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
• Status: Completed
• 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
• 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.

Related Conditions & MeSH terms

• Asthma
• Eosinophilic Asthma
• Pulmonary Eosinophilia

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

External Links

•   Mayo Clinic Clinical Trials