Sinusitis, ChronicNCT03704415
Aggravated Airway Inflammation: Research on Genomics and Optimal Operative Treatment (AirGOs Operative)
A study testing Extended endoscopic sinus surgery and Limited endoscopic sinus surgery in people with Sinusitis, Chronic and Asthma, run by Helsinki University Central Hospital at 3 sites in 2 countries.
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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Sinusitis, Chronic, Asthma, Nasal Polyps
- What is being tested?
- Extended endoscopic sinus surgery and Limited endoscopic sinus surgery
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 97 participants
- Where
- 3 sitesin 2 countries
- Study dates
- 23 Oct 2018to 23 Oct 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 18Show fewer
- 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.
Trial locations and contacts
3 sites in 2 countries.
3 sites in 2 countries
Finland2 sites
Department of Otorhinolaryngology, Helsinki University Hospital
Helsinki, 00380
Kuopio University Hospital
Kuopio
About this study
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.
Read the detailed description
Please see study protocol
- Conditions
- Sinusitis, Chronic, Asthma, Nasal Polyps, Aspirin Sensitivity
- Being tested
- Extended endoscopic sinus surgery, Limited endoscopic sinus surgery
- Medical subject headings
- Sinusitis, Bronchiolitis Obliterans Syndrome, Asthma, Nasal Polyps
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Extended endoscopic sinus surgeryProcedure or surgery
ESS of all sinuses
Limited endoscopic sinus surgeryProcedure or surgery
Partial ethmoidectomy
| Study group | Role | What they receive |
|---|---|---|
| Extended | Active comparator | Extended sinus surgery including all sinuses Receives: Procedure: Extended endoscopic sinus surgery |
| Limited | Active comparator | Limited sinus surgery with partial ethmoidectomy Receives: Procedure: Limited endoscopic sinus surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline, Post-intervention every 3 months during 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Oct 2018
- Study start23 Oct 2018
- Primary completion23 Oct 2024
- Study completion23 Oct 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Sinusitis, ChronicStudies of the same condition, open and under way.
- More trials run by Helsinki University Central HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 97 participants (actual)
Sponsor and investigators
- Lead sponsor
- Helsinki University Central Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Paula Virkkula, Helsinki University Central Hospital
- Investigators
- Paula Virkkula, Docent, Principal investigator, Helsinki University Central Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03704415
- Sponsor's protocol ID
- AirGOs Operative
- Status last verified
- Mar 2025
- First submitted
- 8 Oct 2018
- Last updated
- 18 Mar 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Individual participant data that underlie the results reported in this article, after deidentification (text, tables, figures and appendices) can be shared.
Publications
Virkkula P, Hammaren-Malmi S, Laulajainen-Hongisto A, Lilja M, Wiksten J, Hafren L, Kauppi P, Reitsma S, Pajala K, Sahlman J, Toppila-Salmi S. Efficacy of Full and Limited Endoscopic Sinus Surgery in Chronic Rhinosinusitis With Nasal Polyps: A Randomised Controlled Trial. Allergy. 2026 Jul 30. doi: 10.1111/all.70438. Online ahead of print.
PubMed 42530386
Study at a glance
From the registry record, last updated by the sponsor on 18 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Aggravated Airway Inflammation: Research on Genomics and Optimal Operative Treatment (AirGOs Operative)
- ClinicalTrials.gov ID
- NCT03704415
- Acronym / sponsor ID
- AirGOs Operative
- Conditions
- Sinusitis, Chronic, Asthma, Nasal Polyps, Aspirin Sensitivity
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 97 participants (actual)
- Lead sponsor
- Helsinki University Central HospitalUniversity, hospital or other
- Study start
- 23 Oct 2018 (actual)
- Primary completion
- 23 Oct 2024 (actual)
- Study completion
- 23 Oct 2024 (actual)
- First posted
- 12 Oct 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Extended | Active comparator | Procedure: Extended endoscopic sinus surgeryExtended sinus surgery including all sinuses |
| Limited | Active comparator | Procedure: Limited endoscopic sinus surgeryLimited sinus surgery with partial ethmoidectomy |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (18 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Extended endoscopic sinus surgeryESS of all sinuses | Procedure or surgery | Extended |
| Limited endoscopic sinus surgeryPartial ethmoidectomy | Procedure or surgery | Limited |
Primary outcome
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Mar 2025.
- Derived from this study: PubMed 42530386Virkkula P, Hammaren-Malmi S, Laulajainen-Hongisto A, Lilja M, Wiksten J, Hafren L, Kauppi P, Reitsma S, Pajala K, Sahlman J, Toppila-Salmi S. Efficacy of Full and Limited Endoscopic Sinus Surgery in Chronic Rhinosinusitis With Nasal Polyps: A Randomised Controlled Trial. Allergy. 2026 Jul 30. doi: 10.1111/all.70438. Online ahead of print.
- Individual participant dataSharing planned: Yes. Individual participant data that underlie the results reported in this article, after deidentification (text, tables, figures and appendices) can be shared.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Paula Virkkula, Docent principal investigator
Helsinki University Central Hospital
3 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Extended endoscopic sinus surgery and Limited endoscopic sinus surgery in people with Sinusitis, Chronic and Asthma, run by Helsinki University Central Hospital at 3 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Finland, Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Sino-nasal outcome test (SNOT-22) (time frame: Baseline, Post-intervention every 3 months during 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03704415, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Mar 2025.