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

NCT03704415 | Completed DMC

• 1 other identifier: AirGOs Operative
• Study Type: interventional
• Target: 97
• Locations: 2 countries
• Sites: 3

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.

Conditions

Sinusitis, Chronic; Asthma; Nasal Polyps; Aspirin Sensitivity

Outcome Measures

Primary Outcomes (1)

• 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.

  Baseline, Post-intervention every 3 months during 2 years

Study Arms (2)

Extended

ACTIVE COMPARATOR

Extended sinus surgery including all sinuses

Procedure: Extended endoscopic sinus surgery

Limited

ACTIVE COMPARATOR

Limited sinus surgery with partial ethmoidectomy

Procedure: Limited endoscopic sinus surgery

Interventions

Extended endoscopic sinus surgery PROCEDURE

ESS of all sinuses

Extended

Limited endoscopic sinus surgery PROCEDURE

Partial ethmoidectomy

Limited

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Helsinki University Central Hospital: lead

Study Sites (3)

Department of Otorhinolaryngology, Helsinki University Hospital

Helsinki, 00380, Finland

Location

Kuopio University Hospital

Kuopio, Finland

Location

Academic Medical Center

Amsterdam, 1105, Netherlands

Location

MeSH Terms

Conditions

Sinusitis; Bronchiolitis Obliterans Syndrome; Asthma; Nasal Polyps

Condition Hierarchy (Ancestors)

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

Study Officials

• Paula Virkkula, Docent

  Helsinki University Central Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chief Physician in Rhinology

Study Record Dates

• First Submitted: October 8, 2018
• First Posted: October 12, 2018
• Study Start: October 23, 2018
• Primary Completion: October 23, 2024
• Study Completion: October 23, 2024
• Last Updated: March 18, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: Beginning 3 months and ending 3 years after article publication.
• Access Criteria: Researchers who provide a methodologically sound proposal.

Locations

NL (1); FI (2)