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

Not Applicable

Completed

• Conditions: Asthma; Biomarkers
• Interventions: Diagnostic Test: Serum biomarker testing

• Registration Number: NCT04377958
• Lead Sponsor: KU Leuven

Brief Summary

Serum samples of asthmatic patients will be screened for serum biomarkers

Detailed Description

Not available

Study Timeline

• Study Start: 2016-12
• Primary Completion: 2017-10
• Status Verified: 2020-05
• Study Completion: 2020-05
• Study First Submitted: 2020-05-04
• Study First Submitted QC: 2020-05-04
• Last Update Submitted: 2020-05-06
• Study First Posted: 2020-05-07
• Last Update Posted: 2020-05-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 117

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

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Asthmatics	Serum biomarker testing	Asthmatic group from which serum samples will be collected for analysis

Primary Outcome Measures

Name	Time	Method
Serum calprotectin	Day 1	Serum Calprotectin (pg/ml) will be measured in serum samples using a U-plex assay

Secondary Outcome Measures

Name	Time	Method
Sputum calprotectin	Day 1	Sputum Calprotectin (pg/ml) will be measured in sputum samples using a U-plex assay