Changes in Gene Transcription and Immunophenotypes Following Mepolizumab Treatment for Asthma

NCT05002621 | Completed Results

• 1 other identifier: 20-005018
• Study Type: observational
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Eosinophilic Asthma

Outcome Measures

Primary Outcomes (1)

• Differentially Expressed Genes

  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.

  12 weeks post initiation of mepolizumab

Study Arms (1)

severe eosinophilic asthma (SEA)

Twenty consecutive patients who were diagnosed with SEA by a health care provider were prospectively enrolled

Other: Observational

Interventions

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.

severe eosinophilic asthma (SEA)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

This study will involve twenty adult (≥18yo) individuals with a diagnosis of severe eosinophilic asthma (SEA) who have been prescribed mepolizumab during their course of routine clinical care.

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Mayo Clinic: lead

Study Sites (1)

Mayo Clinic in Rochester

Rochester, Minnesota, 55905, United States

Location

Related Links

• Mayo Clinic Clinical Trials

MeSH Terms

Conditions

Pulmonary Eosinophilia

Interventions

Watchful Waiting

Condition Hierarchy (Ancestors)

Lung Diseases; Respiratory Tract Diseases; Hypereosinophilic Syndrome; Eosinophilia; Leukocyte Disorders; Hematologic Diseases; Hemic and Lymphatic Diseases

Intervention Hierarchy (Ancestors)

Outcome Assessment, Health Care; Outcome and Process Assessment, Health Care; Quality of Health Care; Health Services Administration

Results Point of Contact

• Title: Thanai Pongdee
• Organization: Mayo Clinic

bachman.kay@mayo.edu

507-284-3783

Study Officials

• Thanai Pongdee, MD

  Mayo Clinic

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: August 9, 2021
• First Posted: August 12, 2021
• Study Start: February 16, 2021
• Primary Completion: February 13, 2023
• Study Completion: December 11, 2025
• Last Updated: March 18, 2026
• Results First Posted: March 18, 2026

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF

Locations

US (1)