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

Asthma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03704415
• Other study ID #: AirGOs Operative
• Status: Active, not recruiting
• Phase: N/A
• Start date: October 23, 2018
• Est. completion date: December 31, 2024

Study information

• Verified date: September 2023
• Source: Helsinki University Central Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 97
• Est. completion date: December 31, 2024
• Est. primary completion date: December 31, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

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

Intervention

Procedure:
• Extended endoscopic sinus surgery
ESS of all sinuses
• Limited endoscopic sinus surgery
Partial ethmoidectomy

Locations

Country	Name	City	State
Finland	Department of Otorhinolaryngology, Helsinki University Hospital	Helsinki
Finland	Kuopio University Hospital	Kuopio
Netherlands	Academic Medical Center	Amsterdam

Sponsors (1)

Lead Sponsor	Collaborator
Helsinki University Central Hospital

Countries where clinical trial is conducted

Finland,  Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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