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
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.
Investigators
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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