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

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.

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Key information

Conditions

Sinusitis, Chronic Aspirin Sensitivity Asthma Bronchial Diseases Bronchiolitis Bronchiolitis Obliterans Bronchiolitis Obliterans Syndrome Bronchitis Graft vs Host Disease Hypersensitivity Hypersensitivity, Immediate Immune System Diseases Infections Lung Diseases Lung Diseases, Obstructive Nasal Polyps Nose Diseases Organizing Pneumonia Otorhinolaryngologic Diseases Paranasal Sinus Diseases Pathological Conditions, Anatomical Pathological Conditions, Signs and Symptoms Polyps Respiratory Hypersensitivity Respiratory Tract Diseases Respiratory Tract Infections Sinusitis

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Department of Otorhinolaryngology, Helsinki University Hospital, Helsinki, Finland

About this study

Please see study protocol

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Extended endoscopic sinus surgery

Procedure

ESS of all sinuses

Limited endoscopic sinus surgery

Procedure

Partial ethmoidectomy

Primary outcomes

Sino-nasal outcome test (SNOT-22)

Time frame: 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.

Sponsors and collaborators

Lead sponsor

Helsinki University Central Hospital

Other

Registry information

Important dates

Study start: 2018
Primary completion: 2024
Study completion: 2024
First posted: Oct 12, 2018
Registry last updated: Mar 18, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed