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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT03845257




Registration number
NCT03845257
Ethics application status
Date submitted
14/02/2019
Date registered
19/02/2019
Date last updated
7/07/2022

Titles & IDs
Public title
Correlation of FeNO, Blood Eosinophils, Bronchoalveolar Lavage Findings and Bronchial Epithelium Histopathology in Patients With Chronic Obstructive Pulmonary Disease and Asthma
Scientific title
Correlation of FeNO, Blood Eosinophils, Bronchoalveolar Lavage Findings and Bronchial Epithelium Histopathology in Patients With Chronic Obstructive Pulmonary Disease and Asthma
Secondary ID [1] 0 0
Protocol DG3.0 - 25.06.2018
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Obstructive Lung Diseases 0 0
Condition category
Condition code
Respiratory 0 0 0 0
Chronic obstructive pulmonary disease

Intervention/exposure
Study type
Observational
Patient registry
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Diagnosis / Prognosis - Blood sampling, FeNO, bronchoalveolar lavage, bronchoscopic tissue sampling

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)

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)


Diagnosis / Prognosis: 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 code [1] 0 0
Diagnosis / Prognosis
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Assessment of eosinophilic inflammation by correlating tissue eosinophilia with eosinophil count in blood/BAL and FeNO measurement.
Timepoint [1] 0 0
18 months

Eligibility
Key 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
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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])

Study design
Purpose
Duration
Selection
Timing
Prospective
Statistical methods / analysis

Recruitment
Recruitment status
Terminated
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
14/02/2019
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
8/01/2020
Sample size
Target
Accrual to date
Final
14
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 0 0
Macquarie University Sydney - Sydney
Recruitment postcode(s) [1] 0 0
- Sydney
Recruitment outside Australia
Country [1] 0 0
Germany
State/province [1] 0 0
Borstel
Country [2] 0 0
Germany
State/province [2] 0 0
Heidelberg

Funding & Sponsors
Primary sponsor type
Other
Name
Heidelberg University
Address
Country

Ethics approval
Ethics application status

Summary
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.
Trial website
https://clinicaltrials.gov/ct2/show/NCT03845257
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Daniela Gompelmann
Address 0 0
Thoraxklinik University Heidelberg
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT03845257