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

  • STATUS
    Recruiting
  • End date
    Dec 15, 2024
  • participants needed
    174
  • sponsor
    Helsinki University Central Hospital
Updated on 16 May 2021
antibiotic therapy
antibiotics
corticosteroids
rhinosinusitis
asthma
other disease
nasal polyp
sinus surgery
polyposis

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.

Description

Please see study protocol

Details
Condition Nasal polyp, Polyp, Polyps, Asthma, Asthma, Asthma (Pediatric), Allergies & Asthma, Allergies & Asthma, Asthma (Pediatric), Chronic Sinusitis, Chronic Rhinosinusitis, Sinusitis, Chronic, Aspirin Sensitivity, Polyps, Sinusitis, Chronic, Sinusitis, Chronic, asthmatic, bronchial asthma, nasal polyps
Treatment Extended endoscopic sinus surgery, Limited endoscopic sinus surgery
Clinical Study IdentifierNCT03704415
SponsorHelsinki University Central Hospital
Last Modified on16 May 2021

Eligibility

Yes No Not Sure

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
Clear my responses

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