University of Southampton
Primary Care & Population Sciences Faculty of Medicine Aldermoor Close
Southampton
SO16 5ST
United Kingdom

Trial participating centre

University of Bristol
School of Social and Community Medicine Room 1.01 Canynge Hall 39 Whatley Road
Bristol
BS8 2PS
United Kingdom

Trial participating centre

University of Oxford
Department of Primary Health Care Radcliffe Observatory Quarter Woodstock Road
Oxford
OX2 6GG
United Kingdom

Sponsor information

Organisation

University of Southampton

Sponsor details

Head of IP
Contracts and Policy
Research & Innovation Services
Highfield Campus
Southampton
SO17 1BJ
United Kingdom
+44 (0)2380595058
D.Galpin@soton.ac.uk

Sponsor type

University/education

Website

Funders

Funder type

Government

Funder name

National Institute for Health Research School for Primary Care Research

Alternative name(s)

NIHR

Funding Body Type

government organisation

Funding Body Subtype

National government

Location

United Kingdom

Results and Publications

Publication and dissemination plan

Planned publication in a high-impact peer-reviewed journal.

IPD sharing statement
The datasets generated during and/or analysed during the current study are/will be available upon request from Prof. Paul Little (p.little @soton.ac.uk). Type of data: quantitative trial data. When the data will become available and for how long: at the end of the feasibility study so probably by June 2021. If a reasonable proposal is made to the PI (Prof. Little) the data will be made available; in the unlikely event of a request being declined the Board of the NIHR SPCR will be the arbiter. All participants were consented, data will be anonymised, no ethical or legal restrictions.

Intention to publish date

31/07/2021

Participant level data

Available on request

Basic results (scientific)

Publication list

Publication citations

Additional files

Editorial Notes

28/05/2019: Trial's existence confirmed by the NIHR.