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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Total Enrollment

14 participants

Study Classification

OBSERVATIONAL

Study Start Date

2019-02-14

Study Completion Date

2020-01-08

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.

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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)

Conditions

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Obstructive Lung Diseases

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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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)

Blood sampling, FeNO, bronchoalveolar lavage, bronchoscopic tissue sampling

Intervention Type DIAGNOSTIC_TEST

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)

Blood sampling, FeNO, bronchoalveolar lavage, bronchoscopic tissue sampling

Intervention Type DIAGNOSTIC_TEST

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.

Interventions

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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.

Intervention Type DIAGNOSTIC_TEST

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 \[right heart catheter\])

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No