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CompletedNCT03704415Updated Mar 18, 2025

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

An interventional study of Extended endoscopic sinus surgery and Limited endoscopic sinus surgery in Sinusitis, Chronic, Asthma and Nasal Polyps, sponsored by Helsinki University Central Hospital. Completed at 3 sites in 2 countries. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2025-03-18.

Sponsored by Helsinki University Central Hospital · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
97
Allocation
Randomized
Ages
18 Years to 65 Years
Sex
All
01

Study 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.

Read the detailed description

Please see study protocol

02

Conditions studied

  • Sinusitis, Chronic
  • Asthma
  • Nasal Polyps
  • Aspirin Sensitivity
03

In context

Sinusitis

415 studies on the registry are indexed under Sinusitis; 46 are open to participants now.

This study's enrollment of 97 is above the median of 60 across 313 interventional studies indexed under Sinusitis.

Browse Sinusitis studies →

Lead sponsor

Helsinki University Central Hospital is the lead sponsor of 299 studies on the registry; 60 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 65 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

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.
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
97 participants (actual)

Study arms

  • Active comparator
    Extended

    Extended sinus surgery including all sinuses

    Procedure: Extended endoscopic sinus surgery

  • Active comparator
    Limited

    Limited sinus surgery with partial ethmoidectomy

    Procedure: Limited endoscopic sinus surgery

Interventions

  • ProcedureExtended endoscopic sinus surgery

    ESS of all sinuses

  • ProcedureLimited endoscopic sinus surgery

    Partial ethmoidectomy

06

What researchers measure

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.

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

07

Study locations

3 sites
  • Department of Otorhinolaryngology, Helsinki University Hospital
    Helsinki, 00380, Finland
  • Kuopio University Hospital
    Kuopio, Finland
  • Academic Medical Center
    Amsterdam, 1105, Netherlands
08

References and documents

Study documents

  • Protocol and statistical analysis plan · Aug 23, 2018

Documents are hosted by the registry — open the source record to download them.

Individual participant data

Plan to share: Yes — Individual participant data that underlie the results reported in this article, after deidentification (text, tables, figures and appendices) can be shared.

Supporting information: Study protocol, Sap

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 18, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03704415
Lead sponsor
Helsinki University Central Hospital
Responsible party
Paula Virkkula (Chief Physician in Rhinology, Helsinki University Central Hospital) — Principal investigator
First posted
Oct 12, 2018
Start date
Oct 23, 2018
Primary completion
Oct 23, 2024
Completion
Oct 23, 2024
Last update
Mar 18, 2025

Study contacts

Paula Virkkula, Docent
principal investigator · Helsinki University Central Hospital

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Mar 2025. You cannot join it, but the record below documents what was studied.

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