Aggravated Airway Inflammation: Research on Genomics and Optimal Medical Care (AirGOs-medical)
NCT ID: NCT03825757
Last Updated: 2024-12-27
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
40 participants
INTERVENTIONAL
2019-01-31
2023-06-27
Brief Summary
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Detailed Description
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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
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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Primaspan tablet 250 mg
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.
Acetyl Salicylic Acid
Primaspan 250 mg tablet Acetyl Salicylic Acid
Placebo tablet
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.
Placebo Oral Tablet
Placebo Oral Tablet
Interventions
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Placebo Oral Tablet
Placebo Oral Tablet
Acetyl Salicylic Acid
Primaspan 250 mg tablet Acetyl Salicylic Acid
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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.
Exclusion Criteria
* bleeding diathesis
* pregnancy/ breastfeeding
* cystic fibrosis
* primary ciliary dyskinesia (PCD)
* sarcoidosis
* 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
18 Years
65 Years
ALL
No
Sponsors
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University of Helsinki
OTHER
Sanna Salmi
OTHER
Responsible Party
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Sanna Salmi
Senior Consultant Otorhinolaryngologist, PI
Principal Investigators
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Sanna Toppila-Salmi, MD PhD
Role: PRINCIPAL_INVESTIGATOR
Helsinki University Central Hospital
Locations
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Helsinki University Hospital
Helsinki, , Finland
Countries
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References
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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.
Related Links
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Diagnosis and management of NSAID-Exacerbated Respiratory Disease (N-ERD)-a EAACI position paper.
Aspirin-Exacerbated Respiratory Disease. Publication.
Other Identifiers
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2017-001570-42
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
TYH2018203
Identifier Type: -
Identifier Source: org_study_id