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

Helsinki University Central Hospital97 enrolled

Overview

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.

Please see study protocol

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Sinusitis, Chronic Asthma Nasal Polyps Aspirin Sensitivity

Interventions

Eligibility

Sex: ALLMin age: 18 YearsMax age: 65 Years

Medical Language ↔ Plain English

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.

Locations (3)

Department of Otorhinolaryngology, Helsinki University Hospital

Helsinki, Finland

Kuopio University Hospital

Kuopio, Finland

Academic Medical Center

Amsterdam, Netherlands

Outcomes

Primary Outcomes

Sino-nasal outcome test (SNOT-22)

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.

Time frame: Baseline, Post-intervention every 3 months during 2 years