NCT03845257

Brief Summary

Scientific research focuses on "eosinophilic inflammation" as it seems to guide the therapeutic regimen in patients with asthma and COPD. The primary objective of this prospective trial is to evaluate which parameter(s) best reflects eosinophilic inflammation by correlating tissue eosinophils (endobronchial biopsy, protected specimen brush sampling) with FeNO, peripheral blood eosinophils, and eosinophils in the bronchoalveolar lavage of patients with obstructive pulmonary disease.

Trial Health

60
Monitor

Trial Health Score

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

Enrollment
14

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Feb 2019

Shorter than P25 for all trials

Geographic Reach
2 countries

3 active sites

Status
terminated

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

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 14, 2019

Completed
Same day until next milestone

Study Start

First participant enrolled

February 14, 2019

Completed
5 days until next milestone

First Posted

Study publicly available on registry

February 19, 2019

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 8, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 8, 2020

Completed
Last Updated

July 7, 2022

Status Verified

July 1, 2022

Enrollment Period

11 months

First QC Date

February 14, 2019

Last Update Submit

July 4, 2022

Conditions

Obstructive Lung Diseases

Outcome Measures

Primary Outcomes (1)

  • Assessment of eosinophilic inflammation by correlating tissue eosinophilia with eosinophil count in blood/BAL and FeNO measurement.

    Correlation of FeNO, blood eosinophils, bronchoalveolar lavage findings and bronchial epithelium histopathology in patients with chronic obstructive pulmonary disease and asthma

    18 months

Study Arms (2)

Patients with COPD

The following parameters are to be evaluated: * Blood eosinophils * FeNO * Eosinophils in bronchoalveolar lavage * Tissue eosinophilia (protected specimen brush sampling, endobronchial biopsy)

Diagnostic Test: Blood sampling, FeNO, bronchoalveolar lavage, bronchoscopic tissue sampling

Patients with asthma

The following parameters are to be evaluated: * Blood eosinophils * FeNO * Eosinophils in bronchoalveolar lavage * Tissue eosinophilia (protected specimen brush sampling, endobronchial biopsy)

Diagnostic Test: Blood sampling, FeNO, bronchoalveolar lavage, bronchoscopic tissue sampling

Interventions

Blood sampling, FeNO, bronchoalveolar lavage, bronchoscopic tissue samplingDIAGNOSTIC_TEST

Blood sampling (eosinophil count; eosinophilia is defined as \>300/µl (or \>150/µl during oral glucocorticosteroid treatment); FeNO: Measurement of fractional nitric oxide (NO) concentration in exhaled breath; Bronchoscopy: BAL: total leukocyte counts and leukocyte differential counts including eosinophils, PSB sampling: eosinophil count/100 cells, endobrochial biopsy: tissue eosinophil count/100 cells.

Patients with COPDPatients with asthma

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients with diagnosis of COPD or asthma (according to the guidelines)

You may qualify if:

  • Patients with diagnosis of COPD or asthma (according to the guidelines)
  • Age \>18 years
  • Indication for bronchoscopy for medical reasons (not study-related)
  • Ability to provide informed consent

You may not qualify if:

  • paO2 \<60 mmHg on 4L 02 /min, paCO2 \> 55 mmHg on room air
  • FEV1 \<20%
  • Pulmonary infection or exacerbation within the last 4 weeks
  • Additional pulmonary diseases (pneumonia, lung cancer, tuberculosis, interstitial lung disease)
  • Contraindication for BAL, PSB sampling or endobronchial biopsy
  • Current use of anticoagulants that can not be stopped for bronchoscopy
  • Heart failure with left ventricular ejection fraction \<30%
  • Myocardial infarction in previous 6 months
  • Significant pulmonary hypertension (PAPS \>45 mmHg, right heart failure \[echocardiography\] and/or PAPm \>35 mmHg \[right heart catheter\])

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Macquarie University Sydney

Sydney, New South Wales, Australia

Location

Division of Clinical Infectious Diseases/Research Center Borstel

Borstel, Germany

Location

Thoraxklinik University Heidelberg

Heidelberg, 69126, Germany

Location

MeSH Terms

Conditions

Lung Diseases, Obstructive

Interventions

Blood Specimen CollectionFractional Exhaled Nitric Oxide Testing

Condition Hierarchy (Ancestors)

Lung DiseasesRespiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Specimen HandlingClinical Laboratory TechniquesDiagnostic Techniques and ProceduresDiagnosisPuncturesSurgical Procedures, OperativeInvestigative TechniquesBreath Tests

Study Officials

  • Daniela Gompelmann

    Thoraxklinik University Heidelberg

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Daniela Gompelmann, MD

Study Record Dates

First Submitted

February 14, 2019

First Posted

February 19, 2019

Study Start

February 14, 2019

Primary Completion

January 8, 2020

Study Completion

January 8, 2020

Last Updated

July 7, 2022

Record last verified: 2022-07

Locations

AU(1)DE(2)