Atopic AsthmaPhase 2NCT02758548
Determination of Accuracy in Measurement of Total Immunoglobulin E Using a Test Device in Atopic Subjects
A Phase 2 study testing Blood sample and POCT device in people with Atopic Asthma, run by Novartis Pharmaceuticals at 12 sites in 5 countries.
Trial summary
The purpose of this study is to determine the accuracy of the Novel point of care test (POCT) total IgE assay in atopic patients. 120 patients with atopic conditions and approximately 40 healthy subjects will be enrolled. Fingerstick capillary blood samples will be collected and tested in the POCT device. Read more about this study
- Who is it for?
- Ages 6 years and olderHealthy volunteers can take part
- Conditions the study is for
- Atopic Asthma
- What is being tested?
- Blood sample and POCT device
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 193 participants
- Where
- 12 sitesin 5 countries
- Study dates
- Mar 2016to May 2016
- Phase
- Phase 2
- 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 6 years and older
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Subjects who are diagnosed with atopic condition
- Subjects or legal guardians who are able to give informed consent
- Other protocol-defined inclusion criteria may apply Exclusion criteria: atopic patients
- Subjects who have received anti-IgE antibody treatment
- Subjects who have elevated IgE levels for reasons other than allergic conditions
- Other protocol-defined exclusion criteria may apply Inclusion criteria: healthy subjects
- Subjects who are able to give informed consent for participation in the study according to local requirements / law.
Who cannot join
- Subjects who have received anti-IgE antibody treatment
- Subjects with a suspected or confirmed clinical diagnosis of an atopic condition
- Other protocol-defined exclusion criteria may apply
Trial locations and contacts
12 sites in 5 countries.
12 sites in 5 countries
Italy3 sites
Novartis Investigative Site
Padova, PD, 35128
Novartis Investigative Site
Pisa, PI, 56124
Novartis Investigative Site
Roma, RM, 00168
United Kingdom3 sites
Novartis Investigative Site
Bradford, West Yorkshire, BD9 6RJ
Novartis Investigative Site
Chertsey, Surrey, KT16 0PZ
Novartis Investigative Site
Manchester, M23 9QZ
Germany2 sites
Novartis Investigative Site
Hamburg, 20354
Novartis Investigative Site
Lübeck, 23552
Netherlands2 sites
Novartis Investigative Site
Almelo, 7609 PP
Novartis Investigative Site
Harderwijk, Netherlands, 3840 AC
Spain2 sites
Novartis Investigative Site
Sabadell, Barcelona, 08208
Novartis Investigative Site
Valencia, Valencia, 46017
About this study
Official title: A Multicenter Clinical Evaluation Study to Determine the External Site Accuracy of Total Immunoglobulin E Measurement Using a Novel Point of Care Test Device Compared to a Reference Method in Atopic Subjects
The purpose of this study is to determine the accuracy of the Novel point of care test (POCT) total IgE assay in atopic patients.
120 patients with atopic conditions and approximately 40 healthy subjects will be enrolled. Fingerstick capillary blood samples will be collected and tested in the POCT device. Venous samples will be collected and sent to a reference laboratory for measurement of serum total IgE using the reference immunoassay method.
- Conditions
- Atopic Asthma
- Being tested
- Blood sample, POCT device
- Keywords
- Total IgE measurement, Novel Point-of-care test device, atopic conditions, in vitro diagnostic test
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Blood sampleProcedure or surgery
Fingerprick and venous
POCT deviceDevice
Investigational device
| Study group | Role | What they receive |
|---|---|---|
| Capillary Blood Sampling | Other | Capillary blood sampling, collected as two fingerprick samples with POCT device and two venous samples Receives: Procedure: Blood sample; Device: POCT device |
What is being measured
The primary outcome is the main question the study is designed to answer.
Total IgE concentration
Total IgE concentration in capillary blood measured with the POCT device at Day 0 or Day 1 from enrollment.
Total IgE concentration in venous blood measured with the reference method at Day 0 or Day 1 from enrollment.
Measured: Day 0 or Day 1 (Visit 2: Blood sampling)
Secondary outcomes (1)
Device usability questionnaire response
Device usability assessment of the POCT device as per operators at the completion of the study.
Measured: Day 0 or Day 1 (Visit 2: Blood sampling)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 May 2016 (estimated)
- Study startMar 2016
- Primary completionMay 2016
- Study completionMay 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Atopic AsthmaStudies of the same condition, open and under way.
- More trials run by Novartis PharmaceuticalsThe 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 2
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 193 participants (actual)
Sponsor and investigators
- Lead sponsor
- Novartis Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02758548
- Sponsor's protocol ID
- CDIGE0012201
- Status last verified
- Nov 2016
- First submitted
- 15 Mar 2016
- Last updated
- 15 Nov 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Nov 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter Clinical Evaluation Study to Determine the External Site Accuracy of Total Immunoglobulin E Measurement Using a Novel Point of Care Test Device Compared to a Reference Method in Atopic Subjects
- ClinicalTrials.gov ID
- NCT02758548
- Acronym / sponsor ID
- CDIGE0012201
- Conditions
- Atopic Asthma
- Keywords
- Total IgE measurement, Novel Point-of-care test device, atopic conditions, in vitro diagnostic test
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 193 participants (actual)
- Lead sponsor
- Novartis PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- Mar 2016
- Primary completion
- May 2016 (actual)
- Study completion
- May 2016 (actual)
- First posted
- 2 May 2016 (estimated)
- 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.
The purpose of this study is to determine the accuracy of the Novel point of care test (POCT) total IgE assay in atopic patients.
120 patients with atopic conditions and approximately 40 healthy subjects will be enrolled. Fingerstick capillary blood samples will be collected and tested in the POCT device. Venous samples will be collected and sent to a reference laboratory for measurement of serum total IgE using the reference immunoassay method.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Capillary Blood Sampling | Other | Procedure: Blood sample, Device: POCT deviceCapillary blood sampling, collected as two fingerprick samples with POCT device and two venous samples |
Who may qualify
- Ages
- 6 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (7 listed)
- Subjects who are diagnosed with atopic condition
- Subjects or legal guardians who are able to give informed consent
- Other protocol-defined inclusion criteria may apply Exclusion criteria: atopic patients
- Subjects who have received anti-IgE antibody treatment
- Subjects who have elevated IgE levels for reasons other than allergic conditions
Key exclusion criteria (3 listed)
- Subjects who have received anti-IgE antibody treatment
- Subjects with a suspected or confirmed clinical diagnosis of an atopic condition
- Other protocol-defined exclusion criteria may apply
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 |
|---|---|---|
| Blood sampleFingerprick and venous | Procedure or surgery | Capillary Blood Sampling |
| POCT deviceInvestigational device | Device | Capillary Blood Sampling |
Primary outcome
Total IgE concentration
Time frame: Day 0 or Day 1 (Visit 2: Blood sampling)
Total IgE concentration in capillary blood measured with the POCT device at Day 0 or Day 1 from enrollment. Total IgE concentration in venous blood measured with the reference method at Day 0 or Day 1 from enrollment.
1 secondary outcome
Device usability questionnaire response
Time frame: Day 0 or Day 1 (Visit 2: Blood sampling)
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 15 Nov 2016.
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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.
The record lists no contact. Use the official record to reach the sponsor.
12 sites in 5 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Blood sample and POCT device in people with Atopic Asthma, run by Novartis Pharmaceuticals at 12 sites in 5 countries.
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 7 inclusion and 3 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 15 Nov 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 12 sites in Italy, United Kingdom, Germany, Netherlands, Spain. 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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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?
Total IgE concentration (time frame: Day 0 or Day 1 (Visit 2: Blood sampling)). 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 15 Nov 2016.