Aggravated Airway Inflammation: Research on Genomics and Optimal Medical Care (AirGOs-medical)

• Status: Recruiting
• Trial end date: 2027-03-31
• Target enrollment: 0
• Participant gender: All

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. 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).

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Sanna Salmi
• Collaborators: Helsinki University; University of Helsinki
• Treatments: Aspirin; Salicylates; Salicylic Acid

Criteria

Inclusion Criteria: ALL these need to be positive:

• 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.

Exclusion Criteria:

• complication of CRS (f.e. mucocele, invasive fungal rhinosinusitis)

• 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