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NCT04377958 Clinical Trial

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

Asthma Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT04377958
Other study ID # s52549
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date December 2016
Est. completion date May 2020

Study information
Verified date May 2020
Source KU Leuven
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Serum samples of asthmatic patients will be screened for serum biomarkers

Recruitment information / eligibility
Status Completed
Enrollment 117
Est. completion date May 2020
Est. primary completion date October 2017
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 65 Years
Eligibility 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)

Study Design

Related Conditions & MeSH terms

Intervention

Diagnostic Test:
• Serum biomarker testing
Serum and sputum samples will be collected and biomarkers will be evaluated using ELISA

Locations
Country Name City State
n/a

Sponsors (1)
Lead Sponsor Collaborator
KU Leuven

Outcome
Type Measure Description Time frame Safety issue
Primary Serum calprotectin Serum Calprotectin (pg/ml) will be measured in serum samples using a U-plex assay Day 1
Secondary Sputum calprotectin Sputum Calprotectin (pg/ml) will be measured in sputum samples using a U-plex assay Day 1
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