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Development 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
KU Leuven
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Asthma

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

    First Posted
    May 4, 2020
    Last Updated
    May 6, 2020
    Sponsor
    KU Leuven
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    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

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