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Clinical Trials/NL-OMON44019
NL-OMON44019
Completed
Not Applicable

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

ovartis0 sites30 target enrollmentTBD

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
allergic asthma
Sponsor
ovartis
Enrollment
30
Status
Completed
Last Updated
2 years ago

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
TBD
End Date
TBD
Last Updated
2 years ago
Study Type
Observational invasive

Investigators

Sponsor
ovartis

Eligibility 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 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.

Outcomes

Primary Outcomes

Not specified

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