Clinical trial NCT03845257: Correlation of FeNO, Blood Eosinophils, Bronchoalveolar Lavage Findings and Bronchial Epithelium Histopathology in Patients With Chronic Obstructive Pulmonary Disease and Asthma
Official title: Correlation of FeNO, Blood Eosinophils, Bronchoalveolar Lavage Findings and Bronchial Epithelium Histopathology in Patients With Chronic Obstructive Pulmonary Disease and Asthma
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Obstructive Lung Diseases
Lead sponsor: Heidelberg University
Sponsor class: OTHER
First posted: 2019-02-19
Enrollment: 14
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with diagnosis of COPD or asthma (according to the guidelines)

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)

Eligibility criteria: 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 \[right heart catheter\])

Primary outcomes:
measure: Assessment of eosinophilic inflammation by correlating tissue eosinophilia with eosinophil count in blood/BAL and FeNO measurement.
timeFrame: 18 months
Secondary outcomes:
Other outcomes:
Locations:
city: Sydney
country: Australia
facility: Macquarie University Sydney
state: New South Wales
city: Borstel
country: Germany
facility: Division of Clinical Infectious Diseases/Research Center Borstel
city: Heidelberg
country: Germany
facility: Thoraxklinik University Heidelberg
Study officials:
affiliation: Thoraxklinik University Heidelberg
name: Daniela Gompelmann
role: PRINCIPAL_INVESTIGATOR
References: