The purpose of this study is to determine the accuracy of the point-of-care IgE assay in atopic patients and healthy subjects. The POCT results will be compared to a reference immunoassay method for measuring this analyte.It intends to use this new…
ID
Source
Brief title
Condition
- Bronchial disorders (excl neoplasms)
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Primary endpoints:
* Total IgE concentration in capillary blood measured with the POCT device.
* Total IgE concentration in venous blood measured with the reference method.
Secondary outcome
Secondary endpoints:
* Device usability questionnaire.
Background summary
In asthma, increased serum IgE levels are associated with moderate-to-severe
disease and often represent difficult-to-treat cases. Serum total IgE levels
are measured as part of the clinical assessment of this patient population to
determine the best treatment option for individuals.
Novartis Pharmaceuticals has developed a new method with a new device for
measuring the total amount of IgE in the blood. The new method involves testing
a drop of blood on an office-based instrument that will give results within a
few minutes of taking the blood sample. Once approved, this new method of
measurement will allow the diagnosis and treatment of patients with allergic
conditions to be made sooner than with current laboratory tests.
Study objective
The purpose of this study is to determine the accuracy of the point-of-care IgE
assay in atopic patients and healthy subjects. The POCT results will be
compared to a reference immunoassay method for measuring this analyte.
It intends to use this new method in everyday practice making diagnosis faster,
easier, less stressful, moreover (fingerstick versus venapuncture), resulting
in improved clinical treatment of atopic patients.
Study design
This multi-centre study will enroll approximately 120 patients with atopic
conditions and approximately 40 healthy subjects (In Netherlands 30 adult
atopic patients). Subjects enrolled in this study will not receive any study
medication nor have any change in their current treatment as a result of their
participation.
Subjects will attend for a screening visit (visit 1) and, if eligible to be
enrolled, for a blood sampling visit (visit 2).
At the blood sampling visit (Visit 2), all subjects will have two fingerprick
samples of blood tested using the POCT device and two venous blood samples
collected. One venous blood sample will be shipped to the reference laboratory,
and the other venous blood sample will be stored as plasma (a) in case repeat
testing of total IgE concentration is required, and (b) to be used in the
development of future total IgE and other related assays.
Intervention
Study duration: 1-2 weeks. 2 visits of approximately 1 hour.
Blood Collection (venapunction): 2x, about 11 ml each time.
Finger prick: 2x
Study burden and risks
The risks associated with taking part in this study are possible side effects
due to taking blood samples.
The risks of taking blood samples may include fainting, pain and/or bruising.
Rarely, there may be a small blood clot or infection where the needle punctures
the skin.
The finger prick testing may result in bruising or risk of infection in the
fingertip.
Raapopseweg 1
Arnhem 6824 DP
NL
Raapopseweg 1
Arnhem 6824 DP
NL
Listed location countries
Age
Inclusion criteria
Inclusion criteria for patients:
1. Male or female subjects who are aged *18 years.
2. Subjects who are diagnosed with atopic asthma or other atopic condition for a minimum of 6 months prior to study entry. There should be documented evidence of sensitization to one or more specific allergens.;Inclusion criteria for healthy volunteers: N/A for the Netherlands. Besides, adults only (minimum age of 18) will be included in the Netherlands.
Exclusion criteria
Exclusion criteria for patients:
1. Subjects who have received treatment with omalizumab or other anti-IgE antibody treatment in the past 6 months.
2. Subjects who have elevated serum IgE levels for reasons other than allergic conditions (e.g., parasite infections, hyperimmunoglobulin E syndrome, Wiskott-Aldrich syndrome, or bronchopulmonary aspergillosis).;Exclusion criteria for healthy volunteers: N/A for the Netherlands.
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL52478.028.15 |