NCT03704415Completed
Aggravated Airway Inflammation: Research on Genomics and Optimal Operative Treatment (AirGOs Operative)
Source: ClinicalTrials.gov · Last updated 18 Mar 2025
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Study type
- Interventional
- Enrollment
- 97 (actual)
- First submitted
- 8 Oct 2018
- Start date
- 23 Oct 2018
- Primary completion date
- 23 Oct 2024
- Lead sponsor
- Helsinki University Central Hospital
- Diseases
- Asthma
- NCT number
- NCT03704415
What you commit to
- Study type: Interventional
- Participants enrolled: 97
- From 23 Oct 2018 to the primary completion date, 23 Oct 2024
- 3 sites in 2 countries
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Previous external sinus surgery or Draf 3 procedure (or indication for external approaches or Draf 3
- Immunotherapy
- Daily use of systemic corticosteroids
Other illness
- Bleeding diathesis
- Immunosupression (diagnosed Spesific Antibody Deficiency (SAD), common variable immunodeficiency (CVI), HIV or use of biologicals/immunosuppressive medication)
- Communication problems (f.e. neurological/psychiatric disease, language skills)
- Other severe disease
Age
- Age \<18 years, age \> 65 years
Other
- Complication of CRS (f.e. mucocele, invasive fungal rhinosinusitis)
- Other diagnosis than CRSwNP (inverted papilloma, antrochoanal polyp etc.)
- Pregnancy/ breastfeeding
- Cystic fibrosis
- Primary ciliary dyskinesia (PCD)
- Sarcoidosis
- Granulomatosis with polyangitis (GPA)
- Eosinophilic granulomatosis with polyangitis (EGPA)
- Unlikely to comply
- Inability to be operated.
Who the study is looking for
- 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
Age in the registry: 18 years to 65 years · Sex: All · Does not accept healthy volunteers
Sites (3)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Department of Otorhinolaryngology, Helsinki University Hospital Coordinator of this site? Confirm its status | Helsinki | Finland | Unknown status |
| Kuopio University Hospital Coordinator of this site? Confirm its status | Kuopio | Finland | Unknown status |
| Academic Medical Center Coordinator of this site? Confirm its status | Amsterdam | Netherlands | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.