Assessing the feasibility of using nasal saline irrigation for managing acute sinusitis

Not Applicable

• Conditions: Sinusitis - URTI; Respiratory

• Registration Number: ISRCTN13373396
• Lead Sponsor: niversity of Southampton

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2019-06-11
• Study Completion: 2021-06-30
• Last Update Posted: 26 July 2021

Recruitment & Eligibility

• Sex: All
• Target Recruitment: 108

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.

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<br> 1. Antibiotic use measured using patient-reported symptom diary, completed over four weeks or until symptoms resolve.<br> 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.<br>

Secondary Outcome Measures

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