chronic rhinosinusistis, polyposis nasi, aspirin intolerance
Conditions
Interventions
Product Name: acetylsalicylic acid
Product Code: B01AC06
Pharmaceutical Form: Capsule*
INN or Proposed INN: acetylsalicylic acid
CAS Number: 50-78-2
Concentration unit: mg milligram(s)
Concentration t
Sponsors
Department of Otolaryngology, Head and Neck Surgery Johannes Gutenberg-Universität Mainz
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: age mor than 18, polyposis nasi, clinical signs of ASS-intolerance and pathological variations of the eicosanoid metabolism in vitro, actual state after endonasal sinus surgery in case of chronic rhinosinusitis. 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 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: systemical treatment with steroids within the last 3 weeks befor beginning of the study, pregnency, Active peptic ulcer Haemostatic disorders, including anticoagulant and thrombolytic treatment Hypoproteinemia hepatic or renal insufficiency immune deficiency glucose-6-phosphatase deficiency
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: evidence of the effectiveness of a long-time ASS-desactivation therapy as a prevention of recurrence of polyposis nasi after sinus surgery in cases of recurrent chronic sinusitis with ASS-intolerance;Secondary Objective: Get mor information about the pathological eicosanoid metabolism and the incluence of longtime ASS-therapy;Primary end point(s): ate of recurrence of poyposis nasi/chronic rhinosinusitis after 3 years of ASS-desactivation therapy, tested in radomised, double-blind and pacebo-controled way | — |
Countries
Germany
Outcome results
None listed