Status:
COMPLETED
Aggravated Airway Inflammation: Research on Genomics and Optimal Medical Care (AirGOs-medical)
Lead Sponsor:
Sanna Salmi
Collaborating Sponsors:
University of Helsinki
Conditions:
Chronic Rhinosinusitis (Diagnosis)
Eligibility:
All Genders
18-65 years
Phase:
NA
Brief 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 ...
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=1...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
January 31 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 27 2023
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT03825757
Start Date
January 31 2019
End Date
June 27 2023
Last Update
December 27 2024
Active Locations (1)
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1
Helsinki University Hospital
Helsinki, Finland, 00029