Asthma, Aspirin-InducedPhase 4AirGOs-biolNCT04823585
Aggravated Airway Inflammation: Research on Biological Treatment (Mepolizumab)
A Phase 4 study testing Mepolizumab in people with Asthma, Aspirin-Induced and Chronic Rhinosinusitis With Nasal Polyps, run by Helsinki University Central Hospital at 1 site in Finland.
Trial summary
Primary objective: to investigate the efficacy of Mepolizumab 100 milligram (mg) every month compared to placebo in reducing validated Sinonasal Outcome Test -22 score and on reducing endoscopic Nasal Polyp Score. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Asthma, Aspirin-Induced, Chronic Rhinosinusitis With Nasal Polyps
- What is being tested?
- Mepolizumab
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 95 participants
- Where
- 1 siteFinland
- Study dates
- 12 Aug 2021to 16 Jan 2025
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- ≥18 years of age
- Exacerbation of respiratory symptoms by acetylsalicylic acid (ASA) or another NSAID. (NERD will be verified by another visit if necessary).
- chronic rhinosinusitis with bilateral polyps. Endoscopic bilateral nasal polyp score of at least 5 (out of 8), with a minimum score of 2 in each nasal cavity
- Lund Mackay score ≥12 (maximum 24) of sinus computed tomography (CT) or cone beam (CBCT) scans. The new sinus CT/CBCT scans are needed if the previous sinus CT/CBCT scans have been performed over 36 months before recruitment visit or if there is a suspicion of complication of CRS (f.ex. mucocele, invasive fungal rhinosinusitis). Pregnant and breast-feeding subject will be excluded. Females of Reproductive Potential (FRPs) who are not pregnant or breast-feeding may be enrolled. FRPs need to perform pregnancy test prior to the CT/CBCT scans. If subject is already on contraception prior to the study this should be continued. The data of previous sinus CT/CBCT scans will be used if previous sinus CT/CBCT scans have been performed ≤36 months prior to recruitment visit. The clinical information of sinus CT/CBCT scans is critical to enrolling appropriate subjects for the research and cannot readily be obtained another way. The radiation dose of sinus CT/CBCT scans is less than 0.1 mSv, which corresponds to less than 10 days of natural background radiation in Finland. This dose has not been shown to increase the cancer risk.
- ≥1 previous CRS-surgery. Note that the last CRS-surgery must have been performed at least 6 months before 1st visit
- SNOT-22 ≥25
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- At least one other symptom, such as partial loss of smell (hyposmia), nasal obstruction, total loss of smell (anosmia), or anterior or posterior rhinorrhea
- patient should have a history of at least one exacerbation during the past two years e.g. at least one criterion must be fulfilled of the following list during the past two years ≥1 oral corticosteroids; ≥3 antibiotic courses; ≥1 CRS-operation; ≥ 1 asthma hospitalization. In patients with contraindications of previously listed treatment or continuous oral steroids, additional criteria are not required.
- Asthma diagnosis (patient has the National Social Insurance Institution´s reimbursement right for asthma medication)
- Peripheral blood eosinophils (PBEos) >300 cells/ul at visit 1 OR (PBEos >150 cells/ul at visit 1 AND a history of PBEos >300 cells/ul during the past 12 months). A history of Nasal polyp tissue eosinophilia (NPeos) ≥30% during the past 12 months is a supportive criterion.
Who cannot join
- Age <18 years
- Age > 70 years
- CRS-surgery < 6 months before 1st visit
- pregnancy/ breastfeeding. FRPs need to perform pregnancy test prior to the CT/CBCT scans. If subject is already on contraception prior to the study this should be continued.
- complication of CRS (f.ex. mucocele, invasive fungal rhinosinusitis). Take sinus CT/CBCT scans, if needed!
- acute rhinosinusitis/respiratory infection
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- severe disease related to airways/ immunology: cystic fibrosis, primary ciliary dyskinesia (PCD), sarcoidosis, immunosuppression, diagnosed Specific antibody deficiency (SAD), CVI, HIV, fungal rhinosinusitis; Young syndrome; Kartagener syndrome;
- other severe disease such as active cancer
- Received biologic therapy/systemic immunosuppressant/ASA desensitization therapy/experimental monoclonal antibody treatment to treat inflammatory or autoimmune disease within 2 months of study entry or 5 half-lives, whichever is longer. The patient is allowed to use ASA dose <100 mg/day due to cardiovascular reasons after ASA desensitization.
- current immunotherapy
- communication problems (f.ge. neurological/psychiatric disease, language skills)
- unlikely to comply
- ASA-challenge negative.
- History of hypersensitivity to mepolizumab or excipients in the formulation
Trial locations and contacts
1 site in 1 country.
About this study
Primary objective:
to investigate the efficacy of Mepolizumab 100 milligram (mg) every month compared to placebo in reducing validated Sinonasal Outcome Test -22 score and on reducing endoscopic Nasal Polyp Score. The participants have a triad of chronic rhinosinusitis with nasal polyps (CRSwNP), asthma and non-steroidal anti-inflammatory drug exacerbated respiratory disease (NERD). The investigators will evaluate whether mepolizumab reduces the need for increased drug dosage (topical corticosteroid or bronchodilator dosage) and improves lung and nasal function more effectively than placebo.
This first visit ensures the inclusion and exclusion criteria of the subject. If necessary, NERD will be verified by an ASA challenge test at a second additional visit. Participants have also 6 visits, on four of which subcutaneous injection of the study product is administered. During visits, a clinical examination, airway function tests, and nasal, blood, urine, and stool samples are also taken to elucidate predictive biomarkers of severely symptomatic NERD patients.
Read the detailed description
Primary objective:
to investigate the efficacy of Mepolizumab 100 milligram (mg) every month compared to placebo in reducing validated Sinonasal Outcome Test -22 score and on reducing endoscopic Nasal Polyp Score. The participants have a triad of chronic rhinosinusitis with nasal polyps (CRSwNP), asthma and non-steroidal anti-inflammatory drug exacerbated respiratory disease (NERD). The investigators will evaluate whether mepolizumab reduces the need for increased drug dosage (topical corticosteroid or bronchodilator dosage) and improves lung and nasal function more effectively than placebo.
This first visit ensures the inclusion and exclusion criteria of the subject. If necessary, NERD will be verified by an ASA challenge test at a second additional visit. Participants have also 6 visits, on four of which subcutaneous injection of the study product is administered. During visits, a clinical examination, airway function tests, and nasal, blood, urine, and stool samples are also taken to elucidate predictive biomarkers of severely symptomatic NERD patients.
- Being tested
- Mepolizumab, Placebo
- Medical subject headings
- Asthma, Aspirin-Induced
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MepolizumabDrug
Solution. Subcutaneous. Mepolizumab is a biological drug, a humanized monoclonal antibody against interleukin-5.
PlaceboDrug
Solution. Subcutaneous.
| Study group | Role | What they receive |
|---|---|---|
| subcutaneous injections of placebo | Placebo comparator | Subcutaneous injections of placebo (physiological sodium chloride solution) once per month for 16 weeks. A total of 4 injections. Receives: Drug: Placebo |
| subcutaneous injections of Mepolizumab 100 mg | Experimental | Subcutaneous injections of Mepolizumab 100 mg once per month for 16 weeks. A total of 4 injections. Receives: Drug: Mepolizumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change From Baseline at Week 16 in Sinonasal Outcome Test -22 (SNOT-22) Score
SNOT-22 is a validated symptom questionnaire. The score ranges between 0 and 110. A higher score means worse outcome.
Measured: Baseline, Week 16
Change From Baseline at Week 16 in Endoscopic Nasal Polyp Score of Nasal Cavity
The nasal polyp score (NPS) is assessed bilaterally. Each nasal cavity is graded separately according to polyp size on a scale from 0 (no polyps) to 4 (large polyps causing complete obstruction of the inferior nasal cavity). The total nasal polyp score ranges from 0 to 8 points.
Measured: Baseline, Week 16
Secondary outcomes (2)
Change From Baseline at Week 16 in Asthma Control Test Score
The Asthma Control Test (ACT) is a validated, patient-reported questionnaire used to assess asthma control. Minimum score: 5 points. Maximum score: 25 points. 20-25 points: Well-controlled asthma. ≤15 points: Poorly controlled asthma.
Measured: Baseline, Week 16
Change in FEV1%
Percentage of observed Forced expiratory volume in 1 second (FEV1) of predicted FEV1
Measured: at 16 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Apr 2021
- Study start12 Aug 2021
- Primary completion16 Jan 2025
- Study completion16 Jan 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Asthma, Aspirin-InducedStudies 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 95 participants (actual)
Sponsor and investigators
- Lead sponsor
- Helsinki University Central Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sanna Salmi, Helsinki University Central Hospital
- Investigators
- Sanna Toppila-Salmi, MD PhD, PI, Principal investigator, Helsinki University Hospital, Skin and Allergy Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04823585
- Sponsor's protocol ID
- HUS/686/2020
- Acronym
- AirGOs-biol
- Status last verified
- Mar 2026
- First submitted
- 25 Mar 2021
- Last updated
- 24 Mar 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Due to Finnish data protection legislation, confidential, health-related data, the datasets produced and/or examined during this study are not accessible to the general public. They can solely be managed by designated individuals within the study group for specific research objectives. The datasets analyzed during the current study are available from the corresponding author upon reasonable request. Data use permissions can be applied from the competent authorities.
Publications
Lyly A, Sahlman J, Pajala K, Salminen M, Sillanpaa S, Numminen J, Hanif T, Laulajainen-Hongisto A, Makela M, Kauppi P, Kangasniemi I, Lilja M, Hammaren-Malmi S, Virkkula P, Toppila-Salmi S. Study protocol for a randomized double-blinded placebo-controlled trial on mepolizumab for patients with chronic rhinosinusitis with nasal polyps, NSAID exacerbated respiratory disease and asthma. Front Allergy. 2025 Mar 21;6:1568081. doi: 10.3389/falgy.2025.1568081. eCollection 2025.
PubMed 40191526
Study at a glance
From the registry record, last updated by the sponsor on 24 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Aggravated Airway Inflammation: Research on Biological Treatment (Mepolizumab)
- ClinicalTrials.gov ID
- NCT04823585
- Acronym / sponsor ID
- AirGOs-biol / HUS/686/2020
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 95 participants (actual)
- Lead sponsor
- Helsinki University Central HospitalUniversity, hospital or other
- Study start
- 12 Aug 2021 (actual)
- Primary completion
- 16 Jan 2025 (actual)
- Study completion
- 16 Jan 2025 (actual)
- First posted
- 1 Apr 2021 (actual)
- Results
- Posted 24 Mar 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Primary objective:
to investigate the efficacy of Mepolizumab 100 milligram (mg) every month compared to placebo in reducing validated Sinonasal Outcome Test -22 score and on reducing endoscopic Nasal Polyp Score. The participants have a triad of chronic rhinosinusitis with nasal polyps (CRSwNP), asthma and non-steroidal anti-inflammatory drug exacerbated respiratory disease (NERD). The investigators will evaluate whether mepolizumab reduces the need for increased drug dosage (topical corticosteroid or bronchodilator dosage) and improves lung and nasal function more effectively than placebo.
This first visit ensures the inclusion and exclusion criteria of the subject. If necessary, NERD will be verified by an ASA challenge test at a second additional visit. Participants have also 6 visits, on four of which subcutaneous injection of the study product is administered. During visits, a clinical examination, airway function tests, and nasal, blood, urine, and stool samples are also taken to elucidate predictive biomarkers of severely symptomatic NERD patients.
Detailed description
Primary objective:
to investigate the efficacy of Mepolizumab 100 milligram (mg) every month compared to placebo in reducing validated Sinonasal Outcome Test -22 score and on reducing endoscopic Nasal Polyp Score. The participants have a triad of chronic rhinosinusitis with nasal polyps (CRSwNP), asthma and non-steroidal anti-inflammatory drug exacerbated respiratory disease (NERD). The investigators will evaluate whether mepolizumab reduces the need for increased drug dosage (topical corticosteroid or bronchodilator dosage) and improves lung and nasal function more effectively than placebo.
This first visit ensures the inclusion and exclusion criteria of the subject. If necessary, NERD will be verified by an ASA challenge test at a second additional visit. Participants have also 6 visits, on four of which subcutaneous injection of the study product is administered. During visits, a clinical examination, airway function tests, and nasal, blood, urine, and stool samples are also taken to elucidate predictive biomarkers of severely symptomatic NERD patients.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| subcutaneous injections of placebo | Placebo comparator | Drug: PlaceboSubcutaneous injections of placebo (physiological sodium chloride solution) once per month for 16 weeks. A total of 4 injections. |
| subcutaneous injections of Mepolizumab 100 mg | Experimental | Drug: MepolizumabSubcutaneous injections of Mepolizumab 100 mg once per month for 16 weeks. A total of 4 injections. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- ≥18 years of age
- Exacerbation of respiratory symptoms by acetylsalicylic acid (ASA) or another NSAID. (NERD will be verified by another visit if necessary).
- chronic rhinosinusitis with bilateral polyps. Endoscopic bilateral nasal polyp score of at least 5 (out of 8), with a minimum score of 2 in each nasal cavity
- Lund Mackay score ≥12 (maximum 24) of sinus computed tomography (CT) or cone beam (CBCT) scans. The new sinus CT/CBCT scans are needed if the previous sinus CT/CBCT scans have been performed over 36 months before recruitment visit or if there is a suspicion of complication of CRS (f.ex. mucocele, invasive fungal rhinosinusitis). Pregnant and breast-feeding subject will be excluded. Females of Reproductive Potential (FRPs) who are not pregnant or breast-feeding may be enrolled. FRPs need to perform pregnancy test prior to the CT/CBCT scans. If subject is already on contraception prior to the study this should be continued. The data of previous sinus CT/CBCT scans will be used if previous sinus CT/CBCT scans have been performed ≤36 months prior to recruitment visit. The clinical information of sinus CT/CBCT scans is critical to enrolling appropriate subjects for the research and cannot readily be obtained another way. The radiation dose of sinus CT/CBCT scans is less than 0.1 mSv, which corresponds to less than 10 days of natural background radiation in Finland. This dose has not been shown to increase the cancer risk.
- ≥1 previous CRS-surgery. Note that the last CRS-surgery must have been performed at least 6 months before 1st visit
Key exclusion criteria (14 listed)
- Age <18 years
- Age > 70 years
- CRS-surgery < 6 months before 1st visit
- pregnancy/ breastfeeding. FRPs need to perform pregnancy test prior to the CT/CBCT scans. If subject is already on contraception prior to the study this should be continued.
- complication of CRS (f.ex. mucocele, invasive fungal rhinosinusitis). Take sinus CT/CBCT scans, if needed!
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 |
|---|---|---|
| MepolizumabSolution. Subcutaneous. Mepolizumab is a biological drug, a humanized monoclonal antibody against interleukin-5. | Drug | subcutaneous injections of Mepolizumab 100 mg |
| PlaceboSolution. Subcutaneous. | Drug | subcutaneous injections of placebo |
Primary outcome
Change From Baseline at Week 16 in Sinonasal Outcome Test -22 (SNOT-22) Score
Time frame: Baseline, Week 16
SNOT-22 is a validated symptom questionnaire. The score ranges between 0 and 110. A higher score means worse outcome.
Change From Baseline at Week 16 in Endoscopic Nasal Polyp Score of Nasal Cavity
Time frame: Baseline, Week 16
The nasal polyp score (NPS) is assessed bilaterally. Each nasal cavity is graded separately according to polyp size on a scale from 0 (no polyps) to 4 (large polyps causing complete obstruction of the inferior nasal cavity). The total nasal polyp score ranges from 0 to 8 points.
2 secondary outcomes
Change From Baseline at Week 16 in Asthma Control Test Score
Time frame: Baseline, Week 16
Change in FEV1%
Time frame: at 16 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Mar 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 40191526Lyly A, Sahlman J, Pajala K, Salminen M, Sillanpaa S, Numminen J, Hanif T, Laulajainen-Hongisto A, Makela M, Kauppi P, Kangasniemi I, Lilja M, Hammaren-Malmi S, Virkkula P, Toppila-Salmi S. Study protocol for a randomized double-blinded placebo-controlled trial on mepolizumab for patients with chronic rhinosinusitis with nasal polyps, NSAID exacerbated respiratory disease and asthma. Front Allergy. 2025 Mar 21;6:1568081. doi: 10.3389/falgy.2025.1568081. eCollection 2025.
- Individual participant dataSharing planned: No. Due to Finnish data protection legislation, confidential, health-related data, the datasets produced and/or examined during this study are not accessible to the general public. They can solely be managed by designated individuals within the study group for specific research objectives. The datasets analyzed during the current study are available from the corresponding author upon reasonable request. Data use permissions can be applied from the competent authorities.
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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.
Sanna Toppila-Salmi, MD PhD, PI principal investigator
Helsinki University Hospital, Skin and Allergy Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Mepolizumab in people with Asthma, Aspirin-Induced and Chronic Rhinosinusitis With Nasal Polyps, run by Helsinki University Central Hospital at 1 site in Finland.
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 10 inclusion and 14 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 24 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Finland. 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 24 Mar 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Change From Baseline at Week 16 in Sinonasal Outcome Test -22 (SNOT-22) Score (time frame: Baseline, Week 16). The study lists 2 primary outcomes in all. 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 NCT04823585, 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 24 Mar 2026.