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Published in: Trials 1/2020

01-12-2020 | Mometasone | Study protocol

Nasal Airway Obstruction Study (NAIROS): a phase III, open-label, mixed-methods, multicentre randomised controlled trial of septoplasty versus medical management of a septal deviation with nasal obstruction

Authors: Katherine J. Rennie, James O’Hara, Nikki Rousseau, Deborah Stocken, Denise Howel, Laura Ternent, Mike Drinnan, Alison Bray, Leila Rooshenas, David W. Hamilton, Alison Steel, Tony Fouweather, Ann-Marie Hynes, Eva-Maria Holstein, Yemi Oluboyede, Alaa Abouhajar, Janet A. Wilson, Sean Carrie, for the NAIROS Study Group

Published in: Trials | Issue 1/2020

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Abstract

Background

Septoplasty (surgery to straighten a deviation in the nasal septum) is a frequently performed operation worldwide, with approximately 250,000 performed annually in the US and 22,000 in the UK. Most septoplasties aim to improve diurnal and nocturnal nasal obstruction. The evidence base for septoplasty clinical effectiveness is hitherto very limited.

Aims

To establish, and inform guidance for, the best management strategy for individuals with nasal obstruction associated with a deviated septum.

Methods/design

A multicentre, mixed-methods, open label, randomised controlled trial of septoplasty versus medical management for adults with a deviated septum and a reduced nasal airway. Eligible patients will have septal deflection visible at nasendoscopy and a nasal symptom score ≥ 30 on the NOSE questionnaire. Surgical treatment comprises septoplasty with or without reduction of the inferior nasal turbinate on the anatomically wider side of the nose. Medical management comprises a nasal saline spray followed by a fluorinated steroid spray daily for six months. The recruitment target is 378 patients, recruited from up to 17 sites across Scotland, England and Wales. Randomisation will be on a 1:1 basis, stratified by gender and severity (NOSE score). Participants will be followed up for 12 months post randomisation. The primary outcome measure is the total SNOT-22 score at 6 months. Clinical and economic outcomes will be modelled against baseline severity (NOSE scale) to inform clinical decision-making. The study includes a recruitment enhancement process, and an economic evaluation.

Discussion

The NAIROS trial will evaluate the clinical effectiveness and cost-effectiveness of septoplasty versus medical management for adults with a deviated septum and symptoms of nasal blockage. Identifying those individuals most likely to benefit from surgery should enable more efficient and effective clinical decision-making, and avoid unnecessary operations where there is low likelihood of patient benefit.

Trial registration

EudraCT: 2017–000893-12, ISRCTN: 16168569. Registered on 24 March 2017.
Appendix
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Metadata
Title
Nasal Airway Obstruction Study (NAIROS): a phase III, open-label, mixed-methods, multicentre randomised controlled trial of septoplasty versus medical management of a septal deviation with nasal obstruction
Authors
Katherine J. Rennie
James O’Hara
Nikki Rousseau
Deborah Stocken
Denise Howel
Laura Ternent
Mike Drinnan
Alison Bray
Leila Rooshenas
David W. Hamilton
Alison Steel
Tony Fouweather
Ann-Marie Hynes
Eva-Maria Holstein
Yemi Oluboyede
Alaa Abouhajar
Janet A. Wilson
Sean Carrie
for the NAIROS Study Group
Publication date
01-12-2020
Publisher
BioMed Central
Keyword
Mometasone
Published in
Trials / Issue 1/2020
Electronic ISSN: 1745-6215
DOI
https://doi.org/10.1186/s13063-020-4081-1

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