Steam inhalation and Nasal Irrigation For recurrent Sinusitis

ISRCTN ISRCTN88204146
DOI https://doi.org/10.1186/ISRCTN88204146
Secondary identifying numbers Sponsor ref: RSO 3493
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

Study designPragmatic randomised controlled 2 x 2 factorial trial
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)GP practice
Study typeTreatment
Participant information sheet Not available in web format, please use the contact details to request a patient information sheet
Scientific titleA primary care randomised controlled trial of nasal irrigation and steam inhalation for recurrent sinusitis
Study acronymSNIFS
Study objectivesSinusitis 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) studiedSinusitis
InterventionTreatment 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 typeOther
Primary outcome measureSeverity 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 measuresFrom 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 study start date01/12/2008
Completion date10/07/2011

Eligibility

Participant type(s)Patient
Age groupAdult
Lower age limit18 Years
Upper age limit65 Years
SexBoth
Target number of participantsMinimum of 220 and maximum of 316
Key inclusion criteriaPatients (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 criteria1. 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 enrolment01/12/2008
Date of final enrolment10/07/2011

Locations

Countries of recruitment

  • England
  • United Kingdom

Study participating centre

University of Southampton
Southampton
SO16 5ST
United Kingdom

Sponsor information

University of Southampton (UK)
University/education

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

Website http://www.southampton.ac.uk
ROR logo "ROR" https://ror.org/01ryk1543

Funders

Funder type

Government

Programme Grants for Applied Research (ref: RP-PG-0407-10098)
Government organisation / National government
Alternative name(s)
NIHR Programme Grants for Applied Research, PGfAR
Location
United Kingdom

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot provided at time of registration
Publication and dissemination planNot 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

Editorial Notes

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