Nasal Inflammation Following Endotoxin Challenge in Patients With Asthma
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Lipopolysaccharides.
- Who it may be relevant to
- Registry conditions: Asthma; Eosinophilic, Asthma. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Nasal Endotoxin Challenge to Study Mucosal Inflammation in Patients With Asthma
Overview
A phase I clinical research study aimed at determining mechanisms that regulate airway mucosal inflammation in asthma endotypes using intranasal administration of endotoxin (lipopolysaccharide from E. coli) in healthy controls and subjects diagnosed with asthma.
Detailed description
Patients with severe asthma can be broadly classified into three endotypes (T2, T1, and T17) based on inflammatory cell and cytokine profiles. Within these endotypes, many patients have high levels of neutrophils in the airways and mucosal epithelium. Our preliminary data suggest that neutrophils in the airways and blood of patients with severe asthma are heterogenous and that subsets exist. The nature of these subsets appears to differ between T2, T1, and T17 asthma endotypes.
In order to advance the field and determine the mechanisms that underpin severe neutrophilic asthma, investigators plan to longitudinally assess transcriptional profiles and functional properties of neutrophil subsets that migrate to the nasal cavity following exposure to a standardized dose of Clinical Reference Center endotoxin (IRB#HS-3131-528, IND 018580).
Investigators will recruit 15 subjects of each asthma endotype (45 total participants with asthma) and 15 healthy controls. LPS will be used to elicit migration of neutrophils into the nasal cavities. Neutrophils will be isolated from the nasal cavities using both nasal lavage and nasal brushes 20 minutes, 1 day and 3 days after endotoxin challenge. Neutrophil biology will be assessed using single-cell RNAseq and ex vivo functional assays.
Interventions
- Drug Lipopolysaccharides
LPS aka endotoxin is a component of bacterial cell walls and is ubiquitous in the environment. It is found in pet dander, house dust and environmental dusts and has been heavily studied in asthma.
Primary outcome measures
- Neutrophil heterogeneity using single cell RNA sequencing [Time frame: We anticipate that the study will run over 5 years]
Eligibility criteria
Inclusion criteria
- Participants will have asthma diagnosed by a health care provider. Healthy controls are individuals without asthma.
- Written informed consent
Exclusion criteria
- Current or recent illness (in the past 4 weeks)
- Recent asthma exacerbation (past 4 weeks)
- History of nasal perforation or nasal surgery
- Nasal polyposis
- Presence or prior history of cardiac or systemic disease
- Bleeding disorder, use of systemic anticoagulants, or antiplatelet therapy
- Immunocompromised state (HIV, immunoglobulin deficiency, systemic immunosuppressants excluding corticosteroids)
- Use of tobacco or marijuana in the past 2 months or greater than a 10 pack-year smoking history
- Currently pregnant or breastfeeding
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Allocation
- Non-randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Basic science
Study locations
United States · 1 center
- National Jewish Health — Denver
Identifiers
NCT: NCT06270576 · HS3131