Trials / Terminated
TerminatedNCT03845257
Correlation of FeNO, Blood Eosinophils, Bronchoalveolar Lavage Findings and Bronchial Epithelium Histopathology in Patients With Chronic Obstructive Pulmonary Disease and Asthma
- Status
- Terminated
- Phase
- —
- Study type
- Observational
- Enrollment
- 14 (actual)
- Sponsor
- Heidelberg University · Academic / Other
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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)
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DIAGNOSTIC_TEST | 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. |
Timeline
- Start date
- 2019-02-14
- Primary completion
- 2020-01-08
- Completion
- 2020-01-08
- First posted
- 2019-02-19
- Last updated
- 2022-07-07
Locations
3 sites across 2 countries: Australia, Germany
Source: ClinicalTrials.gov record NCT03845257. Inclusion in this directory is not an endorsement.