Clinical trial NCT02758548: Determination of Accuracy in Measurement of Total Immunoglobulin E Using a Test Device in Atopic Subjects
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Atopic Asthma
Keywords: Total IgE measurement
Novel Point-of-care test device
atopic conditions
in vitro diagnostic test
Lead sponsor: Novartis
Sponsor class: INDUSTRY
First posted: 2016-05-02
Enrollment: 193
Sex: ALL
Minimum age (years): 6
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief 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. Venous samples will be collected and sent to a reference laboratory for measurement of serum total IgE using the reference immunoassay method.


Eligibility criteria: Inclusion criteria: atopic patients

* 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.

Exclusion criteria: healthy subjects

* 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

Primary outcomes:
measure: Total IgE concentration
timeFrame: Day 0 or Day 1 (Visit 2: Blood sampling)
Secondary outcomes:
measure: Device usability questionnaire response
timeFrame: Day 0 or Day 1 (Visit 2: Blood sampling)
Other outcomes:
Locations:
city: Hamburg
country: Germany
facility: Novartis Investigative Site
city: Lübeck
country: Germany
facility: Novartis Investigative Site
city: Padova
country: Italy
facility: Novartis Investigative Site
state: PD
city: Pisa
country: Italy
facility: Novartis Investigative Site
state: PI
city: Roma
country: Italy
facility: Novartis Investigative Site
state: RM
city: Almelo
country: Netherlands
facility: Novartis Investigative Site
city: Harderwijk
country: Netherlands
facility: Novartis Investigative Site
city: Sabadell
country: Spain
facility: Novartis Investigative Site
state: Barcelona
city: Valencia
country: Spain
facility: Novartis Investigative Site
state: Comunidad Valenciana
city: Chertsey
country: United Kingdom
facility: Novartis Investigative Site
state: Surrey
city: Bradford
country: United Kingdom
facility: Novartis Investigative Site
state: West Yorkshire
city: Manchester
country: United Kingdom
facility: Novartis Investigative Site
Study officials:
References: