Skip to content

Nasal airway obstruction study - NAIROS

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

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ISRCTN
Registry ID
ISRCTN16168569
Enrollment
378
Registered
2017-03-24
Start date
2017-09-01
Completion date
Unknown
Last updated
2026-07-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Deviated septum Ear, Nose and Throat Deviated septum

Interventions

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

Sponsors

Newcastle Upon Tyne NHS Foundation Trust
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 100 Years

Inclusion criteria

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.

Exclusion criteria

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

Design outcomes

Primary

MeasureTime frame
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

MeasureTime frame
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

Countries

England, Scotland, United Kingdom, Wales

Contacts

Public ContactKatherine Rennie
nairos.trial@newcastle.ac.uk+44 (0)191 208 2519

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Jul 23, 2026