Moving Towards PREcision Medicine In United Airways Disease: Unraveling inflaMmatory Patterns in Asthmatic Patients With or Without Nasal Polyps (PREMIUM) - a Descriptive Pilot Study

Status: Recruiting
Location: See location...
Intervention Type: Procedure, Diagnostic test, Other
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

Asthma and chronic rhinosinusitis (CRS) are inflammatory diseases of the respiratory tract, asthma from the lower part, and CRS, from the upper part. In theory, these parts are correlated as if they are one single organ, namely united airways, which means that if one is affected by any condition, the other might be impacted as well. However, this relationship has not yet been described down to the cellular and molecular levels. By investigating patients that have (1) asthma and CRS with nasal polyp, (2) asthma and CRS without nasal polyp, and (3) just CRS with nasal polyp, we aim to determine the correlation of the upper and lower part of the respiratory tract. At first, the characterization of disease will be determined by established clinical criteria, such as lung function, blood analysis for the presence of eosinophils (a type of white cells), and nasal polyp score. To continue, in-depth analysis of nose, oropharynx, and lung samples will help gain information about the inflammatory profile and local microbiome of the three different groups of patients through molecular and cellular assays. The results of this study will help to describe the hypothesis of the united airways which will provide better guidance for medical treatment of asthma and CRS with or without polyp, thus improving the life quality of patients.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 99
Healthy Volunteers: f
View:

‣ All patients who

• 18-99 years of age

• have a recorded clinical diagnosis of asthma (ICD-10 Code: J45)

• undergo moderate-serve asthma treatment according to GINA/DAL treatment step 4 or step 5 without oral corticosteroid or monoclonal antibody therapy

• Asthma treatment for a minimum of 12 weeks prior to screening visit

⁃ Group 1 and 2 - T2-high asthma with or without polyps:

• FeNO \> 25 ppB

• had either two times \>= 250 eosinophils /µl measured in the blood OR one measurement of blood eosinophils \>= 250 cells/µl (one of the two measurements at the screening visit) and/or one measurement of sputum eosinophils \> 2% within the last 12 months

• Group with polyps: Presence of CRSwNP as confirmed by endoscopy or CT according to the European Position Paper on Rhinosinusitis and CRSwNP Guidelines)

⁃ Group 3 - CRSwNP in absence of asthma:

• Presence of CRSwNP as confirmed by endoscopy or CT according to the European Position Paper on Rhinosinusitis and Nasal Polyps Guidelines

• Evidence of Type 2 inflammation: eosinophils \>= 250 cells/µl measured in the blood OR total IgE \>100 kU/L at the screening visit

• Absence of asthma and N-ERD

• Patients with a history of treatment with monoclonal antibodies for asthma or polyps will only be included if at least a wash out period of 5 half-lives or at least 3 months have passed

Locations
Other Locations
Austria
Allgemeines Krankenhaus (AKH) Wien
RECRUITING
Vienna
Contact Information
Primary
Julia Eckl-Dorna, PhD
julia.eckl-dorna@meduniwien.ac.at
+4314040034380
Backup
Sven Schneider, MD
sven.schneider@meduniwien.ac.at
+4314040034380
Time Frame
Start Date: 2021-09-01
Estimated Completion Date: 2026-12
Participants
Target number of participants: 30
Treatments
Active_comparator: T2-high asthma with nasal polyps
* FeNO \> 25 ppB~* Had either two times \>= 250 eosinophils /µl measured in the blood OR one measurement of blood eosinophils \>= 250 cells/µl (one of the two measurements at the screening visit) and/or one measurement of sputum eosinophils \> 2% within the last 12 months~* Presence of CRSwNP as confirmed by endoscopy or CT according to the European Position Paper on Rhinosinusitis and CRSwNP Guidelines)~* Patients with a history of treatment with monoclonal antibodies for asthma or polyps will only be included if at least a washout period of 5 half-lives or at least 3 months have passed
Active_comparator: T2-high asthma without nasal polyps
* FeNO \> 25 ppB~* Had either two times \>= 250 eosinophils /µl measured in the blood OR one measurement of blood eosinophils \>= 250 cells/µl (one of the two measurements at the screening visit) and/or one measurement of sputum eosinophils \> 2% within the last 12 months~* Absence of NP as confirmed by endoscopy or CT according to the European Position Paper on Rhinosinusitis and CRSwNP Guidelines)~* Patients with a history of treatment with monoclonal antibodies for asthma or polyps will only be included if at least a washout period of 5 half-lives or at least 3 months have passed
Active_comparator: CRSwNP in absence of asthma
* Presence of CRSwNP as confirmed by endoscopy or CT according to the European Position Paper on Rhinosinusitis and Nasal Polyps Guidelines26~* Evidence of Type 2 inflammation: blood eosinophils \>= 250 cells/µl measured in the blood OR total IgE \>100 kU/L26 at the screening visit~* Absence of asthma and N-ERD~* Patients with a history of treatment with monoclonal antibodies for asthma or polyps will only be included if at least a washout period of 5 half-lives or at least 3 months have passed
Sponsors
Leads: Medical University of Vienna

This content was sourced from clinicaltrials.gov

Similar Clinical Trials