Nasal Inflammation Following Endotoxin Challenge in Patients With Asthma

Part of paid clinical trials in Denver, Colorado.

Sponsor
National Jewish Health
Study ID
NCT06270576
Phase
PHASE1
Status
Not Yet Recruiting

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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Accepted

Interventions

  • Lipopolysaccharides — DRUG
    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.

Study Details

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.

Key Dates

Start date
Apr 30, 2024
Status verified
Feb 2024
Primary completion
Apr 30, 2028
Completion
Jun 30, 2028

Study Design

Enrollment
60 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE

Arms

  • Active Comparator: Asthma Group
    Subjects diagnosed with one of the three asthma endotypes being studied (T2, T1, or T17).
  • Active Comparator: Control Group
    Subjects with no diagnosis of asthma or other respiratory disease and are deemed healthy.

Primary Outcome Measure

Neutrophil heterogeneity using single cell RNA sequencing [ Time Frame: We anticipate that the study will run over 5 years ]

Locations (1)

FacilityCityStateZIPSite coordinators
National Jewish HealthDenverColorado80206
William J Janssen, MD
303-398-1366
Olivia M VerBurg, BA
303-398-1201
William J Janssen, MD (PRINCIPAL_INVESTIGATOR)

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