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

Study Overview
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Brief Summary
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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
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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)

Official Title
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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

Conditions
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Obstructive Lung Diseases

Intervention / Treatment
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* Diagnostic Test: Blood sampling, FeNO, bronchoalveolar lavage, bronchoscopic tissue sampling


Participation Criteria
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Eligibility Criteria
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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])

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Patients with COPD<br>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<br>* 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.<br>|
| Patients with asthma<br>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<br>* 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.<br>|

What is the study measuring?
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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. | Correlation of FeNO, blood eosinophils, bronchoalveolar lavage findings and bronchial epithelium histopathology in patients with chronic obstructive pulmonary disease and asthma | 18 months |