Acetylsalicylic acid (ASA-) exacerbated respiratory disease (AERD).
Conditions
Interventions
Trade Name: Primaspan
Pharmaceutical Form: Tablet
Pharmaceutical form of the placebo: Tablet
Route of administration of the placebo: Oral use
Sponsors
Helsinki University Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: A total of 150 adult AERD patients with uncontrolled CRSwNP will be recruited in the Clinical Trial -part. This is a randomized double-blinded controlled trial with two intervention treatments. About 20% of participants of the Operative part, with uncontrolled AERD, will be recruited to participate the Clinical Trial -part. The patients undergo similar prior examinations as the patients participating The Operative part. Those negative to ASA-challenge test will not enter the Clinical Trial -part. All patients entering the Clinical Trial –part, have undergone earlier ethmoidal surgery (partial/total) and have not gained disease control. F-helicobacter antigen is tested and treatment is given if indicated. Both groups will undergo removal of polyps 4-6 weeks before start of trial medication. Inclusion criteria: Uncontrolled CRS according to EPOS 2012 criteria, endoscopic NP score =4 or SNOT22 = 30, CT LM score total = 12. Polypectomy is scheduled 1-2 months before start of ASA desensitization. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 150 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range 0
Exclusion criteria
Exclusion criteria: Exclusion criteria: Age 65 years, complication of CRS (f.e. mucocele, invasive fungal rhinosinusitis), previous sinus surgery except medial anthrostomy and opening of bulla, bleeding diathesis, pregnancy/ breastfeeding, cystic fibrosis, primary ciliary dyskinesia (PCD), sarcoidosis, granulomatosis with polyangitis (GPA), eosinophilic granulomatosis with polyangitis (EGPA), immunosuppression (diagnosed SAD, CVI, HIV or use of biologicals/immunosuppressive medication), immunotherapy, Daily use of systemic corticosteroids (Prednisolon at least 10mg per day 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 or severe chronic urticaria.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: This is a randomized controlled multicenter study that focuses on severe CRSwNP and asthma in AERD patients. Our specific research questions are: Does ASA desensitization reduce polyp size, symptoms, revision-rate, exacerbation-rate, costs and improve lung function more effectively than placebo? Can we discover clinical or biological markers predictive for the beneficial effect of AD? ;Secondary Objective: Does ASA desensitization reduce polyp size, symptoms, revision-rate, exacerbation-rate, costs and improve lung function more effectively than placebo? ;Primary end point(s): Primary end points are change in nasal endoscopic polyp score, SNOT-22, and lung function tests 11 and 12 months post-starting with the treatment. Secondary end points include changes in hrQOL, acoustic rhinometry (ARM), peak nasal inspiratory flow (PNIF), olfaction test (Sniffin’ Sticks, identification and threshold), pathologic findings, safety and costs. The patient will know the treatment arm at 12 months post-starting with the treatment) and can discuss with the doctor of the need to continue or start with ASA-desensitization or another treatment, if needed.;Timepoint(s) of evaluation of this end point: Primary end points are change in nasal endoscopic polyp score, SNOT-22, and lung function tests 11 and 12 months post-starting with the treatment. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Follow-ups. The visits are before treatment and follow-up visits are once per month at the same time with the injection. 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 before and after challenge and at 11 months post-starting with the treatment. We also monitor side-effects, exacerbations, need of medication (po. cortisocteroids; antibiotics) and satisfaction to treatment. ;Timepoint(s) of evaluation of this end point: Secondary end points include changes in hrQOL, acoustic rhinometry (ARM), peak nasal inspiratory flow (PNIF), olfaction test (Sniffin’ Sticks, identification and threshold), pathologic findings, safety and costs. The patient will know the treatment arm at 12 months post-starting with the treatment) and can discuss with the doctor of the need to continue or start with ASA-desensitization or another treatment, if needed. | — |
Countries
Finland
Contacts
Public ContactSkin and Allergy Hospital
Helsinki University Hospital
Outcome results
None listed