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

Helsinki University Hospital0 sites150 target enrollmentApril 19, 2018

Overview

Phase: Phase 1
Intervention: Not specified
Conditions: Acetylsalicylic acid (ASA-) exacerbated respiratory disease (AERD).
Sponsor: Helsinki University Hospital
Enrollment: 150
Status: Active, not recruiting
Last Updated: 7 years ago

No summary available.

Registry

who.int

Start Date

April 19, 2018

End Date

TBD

Last Updated

7 years ago

Study Type

Interventional clinical trial of medicinal product

Sex

All

Sponsor

Helsinki University Hospital

•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.