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

Terminated

• Conditions: Obstructive Lung Diseases
• Interventions: Diagnostic Test: Blood sampling, FeNO, bronchoalveolar lavage, bronchoscopic tissue sampling

• Registration Number: NCT03845257
• Lead Sponsor: 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.

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 Timeline

• Study Start: 2019-02-14
• Study First Submitted: 2019-02-14
• Study First Submitted QC: 2019-02-14
• Study First Posted: 2019-02-19
• Primary Completion: 2020-01-08
• Study Completion: 2020-01-08
• Status Verified: 2022-07
• Last Update Submitted: 2022-07-04
• Last Update Posted: 2022-07-07

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 14

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Patients with asthma	Blood sampling, FeNO, bronchoalveolar lavage, bronchoscopic tissue sampling	The following parameters are to be evaluated: * Blood eosinophils * FeNO * Eosinophils in bronchoalveolar lavage * Tissue eosinophilia (protected specimen brush sampling, endobronchial biopsy)
Patients with COPD	Blood sampling, FeNO, bronchoalveolar lavage, bronchoscopic tissue sampling	The following parameters are to be evaluated: * Blood eosinophils * FeNO * Eosinophils in bronchoalveolar lavage * Tissue eosinophilia (protected specimen brush sampling, endobronchial biopsy)

Primary Outcome Measures

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

Trial Locations

Locations (3)

Macquarie University Sydney; 🇦🇺 Sydney, New South Wales, Australia

Thoraxklinik University Heidelberg; 🇩🇪 Heidelberg, Germany

Division of Clinical Infectious Diseases/Research Center Borstel; 🇩🇪 Borstel, Germany