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

Helsinki University Central Hospital (HUCH)

Status: Completed

Conditions: Asthma; Nasal Polyps; Sinusitis, Chronic; Aspirin Sensitivity

Treatments: Procedure: Extended endoscopic sinus surgery; Procedure: Limited endoscopic sinus surgery

Study type: Interventional

Funder types: Other

Identifiers

NCT03704415

AirGOs Operative

Details and patient eligibility

About

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.

Full description

Please see study protocol

Enrollment: 97 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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97 participants in 2 patient groups

Extended

Active Comparator group

Description:

Extended sinus surgery including all sinuses

Treatment:

Procedure: Extended endoscopic sinus surgery

Limited

Active Comparator group

Description:

Limited sinus surgery with partial ethmoidectomy

Treatment:

Procedure: Limited endoscopic sinus surgery