NAIROS
Research type
Research Study
Full title
Nasal Airway Obstruction Study
IRAS ID
222301
Contact name
Sean Carrie
Contact email
Sponsor organisation
Newcastle upon Tyne Hospitals NHS Foundation Trust
Eudract number
2017-000893-12
ISRCTN Number
ISRCTN16168569
Duration of Study in the UK
2 years, 11 months, 31 days
Research summary
Summary of Research
Septoplasty is surgery to straighten the part of the nose that divides the two nostrils (the septum). The surgery is carried out in the hope of improving symptoms such as a blocked nose, snoring and sleep disturbance. However not everyone is cured of their symptoms after the procedure. There is no good evidence to know who will benefit from this operation or its alternatives.NAIROS aims to provide this evidence by randomising patients’ ≥ 18 years of age to either septoplasty or medical care (medical management). The medical management is a 6 months’ course of mometasone furoate steroid spray (Nasonex) and a salt-water spray. The combination of these 2 sprays may help the symptoms of the blocked nose in some patients.
The study will take place in up to 17 NAIROS centres. Patients fill in questionnaires and have nasal patency measures carried out at the time of randomisation and 6 and 12 months thereafter. This trial plans to look at the changes before and after both surgery and medical treatment. This will allow us, at the end of the trial, to recommend which patients groups, if any, stand to gain most from a septoplasty operation?
We will look at NHS costs and patient costs due to nasal blockage. The QuinteT Recruitment Intervention will identify and address recruitment challenges, which include:
a. Mapping out patient pathways and scrutinising screening log data
b. Audio-recording discussions where health care professionals who try to recruit eligible patients
c. Interviews with staff involved in the trialThese interviews will help us to understand:
a. Why patients do or do not wish to take part in the trial?
b. Patients’ experiences of septoplasty and the medical arm
c. How to put the findings of the trial into practice.Summary of Results
Septoplasty is an operation to straighten the septum – the partition wall between the nostrils inside the nose. Septoplasty can be used as a treatment for people who have a bent septum and symptoms of a blocked nose like difficulty sleeping and exercising. An alternative treatment is medical management - a nose steroid spray plus a saltwater spray to help clear the nose before the steroid spray is used. NAIROS aimed to find out whether septoplasty or medical management is a better treatment for people with a bent septum and symptoms of a blocked nose. A total of 378 patients who had at least moderately severe nose symptoms from 17 hospitals in England, Scotland and Wales took part in NAIROS. Patients were randomly put into one of two groups – either septoplasty or medical management.
We measured patients’ nose symptoms when they joined the study and six months later, using a questionnaire called SNOT-22. We chose this questionnaire because patients had told us that it included symptoms that were important to them. Other studies have shown that a nine-point change in the SNOT-22 score is an important difference. We found that after six months, on average, people in the septoplasty group improved by 25 points whereas people in the medical management group improved by 5 points. We saw improvement after septoplasty for patients with moderate as well as those with severe symptoms. NAIROS suggests that septoplasty is beneficial for most people who have a bent septum and a moderately, or severely, blocked nose. In the short-term septoplasty is more costly than medical management but over time this difference is likely to get smaller.REC name
North East - Newcastle & North Tyneside 2 Research Ethics Committee
REC reference
17/NE/0239
Date of REC Opinion
31 Aug 2017
REC opinion
Further Information Favourable Opinion