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difficult patient recruitment
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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.
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:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Patients with COPD | The following parameters are to be evaluated:
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| Patients with asthma | The following parameters are to be evaluated:
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Blood sampling, FeNO, bronchoalveolar lavage, bronchoscopic tissue sampling | 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. |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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Patients with diagnosis of COPD or asthma (according to the guidelines)
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| Name | Affiliation | Role |
|---|---|---|
| Daniela Gompelmann | Thoraxklinik University Heidelberg | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Macquarie University Sydney | Sydney | New South Wales | Australia | |||
| Division of Clinical Infectious Diseases/Research Center Borstel |
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| Borstel |
| Germany |
| Thoraxklinik University Heidelberg | Heidelberg | 69126 | Germany |
| ID | Term |
|---|---|
| D008173 | Lung Diseases, Obstructive |
| ID | Term |
|---|---|
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
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| ID | Term |
|---|---|
| D001800 | Blood Specimen Collection |
| D000089142 | Fractional Exhaled Nitric Oxide Testing |
| ID | Term |
|---|---|
| D013048 | Specimen Handling |
| D019411 | Clinical Laboratory Techniques |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
| D011677 | Punctures |
| D013514 | Surgical Procedures, Operative |
| D008919 | Investigative Techniques |
| D001944 | Breath Tests |
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