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

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT04377958

Enrollment

117

Registered

2020-05-07

Start date

2016-12-31

Completion date

2020-05-31

Last updated

2020-05-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Asthma, Biomarkers

Brief summary

Serum samples of asthmatic patients will be screened for serum biomarkers

Interventions

DIAGNOSTIC_TESTSerum biomarker testing

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

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

DIAGNOSTIC

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 65 Years

Healthy volunteers

Yes

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)

Design outcomes

Primary

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

Secondary

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

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026