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NCT05002621 Clinical Trial

Changes in Gene Transcription and Immunophenotypes Following Mepolizumab Treatment for Asthma

Eosinophilic Asthma Clinical Trial

Official title:
Exploratory Investigation of Changes in Gene Transcription and Immunophenotypes Following Mepolizumab Treatment for Asthma

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT05002621
Other study ID # 20-005018
Secondary ID
Status Completed
Phase
First received
Last updated
Start date February 16, 2021
Est. completion date February 13, 2023

Study information
Verified date March 2023
Source Mayo Clinic
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

The purpose of this study is to identify gene transcripts after initiation of mepolizumab in individuals with severe eosinophilic asthma (SEA), and to determine the composition of immune cells present in the microenvironment of individuals with SEA after initiation of mepolizumab.

Recruitment information / eligibility
Status Completed
Enrollment 20
Est. completion date February 13, 2023
Est. primary completion date February 13, 2023
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - Age = 18 years old. - Diagnosis of SEA by a health care provider - History of an absolute eosinophil count = 300/mm^3 - Prescription for mepolizumab provided during course of routine clinical care but mepolizumab not yet started Exclusion Criteria: - Age < 18 years old. - Pregnancy. - Currently using or have used within 3 months of the initial baseline visit any biologic or immunomodulatory therapy with the exception of #3. - Currently using or any prior use of rituximab. - History of upper/lower respiratory tract infection or asthma exacerbation within the previous four weeks of the first baseline visit. - Any prior history of malignancy, autoimmune disease, or immune deficiency. - Any other significant medical issue as determined by the principal investigator.

Study Design

Related Conditions & MeSH terms

Locations
Country Name City State
United States Mayo Clinic in Rochester Rochester Minnesota

Sponsors (1)
Lead Sponsor Collaborator
Mayo Clinic

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Expressed gene transcripts RNA sequencing will be performed from collected peripheral blood mononuclear cells (PBMCs) at four time points to compare changes in expressed gene transcripts. Baseline and 4, 8, and 12 weeks post-initiation of mepolizumab
Primary Composition of immune cell subsets CyTOF mass cytometry (50 test immune phenotype panel including cell surface markers, transcription factors, and cytokines) will be performed on PBMCs isolated from peripheral blood at four time points. Baseline and 4, 8, and 12 weeks post-initiation of mepolizumab
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