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

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ClinicalTrials.gov Identifier: NCT03845257
Recruitment Status : Recruiting
First Posted : February 19, 2019
Last Update Posted : February 19, 2019
Sponsor:
Information provided by (Responsible Party):
Daniela Gompelmann, Heidelberg University

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.

Condition or disease Intervention/treatment
Obstructive Lung Diseases Diagnostic Test: Blood sampling, FeNO, bronchoalveolar lavage, bronchoscopic tissue sampling

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)

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Study Type : Observational
Estimated Enrollment : 200 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Correlation of FeNO, Blood Eosinophils, Bronchoalveolar Lavage Findings and Bronchial Epithelium Histopathology in Patients With Chronic Obstructive Pulmonary Disease and Asthma
Estimated Study Start Date : February 14, 2019
Estimated Primary Completion Date : August 31, 2020
Estimated Study Completion Date : August 31, 2020

Resource links provided by the National Library of Medicine


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.




Primary Outcome Measures :
  1. 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



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients with diagnosis of COPD or asthma (according to the guidelines)
Criteria

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])

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03845257


Contacts
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Contact: Daniela Gompelmann 004962213968087 daniela.gompelmann@directbox.com

Locations
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Australia, New South Wales
Macquarie University Sydney Not yet recruiting
Sydney, New South Wales, Australia
Contact: Alvin Ing         
Germany
Division of Clinical Infectious Diseases/Research Center Borstel Not yet recruiting
Borstel, Germany
Contact: Jan Heyckendorf         
Thoraxklinik University Heidelberg Recruiting
Heidelberg, Germany, 69126
Contact: Daniela Gompelmann         
Sponsors and Collaborators
Heidelberg University
Investigators
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Principal Investigator: Daniela Gompelmann Thoraxklinik University Heidelberg

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Responsible Party: Daniela Gompelmann, Daniela Gompelmann, MD, Heidelberg University
ClinicalTrials.gov Identifier: NCT03845257     History of Changes
Other Study ID Numbers: Protocol DG3.0 - 25.06.2018
First Posted: February 19, 2019    Key Record Dates
Last Update Posted: February 19, 2019
Last Verified: February 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Lung Diseases
Lung Diseases, Obstructive
Pulmonary Disease, Chronic Obstructive
Respiratory Tract Diseases