Nasal airway obstruction study - NAIROS
| ISRCTN | ISRCTN16168569 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN16168569 |
| EudraCT/CTIS number | 2017-000893-12 |
| Secondary identifying numbers | 8302 |
- Submission date
- 06/03/2017
- Registration date
- 24/03/2017
- Last edited
- 13/03/2024
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Ear, Nose and Throat
Plain English Summary
Background and study aims
A deviated septum is a condition where the thin wall separating the nostrils (nasual septum) is off-center or crooked (deviation). Most people only have a minor deviation, but it can lead to difficulty breathing, snoring and a blocked nose. A septoplasty is a type of operation that corrects a deviated septum by removing excess bone and cartilage to straighten the septum and nasal passages. Like any operation, there is a risk of complications. Most patients need to take at least 5 days off work or usual activities after the operation. Some patients seem not much better after the surgery. Practice varies around the country, and there is no good evidence about this operation or its alternatives, or about who might benefit most from treatment, to inform help patients and doctors decide when it should be carried out. The aim of this study is to compare the effectiveness septoplasty or non-surgical care (medical management), which consists of nasal sprays in the management of adults with deviated septums.
Who can participate?
Adults with have a deviated septum.
What does the study involve?
Participants are randomly allocated to one of two groups. Those in the first group are treated surgically using a septoplasty procedure. Those in the second group are given a six month supply of two different nasal sprays, each to use twice daily. At the start of the study and then again after six and 12 months, participants in both groups complete a number of questionnaire in order to assess their quality of life, nasal symptoms and how much they are using health care services as well as a test to measure how well they are breathing through their noses.
What are the possible benefits and risks of participating?
Participants may benefit from improvement in symptoms of nasal blockage, sleep disturbance and congestion/headache if these symptoms are related to blocked nose due to a deviated septum. For participants who receive the nasal spray, there is a risk of bleeding or irritation in the nose. For those who receive surgery, there is a risk of general complications from surgery, including minor bleeding, discomfort (common), heavy bleeding, temporary numbness of central upper teeth, hole in the septum (perforation) and cosmetic change in the appearance of nose (rare).
Where is the study run from?
Freeman Hospital (lead centre) and 15 other NHS hospitals in England, Scotland and Wales (UK)
When is the study starting and how long is it expected to run for?
March 2017 to June 2021
Who is funding the study?
National Institute for Health Research, Health Technology Assessment Programme (UK)
Who is the main contact?
1. Dr Sean Carrie (scientific)
2. Dr Katherine Rennie (public)
nairos.trial@newcastle.ac.uk
Contact information
Scientific
Freeman Hospital
High Heaton
Newcastle Upon Tyne
NE7 7DN
United Kingdom
Public
Newcastle University Clinical Trials Unit
Newcastle University
1-4 Claremont Terrace
Newcastle Upon Tyne
NE2 4AE
United Kingdom
 ORCID ID |
0000-0003-1703-3768 |
|---|---|
| Phone | +44 (0)191 208 2519 |
| nairos.trial@newcastle.ac.uk |
Study information
| Study design | Multi-centre randomized controlled trial with qualitative process and economic evaluation |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use the contact details to request a patient information sheet. |
| Scientific title | Multicentre RCT to determine the clinical and cost effectiveness of septoplasty compared with non-surgical strategy in the management of nasal septal deviation in adult patients with nasal airway obstruction in the presence of a deviated nasal septum, what is effectiveness of septal surgery with turbinate reduction compared with 6 months’ topical nasal treatment in improving nasal symptoms |
| Study acronym | NAIROS |
| Study hypothesis | The aim of this study is to determine whether and to what extent septoplasty is superior to medical treatment in the management of adult patients with nasal obstruction in the presence of a septal deviation. |
| Ethics approval(s) | North East – Newcastle & North Tyneside 2 Research Ethics Committee, 31/08/2017, ref: 17/NE/0239 |
| Condition | Deviated septum |
| Intervention | Patients will be randomised to one of two groups in a 1:1 ratio using a variable block stratified design stratified by severity (baseline self-report NOSE category – moderate 30-50; Severe 55-75; extreme 80-100) and gender. Surgery: Participants will undergo septoplasty and turbinate reduction Medical management: Participants receive medical management, which will comprise of regular use of a nasal saline spray (sterimar) followed by a fluorinated steroid spray Mometasone for 6 months. All patients will be followed up at 6 and 12 months post randomisation. |
| Intervention type | Mixed |
| Primary outcome measure | Patient reported assessment of nasal and general symptoms is assessed using the SNOT 22 questionnaire (Sinonasal Outcome Test) at baseline, 6 and 12 months. |
| Secondary outcome measures | 1. Objective assessment nasal airflow is measured using rhinospirometry (nasal partitioning ratio and peak nasal airflow measurements) at baseline, 6 and 12 months 2. Quality of life is measured using the Short Form 36 Quality of Life Questionnaire at baseline, 6 and 12 months 3. Health utilisation is measured using a health utilisation questionnaire at baseline, 6 and 12 months |
| Overall study start date | 01/03/2017 |
| Overall study end date | 04/03/2021 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | 378 |
| Total final enrolment | 378 |
| Participant inclusion criteria | 1. Adults aged ≥18 years with a baseline NOSE score ≥30 2. Septal Deflection visible at naseondoscopy 3. Capacity to provide informed written consent and complete the study questionnaires. |
| Participant exclusion criteria | 1. Patients <18 years 2. Patients with a baseline NOSE score <30 3. Any prior septal surgery 4. Systemic inflammatory disease 5. Granulomatosis with poly angiitis 6. Naseondoscopic evidence of unrelated associated pathology eg. adenoid pad, septal perforation, chronic rhinosinusitis indicated by the prescence of polyposis or pus 7. Intranasal recreational drug use 8. Breastfeeding, pregnancy or intended pregnancy 9. Bleeding diathesis 10. Therapeutic anticoagulation 11. Known adverse reactions to general anaesthesia 12. Immunocompromised patients |
| Recruitment start date | 01/09/2017 |
| Recruitment end date | 31/01/2020 |
Locations
Countries of recruitment
- England
- Scotland
- United Kingdom
- Wales
Study participating centres
Newcastle Upon Tyne
NE7 7DN
United Kingdom
Aberdeen
AB25 2ZN
United Kingdom
Edgbaston
Birmingham
B15 2TH
United Kingdom
Bradford
BD9 6RJ
United Kingdom
Darlington
DL3 6HX
United Kingdom
Dundee
DD1 9SY
United Kingdom
Airdrie
ML6 OJS
United Kingdom
Leeds
LS1 3EX
United Kingdom
Liverpool
L9 7AL
United Kingdom
Newport
NP20 2UB
United Kingdom
Carlisle
CA2 7HY
United Kingdom
Plymouth
PL6 8DH
United Kingdom
Salisbury
SP2 8BJ
United Kingdom
Appley Bridge
Wigan
WN6 9EP
United Kingdom
London
SE1 9RT
United Kingdom
Norwich
NR4 7UY
United Kingdom
Sponsor information
Research organisation
Newcastle Joint Research Office
Regent Point
Regent Farm Road
Newcastle Upon Tyne
NE3 3HD
United Kingdom
| Website | http://www.newcastlejro.org.uk/ |
|---|---|
"ROR" |
https://ror.org/05p40t847 |
Funders
Funder type
Government
Government organisation / National government
- Alternative name(s)
- National Institute for Health Research, NIHR Research, NIHRresearch, NIHR - National Institute for Health Research, NIHR (The National Institute for Health and Care Research), NIHR
- Location
- United Kingdom
Results and Publications
| Intention to publish date | 31/10/2021 |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Data sharing statement to be made available at a later date |
| Publication and dissemination plan | Findings will be presented at international academic meetings and published in peer-reviewed journals. Publication of the results of the study will follow CONSORT guidelines for reporting clinical trials and NIHR guidance on communication research outcomes. Findings will also be distributed via ENTUK and ENT Scotland, and via primary care networks and conferences – including meetings of the Royal College of General Practitioners. The Royal Society of Medicine’s Sections also have a good track record of multidisciplinary meetings where the implications of NAIROS might usefully be discussed. The results will also be publicised in national media, with the aid of press releases from the Newcastle upon Tyne Hospitals Foundation Trust and Newcastle Universities. The domain name www.nairos.com has been purchases and will be used as a means of retaining stakeholder engagement and, thereafter, publicising the results. |
| IPD sharing plan | The current data sharing plans for the current study are unknown and will be made available at a later date. |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Protocol article | protocol | 13/02/2020 | 17/02/2020 | Yes | No |
| Basic results | 17/12/2021 | 16/06/2022 | No | No | |
| HRA research summary | 28/06/2023 | No | No | ||
| Results article | 18/10/2023 | 19/10/2023 | Yes | No | |
| Results article | 13/03/2024 | 13/03/2024 | Yes | No |
Editorial Notes
13/03/2024: Publication reference added.
19/10/2023: Publication reference added.
16/06/2022: EU Clinical Trials Register results added.
04/11/2021: The study contact emails have been updated and the plain English summary has been updated accordingly.
04/03/2021: The overall end date was changed from 30/06/2021 to 04/03/2021.
10/11/2020: The following changes were made to the trial record:
1. The overall end date was changed from 30/11/2020 to 30/06/2021.
2. The recruitment end date was changed from 30/04/2019 to 31/01/2020.
3. The total final enrolment was added.
4. The participant information sheet was changed from No participant information sheet available to Not available in web format, please use the contact details to request a patient information sheet.
5. The plain English summary was updated to reflect these changes.
17/02/2020: Publication reference added.
24/04/2018: The contact details were updated.
04/09/2017: Ethics approval information has been updated.
