NCT04377958

Brief Summary

Serum samples of asthmatic patients will be screened for serum biomarkers

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
117

participants targeted

Target at P50-P75 for not_applicable asthma

Timeline
Completed

Started Dec 2016

Typical duration for not_applicable asthma

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2016

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2017

Completed
2.6 years until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2020

Completed
3 days until next milestone

First Submitted

Initial submission to the registry

May 4, 2020

Completed
3 days until next milestone

First Posted

Study publicly available on registry

May 7, 2020

Completed
Last Updated

May 8, 2020

Status Verified

May 1, 2020

Enrollment Period

10 months

First QC Date

May 4, 2020

Last Update Submit

May 6, 2020

Conditions

AsthmaBiomarkers

Outcome Measures

Primary Outcomes (1)

  • Serum calprotectin

    Serum Calprotectin (pg/ml) will be measured in serum samples using a U-plex assay

    Day 1

Secondary Outcomes (1)

  • Sputum calprotectin

    Day 1

Study Arms (1)

Asthmatics

OTHER

Asthmatic group from which serum samples will be collected for analysis

Diagnostic Test: Serum biomarker testing

Interventions

Serum biomarker testingDIAGNOSTIC_TEST

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

Asthmatics

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • years
  • physician-diagnosed asthma

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Asthma

Condition Hierarchy (Ancestors)

Bronchial DiseasesRespiratory Tract DiseasesLung Diseases, ObstructiveLung DiseasesRespiratory HypersensitivityHypersensitivity, ImmediateHypersensitivityImmune System Diseases

Study Officials

  • Lieven Dupont

    UZ Leuven

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

May 4, 2020

First Posted

May 7, 2020

Study Start

December 1, 2016

Primary Completion

October 1, 2017

Study Completion

May 1, 2020

Last Updated

May 8, 2020

Record last verified: 2020-05

Data Sharing

IPD Sharing
Will not share