Name: NAIROS - Nasal AIRway Obstruction Study
Logo:
Acronym:
NAIROS
Summary & Eligibility:
Doctors do not know whether surgery (septoplasty) or medical management is the best method for treating problems with nasal airway obstruction (blocked nose) associated with a deviated septum. The aim of this study is to find out which treatment works better and which treatment should be used widely in the NHS. Patients who agree to take part are randomly allocated to either medical management or surgery. Medical management involves using a nasal steroid spray and a salt-water spray in each of nostril twice daily for 6 months to improve nasal airflow. Septoplasty is an operation under general anaesthetic to straighten the septum to improve nasal airflow. The septum is the part of the nose between the two nostrils.
General Inclusion Criteria:
- Adults aged ≥ 18 years
- Adequate scores on screening questionnaire
- Septal Deflection at baseline visible via nasoendoscopy
- Capacity to provide informed written consent and complete the trial questionnaires.
General Exclusion Criteria:
- Any prior septal surgery
- Systemic inflammatory disease or the use of any current oral steroid treatment within the past 2 weeks
- Granulomatosis with polyangiitis
- Evidence of any unrelated associated pathology
- Any current or prior intranasal recreational drug use
- Breast feeding, pregnancy or intended pregnancy for duration of involvement in the trial (12 months)
- Bleeding diathesis
- Therapeutic anticoagulation (Warfarin/NOAC therapy)
- Clinically significant contraindication to general anaesthesia
- Patients known to be immuno-compromised
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For full inclusion and exclusion criteria contact the InHANSE team.
Status: Open
Sponsor: The Newcastle upon Tyne Hospitals NHS Foundation Trust
Study Coordinator:
Dr Eva-Maria Holstein
Clinical Trial Administrator
Newcastle Clinical Trials Unit, Newcastle University
1-4 Claremont Terrace, Newcastle upon Tyne, NE2 4AE
Study Schema:
