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

Phase 1

• Conditions: Acetylsalicylic acid (ASA-) exacerbated respiratory disease (AERD).; Therapeutic area: Body processes [G] - Circulatory and Respiratory Physiological Phenomena [G09]

• Registration Number: EUCTR2017-001570-42-FI
• Lead Sponsor: Helsinki University Hospital

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2018-04-19
• Last Update Posted: 14 May 2018

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 150

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.

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

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.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified