Contact information
Type
Scientific
Primary contact
Prof Paul Little
ORCID ID
Contact details
Primary Medical Care
University of Southampton
School of Medicine
Aldermoor Health Centre
Aldermoor Close
Southampton
SO16 5ST
United Kingdom
+44 (0)2380 241050
p.little@soton.ac.uk
Additional identifiers
EudraCT number
ClinicalTrials.gov 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
Acronym
SNIFS
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
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
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
Interventional
Secondary study design
Randomised controlled trial
Trial setting
GP practices
Trial type
Treatment
Patient information sheet
Condition
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
Phase
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
01/12/2008
Overall trial end date
10/07/2011
Reason abandoned
Eligibility
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
Patient
Age group
Adult
Gender
Both
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
01/12/2008
Recruitment end date
10/07/2011
Locations
Countries of recruitment
United Kingdom
Trial participating centre
Primary Medical Care
Southampton
SO16 5ST
United Kingdom
Sponsor information
Organisation
University of Southampton (UK)
Sponsor details
c/o Dr Martina Dorward
Legal Services
Highfield
Southampton
SO17 1BJ
United Kingdom
Sponsor type
University/education
Website
Funders
Funder type
Government
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
Location
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 http://www.ncbi.nlm.nih.gov/pubmed/27431306