Eosinophilic AsthmaNCT05002621
Changes in Gene Transcription and Immunophenotypes Following Mepolizumab Treatment for Asthma
An observational study of Eosinophilic Asthma, run by Mayo Clinic at 1 site in United States.
Trial summary
The purpose of this study is to identify differentially expressed gene transcripts after initiation of mepolizumab in individuals with severe eosinophilic asthma (SEA). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Eosinophilic Asthma
- What is being tested?
- Observational
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- 16 Feb 2021to 11 Dec 2025
- Phase
- Observational
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
Mayo Clinic in Rochester
Rochester, Minnesota, 55905
About this study
Official title: Exploratory Investigation of 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).
- Conditions
- Eosinophilic Asthma
- Being tested
- Observational
- Medical subject headings
- Pulmonary Eosinophilia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ObservationalOther
Enrolled patients had a prescription for mepolizumab provided during the course of routine clinical care, and enrollment occurred prior to the initiation of mepolizumab.
| Study group | Role | What they receive |
|---|---|---|
| severe eosinophilic asthma (SEA) | Twenty consecutive patients who were diagnosed with SEA by a health care provider were prospectively enrolled Receives: Other: Observational |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 12 weeks post initiation of mepolizumab
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Aug 2021
- Study start16 Feb 2021
- Primary completion13 Feb 2023
- Study completion11 Dec 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Eosinophilic AsthmaStudies of the same condition, open and under way.
- More trials run by Mayo ClinicThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mayo Clinic
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Thanai Pongdee, Mayo Clinic
- Investigators
- Thanai Pongdee, MD, Principal investigator, Mayo Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05002621
- Sponsor's protocol ID
- 20-005018
- Status last verified
- Dec 2025
- First submitted
- 9 Aug 2021
- Last updated
- 18 Mar 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.
Study at a glance
From the registry record, last updated by the sponsor on 18 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Exploratory Investigation of Changes in Gene Transcription and Immunophenotypes Following Mepolizumab Treatment for Asthma
- ClinicalTrials.gov ID
- NCT05002621
- Acronym / sponsor ID
- 20-005018
- Conditions
- Eosinophilic Asthma
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Mayo ClinicUniversity, hospital or other
- Study start
- 16 Feb 2021 (actual)
- Primary completion
- 13 Feb 2023 (actual)
- Study completion
- 11 Dec 2025 (actual)
- First posted
- 12 Aug 2021 (actual)
- Results
- Posted 18 Mar 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to identify differentially expressed gene transcripts after initiation of mepolizumab in individuals with severe eosinophilic asthma (SEA).
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| severe eosinophilic asthma (SEA) | – | Other: ObservationalTwenty consecutive patients who were diagnosed with SEA by a health care provider were prospectively enrolled |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (7 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ObservationalEnrolled patients had a prescription for mepolizumab provided during the course of routine clinical care, and enrollment occurred prior to the initiation of mepolizumab. | Other | severe eosinophilic asthma (SEA) |
Primary outcome
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.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Mar 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Mayo Clinic Clinical TrialsLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. 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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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Thanai Pongdee, MD principal investigator
Mayo Clinic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Eosinophilic Asthma, run by Mayo Clinic at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 18 Mar 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Differentially Expressed Genes (time frame: 12 weeks post initiation of mepolizumab). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Mar 2026.