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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

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 - DIGE0012201

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
NL-OMON
Registry ID
NL-OMON44019
Enrollment
30
Registered
2015-05-13
Start date
2016-03-30
Completion date
Unknown
Last updated
2024-04-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

allergic asthma atopic asthma

Interventions

Study duration: 1-2 weeks. 2 visits of approximately 1 hour. Blood Collection (venapunction): 2x, about 11 ml each time. Finger prick: 2x

Sponsors

Novartis
Lead Sponsor

Eligibility

Age
18 Years to 99 Years

Inclusion criteria

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: 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 outcomes

Primary

MeasureTime frame
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

MeasureTime frame
Secondary endpoints: * Device usability questionnaire.

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)