Aggravated Airway Inflammation: Research on Genomics and Optimal Operative Treatment (AirGOs Operative)

Not Applicable

Completed

• Conditions: Sinusitis, Chronic; Nasal Polyps; Aspirin Sensitivity; Asthma
• Interventions: Procedure: Limited endoscopic sinus surgery; Procedure: Extended endoscopic sinus surgery

• Registration Number: NCT03704415
• Lead Sponsor: Helsinki University Central Hospital

Brief Summary

This randomized study compares operative techniques in chronic rhinosinusitis with polyposis (CRSwNP) surgery. It aims to evaluate outcomes in asthma and CRSwNP, safety and costs. The investigators want to see if patients with certain clinical and/or genetic predispositions will benefit from extended surgery. They also aim to find biomarkers for detection and management models for of severe airway inflammation and to further develop markers for progressive disease forms.

Detailed Description

Please see study protocol

Study Timeline

• Study First Submitted: 2018-10-08
• Study First Submitted QC: 2018-10-10
• Study First Posted: 2018-10-12
• Study Start: 2018-10-23
• Primary Completion: 2024-10-23
• Study Completion: 2024-10-23
• Status Verified: 2025-03
• Last Update Submitted: 2025-03-16
• Last Update Posted: 2025-03-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 97

Inclusion Criteria

• Patient not responding to conservative treatment of 3 months of nasal steroid drops
• Nasal polyp score ≥ 4/8
• SNOT-22 ≥ 30
• Lund-Mackay CT score ≥ 14
• One previous endoscopic sinus surgery or at least one peroral corticosteroid course or at least 3 courses of antibiotics within 2 years

Exclusion Criteria

• Age <18 years, age > 65 years
• Complication of CRS (f.e. mucocele, invasive fungal rhinosinusitis)
• Other diagnosis than CRSwNP (inverted papilloma, antrochoanal polyp etc.)
• Previous external sinus surgery or Draf 3 procedure (or indication for external approaches or Draf 3
• Bleeding diathesis
• Pregnancy/ breastfeeding
• Cystic fibrosis
• Primary ciliary dyskinesia (PCD)
• Sarcoidosis
• Granulomatosis with polyangitis (GPA)
• Eosinophilic granulomatosis with polyangitis (EGPA)
• Immunosupression (diagnosed Spesific Antibody Deficiency (SAD), common variable immunodeficiency (CVI), HIV or use of biologicals/immunosuppressive medication)
• Immunotherapy
• Daily use of systemic corticosteroids
• Communication problems (f.e. neurological/psychiatric disease, language skills)
• Unlikely to comply
• Other severe disease
• Inability to be operated.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Limited	Limited endoscopic sinus surgery	Limited sinus surgery with partial ethmoidectomy
Extended	Extended endoscopic sinus surgery	Extended sinus surgery including all sinuses

Primary Outcome Measures

Name	Time	Method
Sino-nasal outcome test (SNOT-22)	Baseline, Post-intervention every 3 months during 2 years	Change from baseline in patient symptoms as measured by the Sino-Nasal Outcomes Test (SNOT-22) survey. Scores are measured from 0-5 in a 22 item validated survey. Total scores range from 0-110 with higher scores indicating greater burden of sinonasal symptoms.

Trial Locations

Locations (3)

Kuopio University Hospital; 🇫🇮 Kuopio, Finland

Academic Medical Center; 🇳🇱 Amsterdam, Netherlands

Department of Otorhinolaryngology, Helsinki University Hospital; 🇫🇮 Helsinki, Finland