Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03704415
Recruitment Status : Recruiting
First Posted : October 12, 2018
Last Update Posted : March 4, 2020
Sponsor:
Information provided by (Responsible Party):
Paula Virkkula, Helsinki University Central Hospital

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.

Condition or disease Intervention/treatment Phase
Sinusitis, Chronic Asthma Nasal Polyps Aspirin Sensitivity Procedure: Extended endoscopic sinus surgery Procedure: Limited endoscopic sinus surgery Not Applicable

Detailed Description:
Please see study protocol

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 174 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Aggravated Airway Inflammation: Research on Genomics and Optimal Operative Treatment (AirGOs Operative)
Actual Study Start Date : October 23, 2018
Estimated Primary Completion Date : December 2023
Estimated Study Completion Date : December 2023

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




Primary Outcome Measures :
  1. Sino-nasal outcome test (SNOT-22) [ Time Frame: Baseline, Post-intervention every 3 months during 2 years ]
    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.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03704415


Contacts
Layout table for location contacts
Contact: Paula Virkkula, Dosent +358-50-4279143 paula.virkkula@hus.fi

Locations
Layout table for location information
Finland
Department of Otorhinolaryngology, Helsinki University Hospital Recruiting
Helsinki, Finland, 00380
Contact: Paula Virkkula, MD, PhD    +358-504279143    paula.virkkula@hus.fi   
Contact: Sari Hammarén-Malmi, MD, PhD    +358-0-4711    sari.hammaren-malmi@hus.fi   
Principal Investigator: Virkkula         
Sub-Investigator: Hammarén-Malmi         
Sub-Investigator: Laulajainen-Hongisto         
Sub-Investigator: Hafrén         
Sub-Investigator: Kauppi         
Sub-Investigator: Lilja         
Sub-Investigator: Vento         
Sub-Investigator: Wikstén         
Kuopio University Hospital Recruiting
Kuopio, Finland
Contact: Johanna Sahlman, MD, PhD         
Netherlands
Academic Medical Center Not yet recruiting
Amsterdam, Netherlands, 1105
Contact: Sietze Reitsma, MD    +31642135872    s.reitsma@amsterdamumc.nl   
Contact: Wytske Fokkens, MD, PhD    +31634150093    w.j.fokkens@amsterdamumc.nl   
Sponsors and Collaborators
Helsinki University Central Hospital
Investigators
Layout table for investigator information
Principal Investigator: Paula Virkkula, Docent Helsinki University Central Hospital
  Study Documents (Full-Text)

Documents provided by Paula Virkkula, Helsinki University Central Hospital:

Layout table for additonal information
Responsible Party: Paula Virkkula, Chief Physician in Rhinology, Helsinki University Central Hospital
ClinicalTrials.gov Identifier: NCT03704415    
Other Study ID Numbers: AirGOs Operative
First Posted: October 12, 2018    Key Record Dates
Last Update Posted: March 4, 2020
Last Verified: March 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Individual participant data that underlie the results reported in this article, after deidentification (text, tables, figures and appendices) can be shared.
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Time Frame: Beginning 3 months and ending 3 years after article publication.
Access Criteria: Researchers who provide a methodologically sound proposal.

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
Layout table for MeSH terms
Sinusitis
Nasal Polyps
Inflammation
Pathologic Processes
Paranasal Sinus Diseases
Nose Diseases
Respiratory Tract Diseases
Respiratory Tract Infections
Otorhinolaryngologic Diseases
Polyps
Pathological Conditions, Anatomical