Chronic Rhinosinusitis (Diagnosis)AirGOs-medNCT03825757
Aggravated Airway Inflammation: Research on Genomics and Optimal Medical Care (AirGOs-medical)
A study testing Acetyl Salicylic Acid in people with Chronic Rhinosinusitis (Diagnosis), run by Sanna Salmi at 1 site in Finland.
Trial summary
The study is performed as a randomized double-blinded prospective controlled trial. A total of 72 adult Acetyl salicylic acid (ASA) -exacerbated respiratory disease (AERD) -patients with uncontrolled chronic rhinosinusitis with nasal polyps (CRSwNP) will be recruited. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Chronic Rhinosinusitis (Diagnosis)
- What is being tested?
- Acetyl Salicylic Acid
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- 1 siteFinland
- Study dates
- 31 Jan 2019to 27 Jun 2023
- 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
- Endoscopic nasal polyp score ≥4
- SNOT-22 ≥30
- Sinus Computed tomography Lund-Mackay score ≥14. The new sinus CT scans are needed if the previous sinus CT 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)
- ≥1 previous partial/total ethmoidectomy surgery.
- In addition, patient should have a history of at least one of the following:
- >1 oral corticosteroids during the past two years >3 antibiotic courses during the past two years. In patients with contraindication/adverse effects in using oral steroids additional criteria are not required.
Who cannot join
- complication of CRS (f.e. mucocele, invasive fungal rhinosinusitis)
- bleeding diathesis
- pregnancy/ breastfeeding
- cystic fibrosis
- primary ciliary dyskinesia (PCD)
- sarcoidosis
Show all 21Show fewer
- granulomatosis with polyangitis (GPA)
- eosinophilic granulomatosis with polyangitis (EGPA)
- immunosuppression (diagnosed Spesific antibody deficiency (SAD), CVI, HIV
- use of biologicals/immunosuppressive medication
- immunotherapy
- Daily use of systemic corticosteroids (Prednisolon 10mg or equivalent) -communication problems (f.e. neurological/psychiatric disease, language skills) -unlikely to comply
- other severe disease
- uncontrolled asthma
- ASA-challenge negative
- gastric ulcer
- anticoagulant treatment
- SSRI-depression medication
- beta-blocker
- severe chronic urticaria
- ASA anaphylaxis
Trial locations and contacts
1 site in 1 country.
About this study
The study is performed as a randomized double-blinded prospective controlled trial. A total of 72 adult Acetyl salicylic acid (ASA) -exacerbated respiratory disease (AERD) -patients with uncontrolled chronic rhinosinusitis with nasal polyps (CRSwNP) will be recruited. Those negative to ASA-challenge test will not enter the Clinical Trial . All patients entering the Clinical Trial, have undergone earlier ethmoidal surgery (partial/total) and have not gained disease control. F-helicobacter antigen is tested and treatment is given if indicated. The patients are recruited at the Helsinki University Hospital (HUH). The study will be monitored by a professional monitor. Electronic CRF and paper/electronic patient questionnaires provided by HUS will be used (eCRF and patient questionnairea, Granitics).
Read the detailed description
Randomization and the treatment arms I-II: The patients are randomized to two treatment arms I) ASA- desensitization po tablet daily for 11 months (n=36) II) Placebo po tablet daily for 11 months (n=18).
ASA challenge and desensitization (Primaspan) /Placebo: is conducted according to modified international protocol. FEV1 should be at least 1.5 L and > 60% of predicted before challenge or desensitization. On the first day every patient will receive 25 mg + 25 mg ASA at a hospital setting. On the second day every patient will receive 50 mg + 25 mg ASA at a hospital setting. On the third day every patient will receive 75 mg + 25 mg ASA at a hospital setting. On the fourth day every patient will receive 100 mg + 25 mg ASA at a hospital setting.
During the ASA challenge, patient who is ASA-challenge positive is then randomized and starts the trial so that he/she uses blinded ½ tablet of 250 mg ASA or ½ tablet of placebo daily at home for the next 1 month. After this period of 1 month, the dosing is increased at hospital setting, so that the patient receives blindly 250 mg ASA 1/2 tablet + 1/2 tablet or placebo 1/2 tablet + 1/2 tablet. Thereafter he/she will continue using blindly 250 mg ASA 1 tablet or placebo 1 tablet daily at home for the next 10 months. If the patient does not tolerate the up-dosing of ASA/placebo, he/she will continue using blindly ½ tablet of 250 mg ASA/placebo daily at home for the next 10 months. The total duration of the ASA/placebo treatment is 11 months. We additionally take nasal, blood and urine samples during the trial.
Follow-ups. The symptom questionnaire and interview of side-effects are performed during each visit. Lung function (eNO, nNO, PEF, spirometry) is monitored and the patient will visit doctor and/or nurse at 1, 5, 11, and 12 months post-starting with the treatment. Samples are taken during recruitment visit, before and after ASA-challenge and at 5, 11 and 12 months post-starting with the treatment. We also monitor side-effects, exacerbations, need of medication (po. cortisocteroids; antibiotics) and satisfaction to treatment.
Primary end point is change in nasal endoscopic nasal polyp score at -4 days vs. +11 months post-randomization. Secondary end point is change in Sinonasal Outcome Test -22 (SNOT-22) score at -4 days vs. +11 months post-randomization, and change in relative Forced expiratory volume in 1 second (FEV1 %) without bronchodilator at -1 month vs. +11 months post-randomization.
Safety (complications, adverse effects), costs and loss of productivity between study arms will be compared.
Trial medication will be discontinued, if surgery is needed before the end of follow-up.
- Conditions
- Chronic Rhinosinusitis (Diagnosis)
- Being tested
- Placebo Oral Tablet, Acetyl Salicylic Acid
- Keywords
- chronic rhinosinusitis with nasal polyps, Acetyl salicylic acid exacerbated respiratory disease
- Medical subject headings
- Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Placebo Oral TabletDrug
Also called Placebo
Placebo Oral Tablet
Acetyl Salicylic AcidDrug
Also called Primaspan 250 mg tablet
Primaspan 250 mg tablet Acetyl Salicylic Acid
| Study group | Role | What they receive |
|---|---|---|
| Primaspan tablet 250 mg | Experimental | Primaspan tablet 250 mg (Acetyl salicylic acid): 1/2 tablet once daily during 1 month. 1 tablet once daily during 10 months. If not tolerated the dose 1 tablet x1/day, the patient is allowed to continue with the dose of 1/2 tablet x1/day. Receives: Drug: Acetyl Salicylic Acid |
| Placebo tablet | Placebo comparator | Placebo Oral Tablet: 1/2 tablet once daily during 1 month. 1 tablet once daily during 10 months. If not tolerated the dose 1 tablet x1/day, the patient is allowed to continue with the dose of 1/2 tablet x1/day. Receives: Drug: Placebo Oral Tablet |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in endoscopic Nasal polyp score of both sides of the nasal cavity.
Change means differences between at time -4 days versus (vs.) at time +11 months post-randomization. Minimum value is 0. Maximum value is 8. A higher score means worse outcome.
Measured: at -4 days vs. at 11 months post-randomization
Secondary outcomes (2)
Change in Sinonasal outcome test 22 (SNOT22). Validated nose-specific quality of life questionnaire, 0-110 points.
Change means differences between at time -4 days vs. +11 months post-randomization. A higher score means worse outcome.
Measured: at -4 days vs. at 11 months post-randomization
Change in the Relative forced expiratory volume in 1 second (FEV1%) without bronchodilator.
Change means differences between at time -1 month vs. +11 months post-randomization. A higher value means better outcome. FEV1% is measured by Spirometry.
Measured: at -1 month vs. at 11 months post-randomization
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jan 2019
- Study start31 Jan 2019
- Primary completion27 Jun 2023
- Study completion27 Jun 2023
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 Chronic Rhinosinusitis (Diagnosis)Studies of the same condition, open and under way.
- 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
- Model description
- Randomized double-blinded controlled trial
- Masking
- Single blind
- Who is masked
- Care provider
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sanna Salmi
- Sponsor type
- University, hospital or other
- Collaborators
- University of Helsinki
- Responsible party
- Sponsor-investigator, Sanna Salmi, Helsinki University Central Hospital
- Investigators
- Sanna Toppila-Salmi, MD PhD, Principal investigator, Helsinki University Central Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03825757
- Sponsor's protocol ID
- TYH2018203
- Other IDs
- 2017-001570-42, 2017
- Acronym
- AirGOs-med
- Status last verified
- Dec 2024
- First submitted
- 26 Jan 2019
- Last updated
- 27 Dec 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: The data is owned by Helsinki University Hospital and University of Helsinki.
Publications
Toppila-Salmi S, Lyly A, Salmi V, Nuutinen M, Kilpio M, Hanif T, Niemi M, Laulajainen-Hongisto A, Hafren L, Makela M, Kauppi P, Virkkula P, Heleva A. Study protocol for a randomized double-blinded placebo-controlled trial on ASA therapy for patients with chronic rhinosinusitis with nasal polyps, NSAID-exacerbated respiratory disease, and asthma. Front Allergy. 2025 May 20;6:1542481. doi: 10.3389/falgy.2025.1542481. eCollection 2025.
PubMed 40463360
Study at a glance
From the registry record, last updated by the sponsor on 27 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Aggravated Airway Inflammation: Research on Genomics and Optimal Medical Care (AirGOs-medical)
- ClinicalTrials.gov ID
- NCT03825757
- Acronym / sponsor ID
- AirGOs-med / TYH2018203
- Conditions
- Chronic Rhinosinusitis (Diagnosis)
- Keywords
- chronic rhinosinusitis with nasal polyps, Acetyl salicylic acid exacerbated respiratory disease
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Sanna SalmiUniversity, hospital or other
- Collaborators
- University of Helsinki
- Study start
- 31 Jan 2019 (actual)
- Primary completion
- 27 Jun 2023 (actual)
- Study completion
- 27 Jun 2023 (actual)
- First posted
- 31 Jan 2019 (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.
The study is performed as a randomized double-blinded prospective controlled trial. A total of 72 adult Acetyl salicylic acid (ASA) -exacerbated respiratory disease (AERD) -patients with uncontrolled chronic rhinosinusitis with nasal polyps (CRSwNP) will be recruited. Those negative to ASA-challenge test will not enter the Clinical Trial . All patients entering the Clinical Trial, have undergone earlier ethmoidal surgery (partial/total) and have not gained disease control. F-helicobacter antigen is tested and treatment is given if indicated. The patients are recruited at the Helsinki University Hospital (HUH). The study will be monitored by a professional monitor. Electronic CRF and paper/electronic patient questionnaires provided by HUS will be used (eCRF and patient questionnairea, Granitics).
Detailed description
Randomization and the treatment arms I-II: The patients are randomized to two treatment arms I) ASA- desensitization po tablet daily for 11 months (n=36) II) Placebo po tablet daily for 11 months (n=18).
ASA challenge and desensitization (Primaspan) /Placebo: is conducted according to modified international protocol. FEV1 should be at least 1.5 L and > 60% of predicted before challenge or desensitization. On the first day every patient will receive 25 mg + 25 mg ASA at a hospital setting. On the second day every patient will receive 50 mg + 25 mg ASA at a hospital setting. On the third day every patient will receive 75 mg + 25 mg ASA at a hospital setting. On the fourth day every patient will receive 100 mg + 25 mg ASA at a hospital setting.
During the ASA challenge, patient who is ASA-challenge positive is then randomized and starts the trial so that he/she uses blinded ½ tablet of 250 mg ASA or ½ tablet of placebo daily at home for the next 1 month. After this period of 1 month, the dosing is increased at hospital setting, so that the patient receives blindly 250 mg ASA 1/2 tablet + 1/2 tablet or placebo 1/2 tablet + 1/2 tablet. Thereafter he/she will continue using blindly 250 mg ASA 1 tablet or placebo 1 tablet daily at home for the next 10 months. If the patient does not tolerate the up-dosing of ASA/placebo, he/she will continue using blindly ½ tablet of 250 mg ASA/placebo daily at home for the next 10 months. The total duration of the ASA/placebo treatment is 11 months. We additionally take nasal, blood and urine samples during the trial.
Follow-ups. The symptom questionnaire and interview of side-effects are performed during each visit. Lung function (eNO, nNO, PEF, spirometry) is monitored and the patient will visit doctor and/or nurse at 1, 5, 11, and 12 months post-starting with the treatment. Samples are taken during recruitment visit, before and after ASA-challenge and at 5, 11 and 12 months post-starting with the treatment. We also monitor side-effects, exacerbations, need of medication (po. cortisocteroids; antibiotics) and satisfaction to treatment.
Primary end point is change in nasal endoscopic nasal polyp score at -4 days vs. +11 months post-randomization. Secondary end point is change in Sinonasal Outcome Test -22 (SNOT-22) score at -4 days vs. +11 months post-randomization, and change in relative Forced expiratory volume in 1 second (FEV1 %) without bronchodilator at -1 month vs. +11 months post-randomization.
Safety (complications, adverse effects), costs and loss of productivity between study arms will be compared.
Trial medication will be discontinued, if surgery is needed before the end of follow-up.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (care provider)
- Number of arms
- 2
- Model description
- Randomized double-blinded controlled trial
| Arm | Type | Receives |
|---|---|---|
| Primaspan tablet 250 mg | Experimental | Drug: Acetyl Salicylic AcidPrimaspan tablet 250 mg (Acetyl salicylic acid): 1/2 tablet once daily during 1 month. 1 tablet once daily during 10 months. If not tolerated the dose 1 tablet x1/day, the patient is allowed to continue with the dose of 1/2 tablet x1/day. |
| Placebo tablet | Placebo comparator | Drug: Placebo Oral TabletPlacebo Oral Tablet: 1/2 tablet once daily during 1 month. 1 tablet once daily during 10 months. If not tolerated the dose 1 tablet x1/day, the patient is allowed to continue with the dose of 1/2 tablet x1/day. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Endoscopic nasal polyp score ≥4
- SNOT-22 ≥30
- Sinus Computed tomography Lund-Mackay score ≥14. The new sinus CT scans are needed if the previous sinus CT 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)
- ≥1 previous partial/total ethmoidectomy surgery.
- >1 oral corticosteroids during the past two years >3 antibiotic courses during the past two years. In patients with contraindication/adverse effects in using oral steroids additional criteria are not required.
Key exclusion criteria (21 listed)
- complication of CRS (f.e. mucocele, invasive fungal rhinosinusitis)
- bleeding diathesis
- pregnancy/ breastfeeding
- cystic fibrosis
- primary ciliary dyskinesia (PCD)
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 |
|---|---|---|
| Placebo Oral TabletAlso: PlaceboPlacebo Oral Tablet | Drug | Placebo tablet |
| Acetyl Salicylic AcidAlso: Primaspan 250 mg tabletPrimaspan 250 mg tablet Acetyl Salicylic Acid | Drug | Primaspan tablet 250 mg |
Primary outcome
Change in endoscopic Nasal polyp score of both sides of the nasal cavity.
Time frame: at -4 days vs. at 11 months post-randomization
Change means differences between at time -4 days versus (vs.) at time +11 months post-randomization. Minimum value is 0. Maximum value is 8. A higher score means worse outcome.
2 secondary outcomes
Change in Sinonasal outcome test 22 (SNOT22). Validated nose-specific quality of life questionnaire, 0-110 points.
Time frame: at -4 days vs. at 11 months post-randomization
Change in the Relative forced expiratory volume in 1 second (FEV1%) without bronchodilator.
Time frame: at -1 month vs. at 11 months post-randomization
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 27 Dec 2024.
- Derived from this study: PubMed 40463360Toppila-Salmi S, Lyly A, Salmi V, Nuutinen M, Kilpio M, Hanif T, Niemi M, Laulajainen-Hongisto A, Hafren L, Makela M, Kauppi P, Virkkula P, Heleva A. Study protocol for a randomized double-blinded placebo-controlled trial on ASA therapy for patients with chronic rhinosinusitis with nasal polyps, NSAID-exacerbated respiratory disease, and asthma. Front Allergy. 2025 May 20;6:1542481. doi: 10.3389/falgy.2025.1542481. eCollection 2025.
- Diagnosis and management of NSAID-Exacerbated Respiratory Disease (N-ERD)-a EAACI position paper.Link provided by the sponsor.
- Aspirin-Exacerbated Respiratory Disease. Publication.Link provided by the sponsor.
- Individual participant dataSharing planned: No. The data is owned by Helsinki University Hospital and University of Helsinki.
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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 principal investigator
Helsinki University Central Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Acetyl Salicylic Acid in people with Chronic Rhinosinusitis (Diagnosis), run by Sanna Salmi 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 6 inclusion and 21 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 27 Dec 2024. 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.
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?
Change in endoscopic Nasal polyp score of both sides of the nasal cavity. (time frame: at -4 days vs. at 11 months post-randomization). 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 NCT03825757, 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 27 Dec 2024.