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Completed

NCT Number: NCT02758548

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

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Key information

Conditions

Atopic Asthma

Age range

6 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Novartis Investigative Site, Hamburg, Germany

Loading trial locations.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Blood sample

Procedure

Fingerprick and venous

POCT device

Device

Investigational device

Primary outcomes

  1. 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.

Secondary outcomes

  1. Device usability questionnaire response

    Time frame: Day 0 or Day 1 (Visit 2: Blood sampling)

    Device usability assessment of the POCT device as per operators at the completion of the study.

Sponsors and collaborators

Lead sponsor

Novartis Pharmaceuticals

Industry

Registry information

Official study 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

Important dates

Study start
2016
Primary completion
2016
Study completion
2016
First posted
May 2, 2016
Registry last updated
Nov 15, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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