Aggravated airway inflammation: research on genomics and optimal treatments (AirGOs) - AirGOs

Helsinki University Hospital0 个研究点目标入组 150 人开始时间: 2018年4月19日最近更新: 2018年5月14日

适应症

试验速览

暂无简介。

•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.
•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

•Age <18 years, 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.

发起方

Helsinki University Hospital