Determination of Accuracy in Measurement of Total Immunoglobulin E Using a Test Device in Atopic Subjects

Atopic Asthma Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02758548
• Other study ID #: CDIGE0012201
• Status: Completed
• Phase: Phase 2
• First received: March 15, 2016
• Last updated: November 13, 2016
• Start date: March 2016
• Est. completion date: May 2016

Study information

• Verified date: November 2016
• Source: Novartis
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Federal Institute for Drugs and Medical Devices (BfArM)
• Study type: Interventional

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 193
• Est. completion date: May 2016
• Est. primary completion date: May 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 6 Years and older

Eligibility

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

Study Design

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Atopic Asthma

Intervention

Procedure:
• Blood sample
Fingerprick and venous

Device:
• POCT device
Investigational device

Locations

Country	Name	City	State
Germany	Novartis Investigative Site	Hamburg
Germany	Novartis Investigative Site	Lübeck
Italy	Novartis Investigative Site	Padova	PD
Italy	Novartis Investigative Site	Pisa	PI
Italy	Novartis Investigative Site	Roma	RM
Netherlands	Novartis Investigative Site	Almelo
Netherlands	Novartis Investigative Site	Harderwijk
Spain	Novartis Investigative Site	Sabadell	Barcelona
Spain	Novartis Investigative Site	Valencia	Comunidad Valenciana
United Kingdom	Novartis Investigative Site	Bradford	West Yorkshire
United Kingdom	Novartis Investigative Site	Chertsey	Surrey
United Kingdom	Novartis Investigative Site	Manchester

Sponsors (1)

Lead Sponsor	Collaborator
Novartis Pharmaceuticals

Countries where clinical trial is conducted

Germany,  Italy,  Netherlands,  Spain,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Day 0 or Day 1 (Visit 2: Blood sampling)	No
Secondary	Device usability questionnaire response	Device usability assessment of the POCT device as per operators at the completion of the study.	Day 0 or Day 1 (Visit 2: Blood sampling)	No