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

Heidelberg University

Status: Terminated

Conditions: Obstructive Lung Diseases

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

Study type: Observational

Funder types: Other

Identifiers

NCT03845257

Protocol DG3.0 - 25.06.2018

Details and patient eligibility

About

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.

Full 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)

Enrollment: 14 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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])

Trial design

14 participants in 2 patient groups

Patients with COPD

Description:

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

Treatment:

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

Patients with asthma

Description:

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

Treatment:

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