Chronic rhinosinusitis and nasal polyposis a GA2LEN cohort study - Chronic rhinosinusitis and nasal polyposis a GA2LEN cohort study

Academisch Medisch Centrum0 个研究点目标入组 125 人开始时间: 待定最近更新: 2024年5月13日

适应症

试验速览

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•1. The subject understands the study procedures and agrees to participate by signing the consent form.
•2. The subject is male or female, at least 18 years of age but no more than 60 years of age
•3. Subjects must be in good health, free of any clinically significant disease that would interfere with the study or procedures or compromise his/her safety.
•4.Diagnosis of chronic rhinosinusitis:
•The diagnosis of chronic rhinosinusitis (with or without nasal polyps, including fungal disease, Cystic fibrosis, etc.) based on the EP3OS definition ;For controls: Controls are patients undergoing surgery such as septoplasty or septorhinoplasty, who have no medical history or symptoms of any form of chronic rhinosinusitis

•1. Patients with a recent acute exacerbation of rhinosinusitis (past two weeks) are not allowed to participate
•2. The subject had functional endoscopic sinus surgery (FESS) before, with removal of parts of the lateral nasal wall. Polypectomy, septal or inferior turbinate surgery is allowed.
•3. Women must not be pregnant or breast feeding
•4. The subject is a current or recent past abuser of alcohol or illicit drugs
•5. The subject has a history of malignancy, is known to be positive for HIV, has immunodeficiencies or other states that are considered to interfere with study conduct or scientific interpretations.
•6. Subjects must not be known to have sarcoidosis
•7. Subjects must not be known to have any type of vasculitis (including Wegener)
•8. Subjects must not be known to be positive to hepatitis B surface antigen or C antibodies.
•9. The subject cannot read or comprehend written material, or is in the opinion of the investigator, for other reasons unlikely to understand and follow the study procedures.
•10. The subject is mentally or legally incapacitated preventing informed consent from being obtained.
•11. Medication: For Visit 2 a wash-out period for the medications (oral steroids 4 weeks, Nasal steroids 2 weeks, anti-leukotrienes 2 weeks) is mandatory, for visit 1 the wash-out period is advisable although patients using this medication can be included.
•12. Inhalation steroids for asthma are permitted but should be documented in the questionnaires.

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