Obstructive Lung Diseases
Conditions
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)
Interventions
DIAGNOSTIC_TESTBlood 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.
Sponsors
Heidelberg University
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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 \[right heart catheter\])
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 |
Countries
Australia, Germany
Outcome results
None listed