Changes in Gene Transcription and Immunophenotypes Following Mepolizumab Treatment for Asthma

Completed

• Conditions: Eosinophilic Asthma

• Registration Number: NCT05002621
• Lead Sponsor: Mayo Clinic

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2021-02-16
• Study First Submitted: 2021-08-09
• Study First Submitted QC: 2021-08-09
• Study First Posted: 2021-08-12
• Primary Completion: 2023-02-13
• Study Completion: 2023-02-13
• Status Verified: 2023-03
• Last Update Submitted: 2023-03-27
• Last Update Posted: 2023-03-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 20

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

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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.

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Expressed gene transcripts	Baseline and 4, 8, and 12 weeks post-initiation of mepolizumab	RNA sequencing will be performed from collected peripheral blood mononuclear cells (PBMCs) at four time points to compare changes in expressed gene transcripts.
Composition of immune cell subsets	Baseline and 4, 8, and 12 weeks post-initiation of mepolizumab	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.

Trial Locations

Locations (1)

Mayo Clinic in Rochester; 🇺🇸 Rochester, Minnesota, United States