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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| severe eosinophilic asthma (SEA) | Twenty consecutive patients who were diagnosed with SEA by a health care provider were prospectively enrolled |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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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.
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| Name | Affiliation | Role |
|---|---|---|
| Thanai Pongdee, MD | Mayo Clinic | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Mayo Clinic in Rochester | Rochester | Minnesota | 55905 | United States |
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| Label | URL |
|---|---|
| Mayo Clinic Clinical Trials | View source |
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De-identified individual participant data (IPD) underlying the RNA sequencing results reported in this study will be made available upon reasonable request, beginning after publication of the primary results and for up to five years thereafter. Requests may be submitted to the study PI and will be reviewed based on scientific merit, feasibility, and compliance with applicable ethical and regulatory requirements. Data will be shared under a data use agreement, and only de-identified data will be provided to protect participant confidentiality.
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No significant events occurred between the enrollment and assignment of participants to an arm or group.
20 subjects were recruited.
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| ID | Title | Description |
|---|---|---|
| FG000 | Severe Eosinophilic Asthma | This study involved twenty adult (≥18yo) individuals with a diagnosis of severe eosinophilic asthma (SEA) who had been prescribed mepolizumab during their course of routine clinical care. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Severe Eosinophilic Asthma | This study involved twenty adult (≥18yo) individuals with a diagnosis of severe eosinophilic asthma (SEA) who had been prescribed mepolizumab during their course of routine clinical care. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Median |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | Posted | Number | differentially expressed gene | 12 weeks post initiation of mepolizumab |
|
from enrollment until end of follow-up, up to 12 weeks
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Severe Eosinophilic Asthma | This study involved twenty adult (≥18yo) individuals with a diagnosis of severe eosinophilic asthma (SEA) who had been prescribed mepolizumab during their course of routine clinical care. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Thanai Pongdee | Mayo Clinic | 507-284-3783 | bachman.kay@mayo.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Dec 11, 2025 | Jan 18, 2026 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D011657 | Pulmonary Eosinophilia |
| ID | Term |
|---|---|
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D017681 | Hypereosinophilic Syndrome |
| D004802 | Eosinophilia |
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| ID | Term |
|---|---|
| D057832 | Watchful Waiting |
| ID | Term |
|---|---|
| D017063 | Outcome Assessment, Health Care |
| D010043 | Outcome and Process Assessment, Health Care |
| D011787 | Quality of Health Care |
| D006298 | Health Services Administration |
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| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| peak absolute eosinophil count | Median | Inter-Quartile Range | cell count |
|
| Units | Counts |
|---|
| Participants |
|
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| 0 |
| 20 |
| 0 |
| 20 |
| 0 |
| 20 |
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| D007960 |
| Leukocyte Disorders |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |