EUFOREA consensus on biologics for CRSwNP with or without asthma.
Wytske J Fokkens, Valerie Lund, Claus Bachert...
https://pubmed.ncbi.nlm.nih.gov/31090937Actively Recruiting
Age: 18Years +
All Genders
ID05935683
Rhinosinusitis Italian Network (RINET): the Italian Registry for Severe, Uncontrolled Chronic Rhinosinusitis
Led by Italian Academy of Rhinology · Updated on 2024-07-19
5000
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
Sponsors
I
Italian Academy of Rhinology
Lead Sponsor
A
Accademia Italiana di Citologia Nasale
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are collecting data from patients in Italy with severe, uncontrolled Chronic Rhinosinusitis (CRS) through a registry called the Rhinosinusitis Italian Network (RINET). This observational study aims to better understand the progression of uncontrolled CRS, identify different types of the condition, evaluate various treatments used in real clinical settings, and support the development of new diagnostic and treatment methods. The study also seeks to raise awareness about CRS among patients, the public, and medical professionals such as otolaryngologists, allergists, and pneumologists. Participants will be treated by a multidisciplinary team including allergists, otolaryngologists, and pneumologists, reflecting real-life clinical care. The study collects information on the use and effects of treatments like systemic corticosteroids and records therapeutic decisions to understand their impact on the disease's natural course. Data will be gathered longitudinally from patients attending specialist centers across Italy. Participants will be followed over time with annual assessments, including the Nasal Polyp Score to monitor disease status. Other evaluations include quality of life measures, symptom scales, and biological markers of inflammation. The study aims to track clinical outcomes and the economic impact of treatments. Participation involves regular visits to specialist centers where clinical data, questionnaires, and laboratory samples may be collected to support a comprehensive understanding of uncontrolled CRS.
CONDITIONS
Brief Title
Rhinosinusitis Italian Network: the Italian Registry for Severe, Uncontrolled Chronic Rhinosinusitis
Who Can Participate
Age: 18Years +
All Genders
Eligibility Criteria
You may qualify if you...
- Adults aged 18 years or older
- Confirmed diagnosis of bilateral Chronic Rhinosinusitis
- For patients previously treated with surgery: meet at least three of the following criteria
- For patients never treated with nasal sinus surgery: meet at least four of the following criteria
- Evidence of type 2 inflammation including blood eosinophils, sinus mucosa histology, nasal cytology, or elevated serum IgE
- At least two short courses or long-term systemic corticosteroid therapy for Chronic Rhinosinusitis
- Significant worsening in quality of life measured by SNOT-22 score of 40 or higher or VAS symptom score of 5 or higher
- Loss of smell with a hyposmia VAS score of 7 or higher
You will not qualify if you...
History of severe allergic reactions to study medication Currently pregnant or breastfeeding Recent participation in another clinical trial within the last 30 days Presence of uncontrolled medical conditions that could affect safety
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
1
2
3
Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Long-term Monitoring
Duration - Up to 10 years
Participants are observed over a long period to study the evolution and treatment outcomes of severe, uncontrolled Chronic Rhinosinusitis.
Annual visits
Trial Site Locations
Total: 1 location
1
Personalized Medicine, Asthma and Allergy - IRCCS Humanitas Research Hospital
Rozzano, MIlan, Italy, 20089
Actively Recruiting
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Research Team
E
Enrico Marco Heffler, MD, PhD
C
Concetta Sirena, Dr.
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
0
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Published Research Related To This Trial
European Position Paper on Rhinosinusitis and Nasal Polyps 2020.
W J Fokkens, V J Lund, C Hopkins...
https://pubmed.ncbi.nlm.nih.gov/32077450