AsthmaNCT05689931

Blood Leukocyte Profiling in Eosinophilic Type 2 Asthma: Influence of Systemic IL-5 Targeting

An observational study of Asthma, run by Region Skane at 1 site in Sweden.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 18 to 80 yearsHealthy volunteers can take part
Conditions the study is for: Asthma
What is being tested?: Mepolizumab and Standard inhaled corticosteroids (ICS) and long-acting beta 2 agonists (LABA)
Type of treatment: Injection or infusion
How many people: 37 participants
Where: 1 siteSweden
Study dates: 1 Jan 2019to 18 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 to 80 years
All sexes
Healthy volunteers accepted
Adult, Older adult

Study population: All asthma patients will be recruited at the Department of Allergology and Lung Medicine, Skåne University Hospital (SUS), Lund, Sweden. Healthy control subjects are recruited by local advertisement.

Who may be able to join

Clinical diagnosis of asthma (the asthma patient arms)
Eligible for Mepolizumab treatment as per the country-specific prescribing information (the arms with Mepolizumab)

Who cannot join

Any diagnosed infection (all arms)
Previous history of lung disease, chronic inflammatory condition, atopy, or cardiovascular disease. Diagnosed or perceived infection within 3 weeks prior to blood sampling (Healthy non-asthma control subjects)

Trial locations and contacts

1 site in 1 country.

Sweden1 site

The Lung and Allergy Clinic, Skåne University Hospital (SUS)
Lund, Skåne County, 22185

Other trials in Sweden

About this study

The goal of this exploratory and observational prospective study is to study the composition and phenotypes of blood leukocytes collected from asthmatic patients before and after instantiated treatment with the interleukin-5 neutralizing antibody mepolizumab. Comparisons will be made to leukocyte profiles in patients already on mepolizumab treatment, asthma patients without any biological treatment, and non-diseased control subjects.

Read the detailed description

Asthma is a chronic inflammatory and obstructive condition affecting the airways. The disease is commonly associated with elevated blood eosinophils and tissue eosinophilia. Many aspects of the pathophysiological mechanisms and clinical symptoms are controlled by conventional therapies such as inhaled corticosteroids (ICS) and long acting β2 agonists. However, some patients remain clinically uncontrolled and need additional treatment such as direct targeting of eosinophil granulocytes by neutralizing the eosinophil-promoting cytokine interleukin 5 (IL5). Mepolizumab is a humanized monoclonal IL-5 neutralizing antibody that is used to treat patients with moderate-severe eosinophilic asthma. While a marked reduction of eosinophils is a key effect of mepolizumab, the exact mechanism of action is unknown. Apart from basophils, that also express the receptor for IL-5, other leukocytes are likely to be indirectly affected by the suppressed eosinophilia. In addition, it is largely unknown to what extent the few eosinophils remaining after anti-IL5 treatment differ from pre-treatment eosinophils.

The present study is a prospective observational asthma study that aims to use microscopic analysis to investigate the composition and subtypes of blood leukocytes collected before and after instantiated mepolizumab treatment. Comparisons are made to patients already on mepolizumab treatment, asthma patients without any biological treatment, and non-diseased control subjects.

Conditions: Asthma
Being tested: Mepolizumab, Standard inhaled corticosteroids (ICS) and long-acting beta 2 agonists (LABA)
Medical subject headings: Asthma

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

MepolizumabBiological
Also called Mepolizumab (brand name: Nucala)
Mepolizumab is administered by subcutaneous injection with guideline recommended patient selection and dosing for treatment of eosinophilic asthma.
Accordingly, the Mepolizumab treatment is given as add-on therapy to standard inhaled corticosteroids (ICS) and long-acting beta 2 agonists (LABA)
Standard inhaled corticosteroids (ICS) and long-acting beta 2 agonists (LABA)Drug
Also called ICS and LABA
Routine asthma treatment with inhaled corticosteroids (ICS) and long-acting beta 2 agonists (LABA)

Study groups in NCT05689931
Study group	Role	What they receive
Asthma patients initiating Mepolizumab treatment		Patients will be selected on the standard criteria used to select eligible asthma patients for mepolizumab treatment (i.e. patients with eosinophilic asthma that are not controlled by conventional high dose ICS and LABA etc). All eligible asthma patients may be included. Exclusion criteria: any infection Receives: Biological: Mepolizumab; Drug: Standard inhaled corticosteroids (ICS) and long-acting beta 2 agonists (LABA)
Asthma patients already on Mepolizumab treatment		Patients that have been selected and given Mepolizumab treatment for > 4 months according to standard eligible and treatment regimen criteria (i.e. patients with eosinophilic asthma that are not controlled by conventional high dose ICS and LABA etc). All eligible asthma patients that have been on Mepolizumab treatment for > 4 weeks will be included. Exclusion criteria: any infections Receives: Biological: Mepolizumab; Drug: Standard inhaled corticosteroids (ICS) and long-acting beta 2 agonists (LABA)
Asthma patients without Mepolizumab treatment		Inclusion: Asthma patients without any biological (antibody-based) treatment but on routine ICS and LABA treatment as part of their normal care. Exclusion criteria are any infections Receives: Drug: Standard inhaled corticosteroids (ICS) and long-acting beta 2 agonists (LABA)
Healthy non-asthmatic control subjects		Exclusion criteria: previous history of lung disease, chronic inflammatory condition, or atopy, or cardiovascular disease. Diagnosed or perceived infection within 3 weeks prior to blood sampling

What is being measured

The primary outcome is the main question the study is designed to answer.

Change in Blood Eosinophil Marker Expression
Quantitative analysis of low-intensity proMBP-positive eosinophil-lineage proxy cells in FFPE blood leukocyte pellet sections
Measured: Baseline, Day 2, and Month 4 after mepolizumab initiation
Change in Blood Basophil Marker Expression
Quantitative analysis of high-intensity proMBP-positive basophil-like cells in FFPE blood leukocyte pellet sections.
Measured: Baseline, Day 2, and Month 4 after mepolizumab initiation
Change in Blood Leukocyte Composition
Relative proportion of low-/mid-intensity proMBP-positive eosinophil-lineage proxy cells within the proMBP panel in FFPE blood leukocyte pellet sections
Measured: Baseline, Day 2, and Month 4 after mepolizumab initiation

Secondary outcomes (3)

Change in Blood T Lymphocyte Marker Expression
Quantitative CD4 Th-axis balance readout in FFPE blood leukocyte pellet sections, expressed as log2(GATA3/T-bet ratio).
Measured: Baseline, Day 2, and Month 4 after mepolizumab initiation
Change in Blood B Lymphocyte Marker Expression
Quantitative B-cell HLA-DR readout in FFPE blood leukocyte pellet sections, expressed as the percentage of HLA-DR-positive cells within the CD19/CD20-gated population.
Measured: Baseline, Day 2, and Month 4 after mepolizumab initiation
Leukocyte Total Cell Counts
Routine clinical laboratory total leukocyte counts in peripheral blood
Measured: Baseline, Day 2, and Month 4 after mepolizumab initiation.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

1 Jan 201918 Dec 2025

First posted19 Jan 2023
Study start1 Jan 2019
Primary completion1 Sep 2025
Study completion18 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 AsthmaStudies of the same condition, open and under way.
More trials run by Region SkaneThe 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: Cross-sectional
Enrolment: 37 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05689931
Sponsor's protocol ID: 1072615
Status last verified: May 2026
First submitted: 15 Dec 2022
Last updated: 5 Nov 2026
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: Yes
FDA-regulated device: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 5 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Blood Leukocyte Profiling in Eosinophilic Type 2 Asthma: Influence of Systemic IL-5 Targeting
ClinicalTrials.gov ID: NCT05689931
Acronym / sponsor ID: 1072615
Conditions: Asthma
Study type: Observational
Recruitment status: Completed
Enrolment: 37 participants (actual)
Lead sponsor: Region SkaneUniversity, hospital or other
Collaborators: Lund University
Study start: 1 Jan 2019 (actual)
Primary completion: 1 Sep 2025 (actual)
Study completion: 18 Dec 2025 (actual)
First posted: 19 Jan 2023 (actual)
Results: Posted 5 Nov 2026

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Observational model: Cohort
Time perspective: Cross-sectional
Number of arms: 4

Arm	Type	Receives
Asthma patients initiating Mepolizumab treatment	–	Biological: Mepolizumab, Drug: Standard inhaled corticosteroids (ICS) and long-acting beta 2 agonists (LABA)Patients will be selected on the standard criteria used to select eligible asthma patients for mepolizumab treatment (i.e. patients with eosinophilic asthma that are not controlled by conventional high dose ICS and LABA etc). All eligible asthma patients may be included. Exclusion criteria: any infection
Asthma patients already on Mepolizumab treatment	–	Biological: Mepolizumab, Drug: Standard inhaled corticosteroids (ICS) and long-acting beta 2 agonists (LABA)Patients that have been selected and given Mepolizumab treatment for > 4 months according to standard eligible and treatment regimen criteria (i.e. patients with eosinophilic asthma that are not controlled by conventional high dose ICS and LABA etc). All eligible asthma patients that have been on Mepolizumab treatment for > 4 weeks will be included. Exclusion criteria: any infections
Asthma patients without Mepolizumab treatment	–	Drug: Standard inhaled corticosteroids (ICS) and long-acting beta 2 agonists (LABA)Inclusion: Asthma patients without any biological (antibody-based) treatment but on routine ICS and LABA treatment as part of their normal care. Exclusion criteria are any infections
Healthy non-asthmatic control subjects	–	–Exclusion criteria: previous history of lung disease, chronic inflammatory condition, or atopy, or cardiovascular disease. Diagnosed or perceived infection within 3 weeks prior to blood sampling

Who may qualify

Ages: 18 to 80 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult, Older adult
Study population: All asthma patients will be recruited at the Department of Allergology and Lung Medicine, Skåne University Hospital (SUS), Lund, Sweden. Healthy control subjects are recruited by local advertisement.

Key inclusion criteria (2 listed)

Clinical diagnosis of asthma (the asthma patient arms)
Eligible for Mepolizumab treatment as per the country-specific prescribing information (the arms with Mepolizumab)

Key exclusion criteria (2 listed)

Any diagnosed infection (all arms)
Previous history of lung disease, chronic inflammatory condition, atopy, or cardiovascular disease. Diagnosed or perceived infection within 3 weeks prior to blood sampling (Healthy non-asthma control subjects)

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
MepolizumabAlso: Mepolizumab (brand name: Nucala)Mepolizumab is administered by subcutaneous injection with guideline recommended patient selection and dosing for treatment of eosinophilic asthma. Accordingly, the Mepolizumab treatment is given as add-on therapy to standard inhaled corticosteroids (ICS) and long-acting beta 2 agonists (LABA)	Biological	Asthma patients already on Mepolizumab treatment, Asthma patients initiating Mepolizumab treatment
Standard inhaled corticosteroids (ICS) and long-acting beta 2 agonists (LABA)Also: ICS and LABARoutine asthma treatment with inhaled corticosteroids (ICS) and long-acting beta 2 agonists (LABA)	Drug	Asthma patients already on Mepolizumab treatment, Asthma patients initiating Mepolizumab treatment, Asthma patients without Mepolizumab treatment

Primary outcome

Change in Blood Eosinophil Marker Expression
Time frame: Baseline, Day 2, and Month 4 after mepolizumab initiation
Quantitative analysis of low-intensity proMBP-positive eosinophil-lineage proxy cells in FFPE blood leukocyte pellet sections
Change in Blood Basophil Marker Expression
Time frame: Baseline, Day 2, and Month 4 after mepolizumab initiation
Quantitative analysis of high-intensity proMBP-positive basophil-like cells in FFPE blood leukocyte pellet sections.
Change in Blood Leukocyte Composition
Time frame: Baseline, Day 2, and Month 4 after mepolizumab initiation
Relative proportion of low-/mid-intensity proMBP-positive eosinophil-lineage proxy cells within the proMBP panel in FFPE blood leukocyte pellet sections

3 secondary outcomes

Change in Blood T Lymphocyte Marker Expression
Time frame: Baseline, Day 2, and Month 4 after mepolizumab initiation
Change in Blood B Lymphocyte Marker Expression
Time frame: Baseline, Day 2, and Month 4 after mepolizumab initiation
Leukocyte Total Cell Counts
Time frame: Baseline, Day 2, and Month 4 after mepolizumab initiation.

Results and safety

Results posted to the registry on 5 Nov 2026, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Group 1: T2-high Asthma Initiating Mepolizumab	5	5
Group 2: T2-high Asthma on Maintenance Mepolizumab	10	10
Group 3: Moderate-severe Asthma Not Eligible for Biologics	11	11
Group 4: Healthy Controls	11	11

Primary outcome: Change in Blood Eosinophil Marker Expression

Time frame: Baseline, Day 2, and Month 4 after mepolizumab initiation. Mean (Full Range). Unit: Cells per section

Measure	Group 1: T2-high Asthma Initiating Mepolizumab n = 5	Group 2: T2-high Asthma on Maintenance Mepolizumab n = 0	Group 3: Moderate-severe Asthma Not Eligible for Biologics n = 0	Group 4: Healthy Controls n = 0
Baseline	274.8 (74 to 490)	–	–	–
Day 2	48.6 (12 to 99)	–	–	–
Month 4	39.2 (1.0 to 63.0)	–	–	–

Population analysed: This outcome was analyzed in Group 1 only, comprising T2-high asthma patients initiating mepolizumab with longitudinal blood leukocyte pellet sampling. Groups 2-4 were not included in this change-from-baseline analysis because they were not sampled longitudinally after mepolizumab initiation.

Primary outcome: Change in Blood Basophil Marker Expression

Time frame: Baseline, Day 2, and Month 4 after mepolizumab initiation. Mean (Full Range). Unit: Cells per section

Measure	Group 1: T2-high Asthma Initiating Mepolizumab n = 5	Group 2: T2-high Asthma on Maintenance Mepolizumab n = 0	Group 3: Moderate-severe Asthma Not Eligible for Biologics n = 0	Group 4: Healthy Controls n = 0
Baseline	52.8 (12 to 125)	–	–	–
Day 2	17.8 (2 to 62)	–	–	–
Month 4	19.8 (5 to 45)	–	–	–

Primary outcome: Change in Blood Leukocyte Composition

Time frame: Baseline, Day 2, and Month 4 after mepolizumab initiation. Mean (Full Range). Unit: Proportion of proMBP panel

Measure	Group 1: T2-high Asthma Initiating Mepolizumab n = 5	Group 2: T2-high Asthma on Maintenance Mepolizumab n = 0	Group 3: Moderate-severe Asthma Not Eligible for Biologics n = 0	Group 4: Healthy Controls n = 0
Baseline	0.0318 (0.0087 to 0.0514)	–	–	–
Day 2	0.0339 (0.0044 to 0.0649)	–	–	–
Month 4	0.0118 (0.0013 to 0.0252)	–	–	–

3 secondary outcomes are reported in the full results.

Adverse events

Time frame: From enrollment through Month 4 follow-up for Group 1; from enrollment through the 1-week post-refill follow-up for Group 2; and during the baseline study visit for Groups 3 and 4. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Group 1: T2-high Asthma Initiating Mepolizumab	0 of 5 (0%)	0 of 5 (0%)	0 of 5
Group 2: T2-high Asthma on Maintenance Mepolizumab	0 of 10 (0%)	0 of 10 (0%)	0 of 10
Group 3: Moderate-severe Asthma Not Eligible for Biologics	0 of 11 (0%)	0 of 11 (0%)	0 of 11
Group 4: Healthy Controls	0 of 11 (0%)	0 of 11 (0%)	0 of 11

Limitations and caveats (from the sponsor): Final enrollment was lower than planned due to COVID-19-related restrictions, post-pandemic delays in restarting clinical research, and reduced clinical use of mepolizumab as other T2-high asthma biologics became more common. The mepolizumab-initiation cohort was therefore small (n=5), limiting statistical power. Results are exploratory.Some originally listed routine hematology outcomes are not reported separately because the final analysis dataset focused on histology-based leukocyte analyses.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 5 Nov 2026.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

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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.

Jonas Erjefält principal investigator

Lund University Hospital

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 Asthma, run by Region Skane at 1 site in Sweden.

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 2 inclusion and 2 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 5 Nov 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 Sweden. 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 5 Nov 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?

Change in Blood Eosinophil Marker Expression (time frame: Baseline, Day 2, and Month 4 after mepolizumab initiation). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05689931.

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 5 Nov 2026.