Back to resultsDevelopment and Validation of a Serum Biomarker for the Diagnostic Work-up of Asthma
Primary Purpose
Asthma, Biomarkers
Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Serum biomarker testing
Sponsored by
About this trial
This is an interventional diagnostic trial for Asthma
Eligibility Criteria
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)
Sites / Locations
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
Asthmatics
Arm Description
Asthmatic group from which serum samples will be collected for analysis
Outcomes
Primary Outcome Measures
Serum calprotectin
Serum Calprotectin (pg/ml) will be measured in serum samples using a U-plex assay
Secondary Outcome Measures
Sputum calprotectin
Sputum Calprotectin (pg/ml) will be measured in sputum samples using a U-plex assay
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04377958
Brief Title
Development and Validation of a Serum Biomarker for the Diagnostic Work-up of Asthma
Official Title
Development and Validation of a Serum Biomarker for the Diagnostic Work-up of Asthma
Study Type
Interventional
2. Study Status
Record Verification Date
May 2020
Overall Recruitment Status
Completed
Study Start Date
December 2016 (Actual)
Primary Completion Date
October 2017 (Actual)
Study Completion Date
May 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
KU Leuven
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
Serum samples of asthmatic patients will be screened for serum biomarkers
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Asthma, Biomarkers
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
117 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Asthmatics
Arm Type
Other
Arm Description
Asthmatic group from which serum samples will be collected for analysis
Intervention Type
Diagnostic Test
Intervention Name(s)
Serum biomarker testing
Intervention Description
Serum and sputum samples will be collected and biomarkers will be evaluated using ELISA
Primary Outcome Measure Information:
Title
Serum calprotectin
Description
Serum Calprotectin (pg/ml) will be measured in serum samples using a U-plex assay
Time Frame
Day 1
Secondary Outcome Measure Information:
Title
Sputum calprotectin
Description
Sputum Calprotectin (pg/ml) will be measured in sputum samples using a U-plex assay
Time Frame
Day 1
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Lieven Dupont
Organizational Affiliation
UZ Leuven
Official's Role
Principal Investigator
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Development and Validation of a Serum Biomarker for the Diagnostic Work-up of Asthma
We'll reach out to this number within 24 hrs