An observational study in Asthma, sponsored by Washington University School of Medicine. Completed at 1 site in United States. Open to participants aged 6 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-08-19.
Sponsored by Washington University School of Medicine · Observational
The overall goal of this proposal is to better understand the basis of airway remodeling in severe asthma and how remodeling changes over time. The investigators propose to study a well-characterized cohort of adult and pediatric subjects with severe asthma using a multidisciplinary state-of-the-art approach.
The overall goal of this proposal is to better understand the molecular basis and structural and physiologic consequences of airway remodeling in severe asthma and how remodeling changes over time. In that context, the investigators propose to study a well-characterized cohort of adult and pediatric subjects with severe asthma using a multidisciplinary approach that includes state-of-the-art morphometric, imaging, and physiologic measurements of airways. The investigators will contrast these findings to those in groups with well-controlled asthma, normal controls, and diseased controls (chronic bronchitis) to identify features that can provide biologic targets unique to severe asthma. The investigators have demonstrated that epithelial hyperplasia, goblet cell metaplasia and mucin production are features of airway remodeling in subjects with severe asthma, and that epithelial remodeling was due to increased epithelial proliferation and decreased cell death. The investigators propose that individuals with severe asthma, in comparison to well controlled asthma, have: (I) increased airway remodeling as evidenced by goblet cell metaplasia and mucin production, (II) greater airway thickness by multidetector-row CT of the chest (MDCT) leading to ventilation defects demonstrated by hyperpolarized helium (3He) MRI and air trapping demonstrated by MDCT, and (III) airway remodeling associated with more severe and progressive airflow obstruction. The investigators hypothesize that the goblet cell metaplasia and increased mucin The investigators have observed in severe asthma are being driven by an IL-13- and EGFR-dependent mechanism that inhibits epithelial cell apoptosis and allows IL-13 differentiation of the airway epithelium into goblet cells (Aim I). The investigators further hypothesize that this remodeling of segmental airways in severe asthma leads to distal ventilation defects and air trapping (Aim II). In an effort to define potential predictors of subsequent decline in lung function in severe asthma, the investigators hypothesize that baseline airway remodeling as reflected by MDCT airway wall area (AWA%) is predictive of FEV1 (post-corticosteroid/bronchodilator FEV1) decline (Aim III). The identification of potential variables associated with remodeling and severe asthma will help identify individuals at risk whom would benefit from specific targeted therapy. The concerted efforts of this project together with the SARP will lead to new insights on the mechanistic basis for severe asthma, further elucidate how it differs from mild-moderate asthma, identify potential targets for intervention, and will provide imaging metrics to objectively evaluate outcomes for new treatments.
3,921 studies on the registry are indexed under Asthma; 507 are open to participants now.
This study's enrollment of 121 is below the median of 150 across 970 observational studies indexed under Asthma.
Browse Asthma studies →Washington University School of Medicine is the lead sponsor of 1,765 studies on the registry; 271 are open to participants now.
Of its 324 completed or terminated interventional studies of FDA-regulated products, 212 (65%) have results posted.
Counted across the registry records on this site, refreshed daily.
Subjects with asthma (severe asthma, well controlled asthma) and healthy normal controls from St. Louis region
Evidence of historical reversibility, including either:
Exclusion Criteria:
Subjects with severe asthma (SARP protocol definition)
Subjects with well controlled asthma
Subjects that are healthy normals
Lung function
decline in lung function (FEV1) over 3 yrs
Time frame: 3 yrs
Asthma Control Questionnaire
asthma control score (ACQ)
Time frame: 3 yrs
Health care utilization
Health care utilization including ED visits and hospitalizations.
Time frame: 3 yrs
Exacerbation
Exacerbations requiring systemic steroids
Time frame: 3 yrs
CT quantification
CT airway wall thickness, lung density
Time frame: 3 yrs
MRI
Ventilation defects on hyperpolarized gas MRI
Time frame: 3 yrs
Morphometric biopsy
Morphometric analysis of airway biopsies
Time frame: 3 yrs
Gene expression
Gene expression studies of airway epithelial cells
Time frame: 3 yrs
This study is completed, as verified in Aug 2026. You cannot join it, but the record below documents what was studied.
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Washington University School of Medicine