Condition category
Ear, Nose and Throat
Date applied
Date assigned
Last edited
Retrospectively registered
Overall trial status
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information



Primary contact

Prof Paul Little


Contact details

Primary Medical Care
University of Southampton
School of Medicine
Aldermoor Health Centre
Aldermoor Close
SO16 5ST
United Kingdom
+44 (0)2380 241050

Additional identifiers

EudraCT number number

Protocol/serial number

Sponsor ref: RSO 3493

Study information

Scientific title

A primary care randomised controlled trial of nasal irrigation and steam inhalation for recurrent sinusitis



Study hypothesis

Sinusitis is caused by the retention of sinus secretions creating a favourable milieu for infectious agents. This may be caused by:
1. Obstruction or narrowing of the sinus ostia by oedema or anatomical variants
2. Mucociliary dysfunction
3. Altered mucous composition with decreased elasticity or increased viscosity

1. Is nasal irrigation effective in reducing the symptoms of recurrent sinusitis?
2. Is steam inhalation effective in reducing the symptoms of recurrent sinusitis?
3. Is a combination of the two treatments more effective, of equal effectiveness or less effective than each of the individual treatments alone?

Ethics approval

Southampton & South West Hampshire Research Ethics Committee (B), 05/07/2007, ref: 07/Q1704/69

Study design

Pragmatic randomised controlled 2 x 2 factorial trial

Primary study design


Secondary study design

Randomised controlled trial

Trial setting

GP practices

Trial type


Patient information sheet




Treatment and follow-ups will be for a 6-month period.

Group 1. Daily nasal irrigation. Subjects will be asked to irrigate the nose (150 ml through each nostril) daily for 6 months. A neti pot will be provided to each subject and they will make their own buffered 2.0% saline irrigation solution every 1 to 2 days comprising 1 heaped teaspoon salt, on half teaspoon baking soda and 1 pint tap water. We have chosen this intervention based on the provisional evidence from the previous randomised controlled trial in primary care.

Group 2. Daily steam inhalation. Subjects will be asked to inhale steam for 5 minutes per day by placing a towel over the head over a bowl of recently boiled water. This intervention is chosen for its wide availability and ease of use rather than a particular device such as rhinotherm.

Group 3. Combined treatment group. Subjects will be asked to use both treatments daily, with nasal irrigation prior to steam. The feasibility phase will determine whether it is more feasible and acceptable for patients to do both interventions at the same time of day, and which order is preferable.

Group 4. Control group. Normal care.

Intervention type



Not Applicable

Drug names

Primary outcome measures

Severity of symptoms assessed by the Rhinosinusitis Disability Index (RSDI). During the feasibility stage RSDI and Sino-Nasal Outcome Test-20 (SNOT-20) will be recorded. Both are validated self-completion outcome measures for sinusitis. RSDI was used for the previous primary care study. It is anticipated that RSDI will be the primary outcome measure for this trial. However, if SNOT-20 is shown in the feasibility stage to be more sensitive to change it will be adopted as the primary outcome measure. Timepoints of assessment: 3 and 6 months.

Secondary outcome measures

From self-completion questionnaires at baseline, 3 and 6 months:
1. Quality of life assessed by the EQ-5D
2. Severity of sinus symptoms assessed by a Single-Item Sinus-Symptom Severity Assessment (SIA)
3. Severity of upper respiratory symptoms (coryza, sore throat, cough, earache, feeling unwell, fever) using format previously validated by our group
4. Belief in the importance of antibiotics and seeing the doctor for sinusitis using validated Likert scales

From a daily diary for one week of the study period at 3 months:
5. Side effects of treatment (and also reported side effects for previous 3 months)
6. Compliance with irrigation/inhalation (to minimise reporting bias, patients will be given 'permission' not to perform the intervention)
7. Use of over the counter treatments (e.g., analgesics, decongestants)

From notes review at the end of the follow-up period (at 6 months):
8. Number of prescriptions for antibiotics for sinus-related symptoms
9. Number of prescriptions for antibiotics in total
10. Number of GP visits regarding sinus-related symptoms and for other respiratory symptoms

Overall trial start date


Overall trial end date


Reason abandoned


Participant inclusion criteria

Patients (both males and females) aged 18-65 years with recurrent or chronic sinusitis. Patients will be identified from GPs' computerised notes: those who have presented to their GP with 2+ episodes of acute or 1+ episode of chronic sinusitis in the last 3 years, who report moderate to severe impact of sinusitis symptoms on the quality of life.

Participant type


Age group




Target number of participants

Minimum of 220 and maximum of 316

Participant exclusion criteria

1. Inability to complete outcome measures
2. Head and neck cancer
3. HIV
4. Immunosuppressive treatment
5. Cystic fibrosis
6. Pregnancy/breastfeeding
7. Other nasal disorders e.g., polyps or other defect obstructing sinus
8. Poor gag or swallow reflexes

Recruitment start date


Recruitment end date



Countries of recruitment

United Kingdom

Trial participating centre

Primary Medical Care
SO16 5ST
United Kingdom

Sponsor information


University of Southampton (UK)

Sponsor details

c/o Dr Martina Dorward
Legal Services
SO17 1BJ
United Kingdom

Sponsor type




Funder type


Funder name

National Institute for Health Research (NIHR) - Programme Grant for Applied Research (UK) (ref: RP-PG-0407-10098)

Alternative name(s)

Funding Body Type

Funding Body Subtype


Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

2016 results in

Publication citations

Additional files

Editorial Notes

21/07/2016: Publication reference added.