asal Airway Obstruction Study - NAIROS

Phase 1

• Conditions: Deviated Nasal Septum; MedDRA version: 20.0Level: LLTClassification code 10034383Term: Perennial rhinitisSystem Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders; MedDRA version: 20.1Level: LLTClassification code 10039776Term: Seasonal allergic rhinitisSystem Organ Class: 100000004870; MedDRA version: 20.0Level: PTClassification code 10028756Term: Nasal polypsSystem Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders; Therapeutic area: Diseases [C] - Ear, nose and throat diseases [C09]

• Registration Number: EUCTR2017-000893-12-GB
• Lead Sponsor: The Newcastle Upon Tyne Hospitals NHS Foundation Trust

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2018-05-10
• Last Update Posted: 14 May 2018

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 378

Inclusion Criteria

• Adults aged = 18 years
• Baseline NOSE score =30
• Septal Deflection at baseline visible on examination via nasoendoscopy
• Capacity to provide informed written consent and complete the trial questionnaires
Participants are willing and able to provide full written informed consent

Are the trial subjects under 18? no
Number of subjects for this age range: 0
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 320
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 58

Exclusion Criteria

• Any prior septal surgery
• Systemic inflammatory disease or current oral steroid treatment
• Granulomatosis with polyangiitis
• Naso-endoscopic evidence of unrelated associated pathology e.g. adenoid pad, septal perforation, chronic rhinosinusitis indicated by the of polyposis or pus
• Any intranasal recreational drug use
• Breast feeding, pregnancy or intended pregnancy for duration of involvement in the trial
• Bleeding diathesis
• Therapeutic anticoagulation (Warfarin/NOAC therapy)
• Clinically significant contraindication to general anaesthesia
• Patients known to be immuno-compromised

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified