Investigating Inflammatory Patterns in Asthma and Nasal Polyps
Moving Towards PREcision Medicine In United Airways Disease: Unraveling inflaMmatory Patterns in Asthmatic Patients With or Without Nasal Polyps (PREMIUM) - a Descriptive Pilot Study
This study is trying to see how asthma and nasal polyps are connected by looking at patients with both conditions to better understand their inflammation patterns.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 30 (estimated) |
| Ages | 18 Years to 99 Years |
| Sex | All |
| Sponsor | Medical University of Vienna Academic / other |
| Drugs / interventions | omalizumab, dupilumab, reslizumab |
| Locations | 1 site (Vienna) |
| Trial ID | NCT05009758 on ClinicalTrials.gov |
What this trial studies
This study explores the relationship between asthma and chronic rhinosinusitis (CRS) by examining patients with asthma and CRS with or without nasal polyps. It aims to characterize these conditions through clinical assessments, including lung function tests and blood analysis for eosinophils. Additionally, the study will involve in-depth sampling from the nose, oropharynx, and lungs to understand the inflammatory profiles associated with these diseases. The goal is to uncover the cellular and molecular connections between the upper and lower respiratory tracts, which are thought to function as a single organ.
Who should consider this trial
Good fit: Ideal candidates include adults aged 18-99 with a clinical diagnosis of asthma undergoing moderate to severe treatment without corticosteroids or monoclonal antibodies.
Not a fit: Patients who do not have asthma or chronic rhinosinusitis, or those not meeting the specific inclusion criteria, may not benefit from this study.
Why it matters
Potential benefit: If successful, this research could lead to more precise treatments for patients suffering from asthma and CRS, improving their quality of life.
How similar studies have performed: Other studies have shown promising results in understanding the link between asthma and CRS, but this specific approach to unraveling inflammatory patterns is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 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 Exclusion Criteria: * Pregnancy (as determined by ß-HCG test) * Patients with severe anatomic variations or deviations that do not allow access to all areas in the nasal cavity * Patients undergoing chronic oral corticosteroid therapy * Patients with any other confounding underlying lung disorder including but not limited to: * Bronchiectasis, chronic obstructive pulmonary disorder (COPD), pulmonary fibrosis, emphysema, primary ciliary dyskinesia * Cystic fibrosis, any known parasitic infections, and lung cancer * Patients with pulmonary conditions with symptoms of asthma and blood eosinophilia including but not limited to: Eosinophilic granulomatosis with polyangiitis (EGPA), allergic bronchopulmonary aspergillus, and hypereosinophilic syndrome * A mental condition rendering the subject unable to understand the nature, scope, and possible consequences of the study * Patients with clinically meaningful comorbidity as determined by the evaluating committee * Patients with a history of exacerbation of chronic rhinosinusitis or asthma 4 weeks prior to any visit * Intake of a burst of systemic corticosteroids 4 weeks prior to any visit. * Immunosuppressive treatment (e.g. cyclosporine) * Drug and alcohol abuses * Current smoker * Former smoker if stopped smoking \<6 months and/or has \>10 pack-years
Where this trial is running
Vienna
- Allgemeines Krankenhaus (AKH) Wien — Vienna, Austria (Recruiting)
Study contacts
- Principal investigator: Julia Eckl-Dorna, PhD — Medical University of Vienna
- Study coordinator: Julia Eckl-Dorna, PhD
- Email: julia.eckl-dorna@meduniwien.ac.at
- Phone: +4314040034380
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.