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OpenTrials
Completed

NCT Number: NCT05002621

Changes in Gene Transcription and Immunophenotypes Following Mepolizumab Treatment for Asthma

The purpose of this study is to identify differentially expressed gene transcripts after initiation of mepolizumab in individuals with severe eosinophilic asthma (SEA).

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Mayo Clinic in Rochester

Rochester, Minnesota, 55905, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Observational

Other

Enrolled patients had a prescription for mepolizumab provided during the course of routine clinical care, and enrollment occurred prior to the initiation of mepolizumab.

Primary outcomes

  1. Differentially Expressed Genes

    Time frame: 12 weeks post initiation of mepolizumab

    Peripheral blood mononuclear cells (PBMCs) were isolated from blood samples for bulk RNA sequencing. Paired differential expression (DE) gene analysis was performed comparing baseline gene expression versus 12 weeks post initiation of mepolizumab.

Sponsors and collaborators

Lead sponsor

Mayo Clinic

Other

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2023
Study completion
2025
First posted
Aug 12, 2021
Registry last updated
Mar 18, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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