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New treatment option for Asthma
Official title Moving Towards Precision Medicine in United Airways Disease: Unraveling Inflammatory Patterns in Asthmatic Patients With or Without Nasal Polyps
ClinicalTrials.gov ID: NCT05009758
What this study is testing
- What it's testing
- 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.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 99
You may be able to join if
- 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
You likely can't join if
- 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
See the full eligibility 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...
- 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
- 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...
- 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 \ 10 pack-years
The study team makes the final eligibility decision.
Where it's taking place
- Vienna, Austria
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 99 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Vienna, Austria. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.