AsthmaNCT04377958
Development and Validation of a Serum Biomarker for the Diagnostic Work-up of Asthma
A study testing Serum biomarker testing in people with Asthma and Biomarkers, run by KU Leuven.
Trial summary
Serum samples of asthmatic patients will be screened for serum biomarkers Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Asthma, Biomarkers
- What is being tested?
- Serum biomarker testing
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 117 participants
- Where
- No sites listed yet
- Study dates
- Dec 2016to May 2020
- Phase
- Interventional
- 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 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 18 - 65 years
- physician-diagnosed asthma
Who cannot join
- No clear asthma phenotype
- Presence of other pulmonary diseases (Chronic obstructive pulmonary disease, alfa-1-antitrypsine deficiency emphysema, Immunoglobulin E deficiency, allergic bronchopulmonary aspergillosis)
- > 15 pack years
- No sputum available
- Respiratory infection
- Other inflammatory diseases (Rheumatoid Arthritis, Colitis Ulcerosa)
About this study
Serum samples of asthmatic patients will be screened for serum biomarkers
- Conditions
- Asthma, Biomarkers
- Being tested
- Serum biomarker testing
- Medical subject headings
- Asthma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Serum biomarker testingDiagnostic test
Serum and sputum samples will be collected and biomarkers will be evaluated using ELISA
| Study group | Role | What they receive |
|---|---|---|
| Asthmatics | Other | Asthmatic group from which serum samples will be collected for analysis Receives: Diagnostic Test: Serum biomarker testing |
What is being measured
The primary outcome is the main question the study is designed to answer.
Serum calprotectin
Serum Calprotectin (pg/ml) will be measured in serum samples using a U-plex assay
Measured: Day 1
Secondary outcomes (1)
Sputum calprotectin
Sputum Calprotectin (pg/ml) will be measured in sputum samples using a U-plex assay
Measured: Day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 May 2020
- Study startDec 2016
- Primary completionOct 2017
- Study completionMay 2020
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 N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 117 participants (actual)
Sponsor and investigators
- Lead sponsor
- KU Leuven
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Tatjana Decaesteker, KU Leuven
- Investigators
- Lieven Dupont, Principal investigator, UZ Leuven
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04377958
- Sponsor's protocol ID
- s52549
- Status last verified
- May 2020
- First submitted
- 4 May 2020
- Last updated
- 8 May 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 May 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Development and Validation of a Serum Biomarker for the Diagnostic Work-up of Asthma
- ClinicalTrials.gov ID
- NCT04377958
- Acronym / sponsor ID
- s52549
- Conditions
- Asthma, Biomarkers
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 117 participants (actual)
- Lead sponsor
- KU LeuvenUniversity, hospital or other
- Study start
- Dec 2016 (actual)
- Primary completion
- Oct 2017 (actual)
- Study completion
- May 2020 (actual)
- First posted
- 7 May 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.
Serum samples of asthmatic patients will be screened for serum biomarkers
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Asthmatics | Other | Diagnostic Test: Serum biomarker testingAsthmatic group from which serum samples will be collected for analysis |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 18 - 65 years
- physician-diagnosed asthma
Key exclusion criteria (6 listed)
- No clear asthma phenotype
- Presence of other pulmonary diseases (Chronic obstructive pulmonary disease, alfa-1-antitrypsine deficiency emphysema, Immunoglobulin E deficiency, allergic bronchopulmonary aspergillosis)
- > 15 pack years
- No sputum available
- Respiratory infection
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 |
|---|---|---|
| Serum biomarker testingSerum and sputum samples will be collected and biomarkers will be evaluated using ELISA | Diagnostic test | Asthmatics |
Primary outcome
Serum calprotectin
Time frame: Day 1
Serum Calprotectin (pg/ml) will be measured in serum samples using a U-plex assay
1 secondary outcome
Sputum calprotectin
Time frame: Day 1
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 8 May 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.
Lieven Dupont principal investigator
UZ Leuven
Questions about this trial
What is this clinical trial studying?
A study testing Serum biomarker testing in people with Asthma and Biomarkers, 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 2 inclusion and 6 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 8 May 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.
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?
Serum calprotectin (time frame: Day 1). 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 8 May 2020.