Correlation of FeNO, Blood Eosinophils, Bronchoalveolar Lavage Findings and Bronchial Epithelium Histopathology in Patients With Chronic Obstructive Pulmonary Disease and Asthma

July 4, 2022 updated by: Daniela Gompelmann, Heidelberg University
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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Detailed Description

This is a multicenter prospective trial. Enrollment will continue until 150 patients with chronic obstructive pulmonary disease and 50 patients with severe asthma have been entered into this trial and have completed bronchoscopic evaluation. In this trial, the following parameters are to be evaluated:

  • Blood eosinophils (absolute and relative)
  • FeNO
  • Eosinophils in bronchoalveolar lavage
  • Tissue eosinophilia (protected specimen brush sampling, endobronchial biopsy)

Study Type

Observational

Enrollment (Actual)

14

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Australia
    • New South Wales
      • Sydney, New South Wales, Australia
        • Macquarie University Sydney
  • Germany
      • Borstel, Germany
        • Division of Clinical Infectious Diseases/Research Center Borstel
      • Heidelberg, Germany, 69126
        • Thoraxklinik University Heidelberg

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

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

Description

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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])

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
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
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 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
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Assessment of eosinophilic inflammation by correlating tissue eosinophilia with eosinophil count in blood/BAL and FeNO measurement.
Time Frame: 18 months
Correlation of FeNO, blood eosinophils, bronchoalveolar lavage findings and bronchial epithelium histopathology in patients with chronic obstructive pulmonary disease and asthma
18 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Heidelberg University

Investigators

  • Principal Investigator: Daniela Gompelmann, Thoraxklinik University Heidelberg

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

February 14, 2019

Primary Completion (ACTUAL)

January 8, 2020

Study Completion (ACTUAL)

January 8, 2020

Study Registration Dates

First Submitted

February 14, 2019

First Submitted That Met QC Criteria

February 14, 2019

First Posted (ACTUAL)

February 19, 2019

Study Record Updates

Last Update Posted (ACTUAL)

July 7, 2022

Last Update Submitted That Met QC Criteria

July 4, 2022

Last Verified

July 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Protocol DG3.0 - 25.06.2018

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Obstructive Lung Diseases

Clinical Trials on Blood sampling, FeNO, bronchoalveolar lavage, bronchoscopic tissue sampling

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Indonesia

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe