Nasal Inflammation Following Endotoxin Challenge in Patients With Asthma
Trial statusNot yet recruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18+
SponsorNational Jewish Health
About this trial
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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
Participants will have asthma diagnosed by a health care provider. Healthy controls are individuals without asthma.
Written informed consent
Disqualifiers
Current or recent illness (in the past 4 weeks)
Recent asthma exacerbation (past 4 weeks)
History of nasal perforation or nasal surgery
Nasal polyposis
Trial design
Design model
Parallel
Treatments tested in this trial
Lipopolysaccharides
DrugLPS 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.
Treatment groups
60 Participants
are divided into 2 treatment groupsGroup A: Asthma GroupActive comparator 1 intervention
Group B: Control GroupActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
Neutrophil heterogeneity using single cell RNA sequencing
Neutrophil subset composition as determined by single cell RNAseq is compared to endotype groups using a multivariate linear regression framework for compositional data, employing the additive log ratio transformation. Models will include indicator variables for whether a sample is T1 high, T2 high, T17 high or non-asthmatic and will control for age, sex, and smoking status. AM subset gene expression matrices from scRNAseq will be compared between endotypes using the pseudo bulk approach to account for clustering of cells within subjects. To identify global gene expression programs underlying each endotype, bulk RNAseq gene expression data will be normalized using DESeq2's variance stabilizing transformation and similarly compared between endotypes using linear regression models. A Benjamini-Hochberg adjustment will be used to control the false discovery rate.
Time frame
We anticipate that the study will run over 5 yearsSponsors and contacts
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Source ClinicalTrials.gov
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