AsthmaPhase 4NCT04412044
Effect of Anti-interleukin 5 (IL5) Therapy on Sputum Cells and Cytokines
A Phase 4 study testing Mepolizumab Injection [Nucala] in people with Asthma, run by KU Leuven.
Trial summary
22 asthmatics, in which mepolizumab was to be started, gave permission for inclusion and were followed up prospectively. Clinical and lung functional data, sputum analyses and cytokine measurements were analyzed. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Asthma
- What is being tested?
- Mepolizumab Injection [Nucala]
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 22 participants
- Where
- No sites listed yet
- Study dates
- 1 Sep 2016to 1 Mar 2019
- Phase
- Phase 4
- Are there results?
- None posted in the registry
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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- FEV1 < 80% in the last 12 months
- use of high dose inhaled corticosteroids (ICS) in combination with other additional medication or continuous use of oral corticosteroids (OCS)
- at least 2 exacerbations in the last 12 months
- at least 300 blood eosinophils/µl once in the last 12 months and at the time of inclusion
- Anti-IL5 treatment prescribed by the physician
Who cannot join
- Not completing all visits
About this study
22 asthmatics, in which mepolizumab was to be started, gave permission for inclusion and were followed up prospectively. Clinical and lung functional data, sputum analyses and cytokine measurements were analyzed.
- Conditions
- Asthma
- Being tested
- Mepolizumab Injection [Nucala]
- Medical subject headings
- Asthma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mepolizumab Injection [Nucala]Drug
Also called Anti-IL5 treatment
Patients receive monthly injection with 100 mg mepolizumab
| Study group | Role | What they receive |
|---|---|---|
| Asthmatics | Experimental | Patients receive anti-IL5 treatment as part of their prescribed routine. Immunological and clinical parameters will be evaluated at the start of the treatment and after 6 months of treatment Receives: Drug: Mepolizumab Injection [Nucala] |
What is being measured
The primary outcome is the main question the study is designed to answer.
Airway inflammation
Bronchial airway inflammation. Differential cell count will be performed on sputum samples, determining eosinophilic (>3% eosinophils, <61% neutrophils), neutrophilic (<3% eosinophils and >61% neutrophils), pauci-granulocytic (<3% eosinophils and <61% neutrophils) and mixed granulocytic airway inflammation (>3% eosinophils and >61% neutrophils).
Measured: Day 1 and after 6 months
Change in Forced Expiratory Volume in 1 seconds (FEV1)
The forced expiratory Volume in 1 second will be measured using spirometry
Measured: Day 1 and after 6 months
Secondary outcomes (4)
Cytokine pattern in the airways
Cytokines concentrations (pg/ml) will also be determined in sputum supernatant using a U-plex assay.
Measured: Day 1 and after 6 months
Cytokine pattern in the bloodstream
Cytokines concentrations (pg/ml) will also be determined in serum using a U-plex assay.
Measured: Day 1 and after 6 months
Change in asthma control
Asthma control will be determined using the Asthma Control Questionnaire (ACQ-6), including 6 questions. Each question will be scored from 0-6 and added together. This final score will be divided by the number of questions. If ACQ-6 < 0.75 = controlled asthma, ACQ-6 from 0.75-1.5 = partly controlled asthma and ACQ-6 > 1.5 = uncontrolled asthma.
Measured: Day 1 and after 6 months
Biomarkers for airway inflammation
Fraction exhaled Nitric Oxid (FeNO) will be used as biomarker for eosinophilic airway inflammation. FeNO < 25 ppb = eosinophilic inflammation less likely, FeNO between 25 and 50 ppm = need further interpretation with additional clinical information, FeNO > 50 ppm = indication of eosinophilic airway inflammation (according to the American Thoracic Society guidelines)
Measured: Day 1 and after 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jun 2020
- Study start1 Sep 2016
- Primary completion1 May 2018
- Study completion1 Mar 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AsthmaStudies of the same condition, open and under way.
- More trials run by KU LeuvenThe 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
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 22 participants (actual)
Sponsor and investigators
- Lead sponsor
- KU Leuven
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Tatjana Decaesteker, KU Leuven
- Investigators
- Tatjana Decaesteker, Principal investigator, KU Leuven
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04412044
- Sponsor's protocol ID
- s58608
- Status last verified
- May 2020
- First submitted
- 28 May 2020
- Last updated
- 2 Jun 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Jun 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Anti-interleukin 5 (IL5) Therapy on Sputum Cells and Cytokines
- ClinicalTrials.gov ID
- NCT04412044
- Acronym / sponsor ID
- s58608
- Conditions
- Asthma
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 22 participants (actual)
- Lead sponsor
- KU LeuvenUniversity, hospital or other
- Study start
- 1 Sep 2016 (actual)
- Primary completion
- 1 May 2018 (actual)
- Study completion
- 1 Mar 2019 (actual)
- First posted
- 2 Jun 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
22 asthmatics, in which mepolizumab was to be started, gave permission for inclusion and were followed up prospectively. Clinical and lung functional data, sputum analyses and cytokine measurements were analyzed.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Asthmatics | Experimental | Drug: Mepolizumab Injection [Nucala]Patients receive anti-IL5 treatment as part of their prescribed routine. Immunological and clinical parameters will be evaluated at the start of the treatment and after 6 months of treatment |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (5 listed)
- FEV1 < 80% in the last 12 months
- use of high dose inhaled corticosteroids (ICS) in combination with other additional medication or continuous use of oral corticosteroids (OCS)
- at least 2 exacerbations in the last 12 months
- at least 300 blood eosinophils/µl once in the last 12 months and at the time of inclusion
- Anti-IL5 treatment prescribed by the physician
Key exclusion criteria (1 listed)
- Not completing all visits
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 |
|---|---|---|
| Mepolizumab Injection [Nucala]Also: Anti-IL5 treatmentPatients receive monthly injection with 100 mg mepolizumab | Drug | Asthmatics |
Primary outcome
Airway inflammation
Time frame: Day 1 and after 6 months
Bronchial airway inflammation. Differential cell count will be performed on sputum samples, determining eosinophilic (>3% eosinophils, <61% neutrophils), neutrophilic (<3% eosinophils and >61% neutrophils), pauci-granulocytic (<3% eosinophils and <61% neutrophils) and mixed granulocytic airway inflammation (>3% eosinophils and >61% neutrophils).
Change in Forced Expiratory Volume in 1 seconds (FEV1)
Time frame: Day 1 and after 6 months
The forced expiratory Volume in 1 second will be measured using spirometry
4 secondary outcomes
Cytokine pattern in the airways
Time frame: Day 1 and after 6 months
Cytokine pattern in the bloodstream
Time frame: Day 1 and after 6 months
Change in asthma control
Time frame: Day 1 and after 6 months
Biomarkers for airway inflammation
Time frame: Day 1 and after 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jun 2020.
- Individual participant dataSharing planned: No
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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.
Tatjana Decaesteker principal investigator
KU Leuven
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Mepolizumab Injection [Nucala] in people with Asthma, run by KU Leuven.
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 5 inclusion and 1 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 2 Jun 2020. Status can change between updates, so confirm with the study contact before making plans.
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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Airway inflammation (time frame: Day 1 and after 6 months). The study lists 2 primary outcomes in all. 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 2 Jun 2020.