Steam inhalation and Nasal Irrigation For recurrent Sinusitis

ISRCTN	ISRCTN88204146
DOI	https://doi.org/10.1186/ISRCTN88204146
Protocol serial number	Sponsor ref: RSO 3493
Sponsor	University of Southampton (UK)
Funder	Programme Grants for Applied Research (ref: RP-PG-0407-10098)

Submission date: 05/01/2009
Registration date: 27/02/2009
Last edited: 06/11/2017

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Ear, Nose and Throat

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

Contact information

Prof Paul Little
Scientific

Primary Medical Care
University of Southampton
School of Medicine
Aldermoor Health Centre
Aldermoor Close
Southampton
SO16 5ST
United Kingdom

Phone	+44 (0)2380 241050
Email	p.little@soton.ac.uk

Study information

Primary study design	Interventional
Study design	Pragmatic randomised controlled 2 x 2 factorial trial
Secondary study design	Randomised controlled trial
Study type	Participant information sheet
Scientific title	A primary care randomised controlled trial of nasal irrigation and steam inhalation for recurrent sinusitis
Study acronym	SNIFS
Study objectives	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 Hypothesis: 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(s)	Southampton & South West Hampshire Research Ethics Committee (B), 05/07/2007, ref: 07/Q1704/69
Health condition(s) or problem(s) studied	Sinusitis
Intervention	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	Other
Primary outcome measure(s)	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.
Key secondary outcome measure(s)	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
Completion date	10/07/2011

Eligibility

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Upper age limit	65 Years
Sex	All
Target sample size at registration	316
Key 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.
Key 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
Date of first enrolment	01/12/2008
Date of final enrolment	10/07/2011

Locations

Countries of recruitment

United Kingdom
England

Study participating centre

University of Southampton

Southampton
SO16 5ST
United Kingdom

Results and Publications

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
IPD sharing plan

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	results	20/09/2016		Yes	No
Results article	nested qualitative interview study results	03/11/2017		Yes	No
Participant information sheet	Participant information sheet	11/11/2025	11/11/2025	No	Yes

Editorial Notes

06/11/2017: Publication reference added.
21/07/2016: Publication reference added.