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

Obstructive Lung Diseases Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT03845257
• Other study ID #: Protocol DG3.0 - 25.06.2018
• Status: Terminated
• Start date: February 14, 2019
• Est. completion date: January 8, 2020

Study information

• Verified date: July 2022
• Source: Heidelberg University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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)

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 14
• Est. completion date: January 8, 2020
• Est. primary completion date: January 8, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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])

Related Conditions & MeSH terms

• Lung Diseases
• Lung Diseases, Obstructive
• Obstructive Lung Diseases
• Pulmonary Disease, Chronic Obstructive

Intervention

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.

Locations

Country	Name	City	State
Australia	Macquarie University Sydney	Sydney	New South Wales
Germany	Division of Clinical Infectious Diseases/Research Center Borstel	Borstel
Germany	Thoraxklinik University Heidelberg	Heidelberg

Sponsors (1)

Lead Sponsor	Collaborator
Heidelberg University

Countries where clinical trial is conducted

Australia,  Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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