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

Primary Purpose

Sinusitis, Chronic, Asthma, Nasal Polyps

Status
Active
Phase
Not Applicable
Locations
International
Study Type
Interventional
Intervention
Extended endoscopic sinus surgery
Limited endoscopic sinus surgery
Sponsored by
Helsinki University Central Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Sinusitis, Chronic

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Department of Otorhinolaryngology, Helsinki University Hospital
  • Kuopio University Hospital
  • Academic Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Extended

Limited

Arm Description

Extended sinus surgery including all sinuses

Limited sinus surgery with partial ethmoidectomy

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Full Information

First Posted
October 8, 2018
Last Updated
September 25, 2023
Sponsor
Helsinki University Central Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT03704415
Brief Title
Aggravated Airway Inflammation: Research on Genomics and Optimal Operative Treatment (AirGOs Operative)
Official Title
Aggravated Airway Inflammation: Research on Genomics and Optimal Operative Treatment (AirGOs Operative)
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
October 23, 2018 (Actual)
Primary Completion Date
December 31, 2024 (Anticipated)
Study Completion Date
December 31, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Helsinki University Central Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.
Detailed Description
Please see study protocol

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Sinusitis, Chronic, Asthma, Nasal Polyps, Aspirin Sensitivity

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
97 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Extended
Arm Type
Active Comparator
Arm Description
Extended sinus surgery including all sinuses
Arm Title
Limited
Arm Type
Active Comparator
Arm Description
Limited sinus surgery with partial ethmoidectomy
Intervention Type
Procedure
Intervention Name(s)
Extended endoscopic sinus surgery
Intervention Description
ESS of all sinuses
Intervention Type
Procedure
Intervention Name(s)
Limited endoscopic sinus surgery
Intervention Description
Partial ethmoidectomy
Primary Outcome Measure Information:
Title
Sino-nasal outcome test (SNOT-22)
Description
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Paula Virkkula, Docent
Organizational Affiliation
Helsinki University Central Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Department of Otorhinolaryngology, Helsinki University Hospital
City
Helsinki
ZIP/Postal Code
00380
Country
Finland
Facility Name
Kuopio University Hospital
City
Kuopio
Country
Finland
Facility Name
Academic Medical Center
City
Amsterdam
ZIP/Postal Code
1105
Country
Netherlands

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing 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.

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

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