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.

Study Overview

• Status: Completed
• Conditions: Asthma; Nasal Polyps; Aspirin Sensitivity; Sinusitis, Chronic
• Intervention / Treatment: Procedure: Extended endoscopic sinus surgery; Procedure: Limited endoscopic sinus surgery

Detailed Description

Please see study protocol

• Study Type: Interventional
• Enrollment (Actual): 97
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Finland
  • Helsinki, Finland, 00380
    • Department of Otorhinolaryngology, Helsinki University Hospital
  • Kuopio, Finland
    • Kuopio University Hospital
• Netherlands
  • Amsterdam, Netherlands, 1105
    • Academic Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Extended; Extended sinus surgery including all sinuses	Procedure: Extended endoscopic sinus surgery; ESS of all sinuses
Active Comparator: Limited; Limited sinus surgery with partial ethmoidectomy	Procedure: Limited endoscopic sinus surgery; Partial ethmoidectomy

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Helsinki University Central Hospital
• Investigators: Principal Investigator: Paula Virkkula, Docent, Helsinki University Central Hospital

Study record dates

Study Major Dates

• Study Start (Actual): October 23, 2018
• Primary Completion (Actual): October 23, 2024
• Study Completion (Actual): October 23, 2024

Study Registration Dates

• First Submitted: October 8, 2018
• First Submitted That Met QC Criteria: October 10, 2018
• First Posted (Actual): October 12, 2018

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: March 16, 2025
• Last Verified: March 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Pathological Conditions, Anatomical; Respiratory Tract Infections; Infections; Respiratory Tract Diseases; Nose Diseases; Otorhinolaryngologic Diseases; Paranasal Sinus Diseases; Polyps; Inflammation; Nasal Polyps; Sinusitis
• Other Study ID Numbers: AirGOs Operative

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Individual participant data that underlie the results reported in this article, after deidentification (text, tables, figures and appendices) can be shared.
• IPD Sharing Time Frame: Beginning 3 months and ending 3 years after article publication.
• IPD Sharing Access Criteria: Researchers who provide a methodologically sound proposal.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No