Eosinophilic Asthma
Conditions
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).
Interventions
OTHERObservational
Enrolled patients had a prescription for mepolizumab provided during the course of routine clinical care, and enrollment occurred prior to the initiation of mepolizumab.
Sponsors
Mayo Clinic
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Differentially Expressed Genes | 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. |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORThanai Pongdee, MD
Mayo Clinic
Participant flow
Recruitment details
20 subjects were recruited.
Pre-assignment details
No significant events occurred between the enrollment and assignment of participants to an arm or group.
Baseline characteristics
| Characteristic | — |
|---|---|
| Age, Continuous | 51.5 years |
| peak absolute eosinophil count | 880 cell count |
| Sex: Female, Male Female | 13 Participants |
| Sex: Female, Male Male | 7 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 20 |
| other Total, other adverse events | 0 / 20 |
| serious Total, serious adverse events | 0 / 20 |
Outcome results
None listed