Development and Validation of a Serum Biomarker for the Diagnostic Work-up of Asthma

NCT ID: NCT04377958

Last Updated: 2020-05-08

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

117 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-12-31

Study Completion Date

2020-05-31

Brief Summary

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Serum samples of asthmatic patients will be screened for serum biomarkers

Detailed Description

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Conditions

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Asthma Biomarkers

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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Asthmatics

Asthmatic group from which serum samples will be collected for analysis

Group Type OTHER

Serum biomarker testing

Intervention Type DIAGNOSTIC_TEST

Serum and sputum samples will be collected and biomarkers will be evaluated using ELISA

Interventions

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Serum biomarker testing

Serum and sputum samples will be collected and biomarkers will be evaluated using ELISA

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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Inclusion Criteria

* 18 - 65 years
* physician-diagnosed asthma

Exclusion Criteria

* No clear asthma phenotype
* Presence of other pulmonary diseases (Chronic obstructive pulmonary disease, alfa-1-antitrypsine deficiency emphysema, Immunoglobulin E deficiency, allergic bronchopulmonary aspergillosis)
* \> 15 pack years
* No sputum available
* Respiratory infection
* Other inflammatory diseases (Rheumatoid Arthritis, Colitis Ulcerosa)
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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KU Leuven

OTHER

Sponsor Role lead

Responsible Party

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Tatjana Decaesteker

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Lieven Dupont

Role: PRINCIPAL_INVESTIGATOR

UZ Leuven

Other Identifiers

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s52549

Identifier Type: -

Identifier Source: org_study_id

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