Obstructive Lung DiseasesNCT03845257
Correlation of FeNO, Blood Eosinophils, Bronchoalveolar Lavage Findings and Bronchial Epithelium Histopathology in Patients With Chronic Obstructive Pulmonary Disease and Asthma
An observational study of Obstructive Lung Diseases, run by Heidelberg University at 3 sites in 2 countries.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Obstructive Lung Diseases
- What is being tested?
- Blood sampling, FeNO, bronchoalveolar lavage, bronchoscopic tissue sampling
- Type of treatment
- Pill or oral medicine
- How many people
- 14 participants
- Where
- 3 sitesin 2 countries
- Study dates
- 14 Feb 2019to 8 Jan 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with diagnosis of COPD or asthma (according to the guidelines)
Who may be able to join
- 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
Who cannot join
- 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
Show all 9Show fewer
- 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])
Trial locations and contacts
3 sites in 2 countries.
3 sites in 2 countries
Germany2 sites
Division of Clinical Infectious Diseases/Research Center Borstel
Borstel
Thoraxklinik University Heidelberg
Heidelberg, 69126
About this study
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.
Read the 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
- Obstructive Lung Diseases
- Being tested
- Blood sampling, FeNO, bronchoalveolar lavage, bronchoscopic tissue sampling
- Medical subject headings
- Lung Diseases, Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Blood sampling, FeNO, bronchoalveolar lavage, bronchoscopic tissue samplingDiagnostic 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.
| Study group | Role | What they receive |
|---|---|---|
| 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) Receives: Diagnostic Test: Blood sampling, FeNO, bronchoalveolar lavage, bronchoscopic tissue sampling | |
| 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) Receives: Diagnostic Test: Blood sampling, FeNO, bronchoalveolar lavage, bronchoscopic tissue sampling |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Feb 2019
- Study start14 Feb 2019
- Primary completion8 Jan 2020
- Study completion8 Jan 2020
Why it stopped: difficult patient recruitment
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Obstructive Lung DiseasesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 14 participants (actual)
Sponsor and investigators
- Lead sponsor
- Heidelberg University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Daniela Gompelmann, Heidelberg University
- Investigators
- Daniela Gompelmann, Principal investigator, Thoraxklinik University Heidelberg
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03845257
- Sponsor's protocol ID
- Protocol DG3.0 - 25.06.2018
- Status last verified
- Jul 2022
- First submitted
- 14 Feb 2019
- Last updated
- 7 Jul 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 7 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Correlation of FeNO, Blood Eosinophils, Bronchoalveolar Lavage Findings and Bronchial Epithelium Histopathology in Patients With Chronic Obstructive Pulmonary Disease and Asthma
- ClinicalTrials.gov ID
- NCT03845257
- Acronym / sponsor ID
- Protocol DG3.0 - 25.06.2018
- Conditions
- Obstructive Lung Diseases
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: difficult patient recruitment
- Enrolment
- 14 participants (actual)
- Lead sponsor
- Heidelberg UniversityUniversity, hospital or other
- Study start
- 14 Feb 2019 (actual)
- Primary completion
- 8 Jan 2020 (actual)
- Study completion
- 8 Jan 2020 (actual)
- First posted
- 19 Feb 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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)
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Patients with COPD | – | Diagnostic Test: Blood sampling, FeNO, bronchoalveolar lavage, bronchoscopic tissue samplingThe following parameters are to be evaluated: * Blood eosinophils * FeNO * Eosinophils in bronchoalveolar lavage * Tissue eosinophilia (protected specimen brush sampling, endobronchial biopsy) |
| Patients with asthma | – | Diagnostic Test: Blood sampling, FeNO, bronchoalveolar lavage, bronchoscopic tissue samplingThe following parameters are to be evaluated: * Blood eosinophils * FeNO * Eosinophils in bronchoalveolar lavage * Tissue eosinophilia (protected specimen brush sampling, endobronchial biopsy) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with diagnosis of COPD or asthma (according to the guidelines)
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Blood sampling, FeNO, bronchoalveolar lavage, bronchoscopic tissue samplingBlood 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. | Diagnostic test | Patients with COPD, Patients with asthma |
Primary outcome
Assessment of eosinophilic inflammation by correlating tissue eosinophilia with eosinophil count in blood/BAL and FeNO measurement.
Time frame: 18 months
Correlation of FeNO, blood eosinophils, bronchoalveolar lavage findings and bronchial epithelium histopathology in patients with chronic obstructive pulmonary disease and asthma
Results and safety
The study was stopped early (reason given: difficult patient recruitment). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Jul 2022.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Daniela Gompelmann principal investigator
Thoraxklinik University Heidelberg
3 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Obstructive Lung Diseases, run by Heidelberg University at 3 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 7 Jul 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Germany, Australia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: difficult patient recruitment). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Assessment of eosinophilic inflammation by correlating tissue eosinophilia with eosinophil count in blood/BAL and FeNO measurement. (time frame: 18 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Jul 2022.