Changes in Gene Transcription and Immunophenotypes Following Mepolizumab Treatment for Asthma

NCT ID: NCT05002621

Last Updated: 2023-03-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

20 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-02-16

Study Completion Date

2023-02-13

Brief Summary

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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

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Conditions

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Eosinophilic Asthma

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Mayo Clinic

OTHER

Sponsor Role lead

Responsible Party

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Thanai Pongdee

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Thanai Pongdee, MD

Role: PRINCIPAL_INVESTIGATOR

Mayo Clinic

Locations

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Mayo Clinic in Rochester

Rochester, Minnesota, United States

Site Status

Countries

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United States

Related Links

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Other Identifiers

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20-005018

Identifier Type: -

Identifier Source: org_study_id

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