Chronic Obstructive Pulmonary DiseaseNCT04775394
Activation of Apoptosis-related Receptors on Alveolar Macrophages
A study testing Bronchoscopy in people with Chronic Obstructive Pulmonary Disease, run by Prof. Dr. Jens Hohlfeld at 1 site in Germany.
Trial summary
The aim is to understand whether activation of receptors involved in clearance of apoptotic cells will improve efferocytosis in COPD patients in vitro and whether generation of pro-inflammatory cytokines can be decreased in COPD patients. Read more about this study
- Who is it for?
- Ages 40 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Chronic Obstructive Pulmonary Disease
- What is being tested?
- Bronchoscopy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 28 participants
- Where
- 1 siteGermany
- Study dates
- 1 Jan 2021to 21 Jul 2023
- Phase
- Interventional
- 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 40 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Healthy volunteers
- Able and willing to give written informed consent.
- Healthy male and female subjects, aged 18-80 years for the initial part and 40-80 years for the main part, inclusive. Women will be considered for inclusion if they are: Not pregnant, as confirmed by pregnancy test (see flow chart), and not nursing. Of non-child bearing potential (i.e. physiologically incapable of becoming pregnant, including any female who is pre-menarchial or post-menopausal, with documented proof of hysterectomy or tubal ligation, or meets clinical criteria for menopause and has been amenorrhoeic for more than 1 year prior to the screening visit). Of childbearing potential and using a highly effective method of contraception during the entire study (vasectomised partner, sexual abstinence - the lifestyle of the female should be such that there is complete abstinence from intercourse from two weeks prior to the first dose of study medication until at least 72 hours after treatment -, implants, injectables, combined oral contraceptives, hormonal intrauterine devices (IUDs) or double-barrier methods, i.e. any double combination of IUD, condom with spermicidal gel, diaphragm, sponge, and cervical cap).
- Normal lung function with Forced Expiratory Volume in 1 second (FEV1) predicted ≥ 80% and FEV1/Forced Vital Capacity (FVC) > 70%.
- Body mass index between 18 and 32 kg/m2
- Ex-smokers since at least 12 months with a smoking history of at least 10 pack years.
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- Able and willing to give written informed consent
- COPD subjects
- Male and female subjects, aged 40-80 years, inclusive. Women will be considered for inclusion if they are: Not pregnant, as confirmed by pregnancy test (see flow chart), and not nursing. Of non-child bearing potential (i.e. physiologically incapable of becoming pregnant, including any female who is pre-menarchial or post-menopausal, with documented proof of hysterectomy or tubal ligation, or meets clinical criteria for menopause and has been amenorrhoeic for more than 1 year prior to the screening visit). Of childbearing potential and using a highly effective method of contraception during the entire study (vasectomised partner, sexual abstinence - the lifestyle of the female should be such that there is complete abstinence from intercourse from two weeks prior to the first dose of study medication until at least 72 hours after treatment -, implants, injectables, combined oral contraceptives, hormonal IUDs or double-barrier methods, i.e. any double combination of IUD, condom with spermicidal gel, diaphragm, sponge, and cervical cap).
- Clinical diagnosis of COPD stage II and III
- History of chronic cough and sputum production
- FEV1/FVC <70% post-bronchodilator at visit 1
- FEV1 30-80% of the predicted normal value post-bronchodilator at visit 1
- FEV1 >1.5 L
- Absence of lung emphysema assessed by pulmonary function measurement at visit 1: Total Lung Capacity (TLC) <120% of predicted normal, Residual Volume (RV) <120% of predicted normal, Diffusing Capacity for Carbon Monoxide (DLCO) >80%
- Ex-smokers since at least 12 months with a smoking history of at least 10 pack years.
- Body mass index between 18 and 32 kg/m2.
- Able and willing to give written informed consent.
Who cannot join
- Healthy volunteers
- Past or present disease, which as judged by the investigator, may affect the outcome of the study or put the subject at risk because of participation in the study. These diseases include, but are not limited to, cardiovascular disease, malignancy, hepatic disease, renal disease, haematological disease, neurological disease, psychiatric disease, endocrine disease, infectious disease, inflammatory disease or pulmonary disease (including but not confined to asthma, tuberculosis, bronchiectasis or cystic fibrosis)
- Regular intake of any prescribed or over the counter medication. Exceptions include paracetamol for pain relief, oral contraceptive medication, hormonal replacement therapy, dietary and vitamin supplements
- Clinically relevant history of allergy as judged by the investigator
- Intolerance against standard medication used during bronchoscopy, e.g. lidocaine, midazolam.
- Infections of the lower respiratory tract within 6 weeks prior to screening
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- Infections of the upper respiratory tract within 2 weeks prior to screening
- Any clinically relevant abnormal findings in physical examination, clinical chemistry, haematology, urinalysis, vital signs, lung function, or ECG at Visit 1, which, in the opinion of the investigator, may either put the subject at risk because of participation in the study, or may influence the results of the study.
- HIV (Type I + Type II), hepatitis B or C, tuberculosis, or Sars-CoV-2 positive or not performed at visit 1
- Positive drug screen for methadone, cannabis, opiates, cocaine metabolites, amphetamines, barbiturates and benzodiazepines at visit 1
- History of drug or alcohol abuse
- Risk of non-compliance with study procedures
- Suspected inability to understand the protocol requirements, instructions and study-related restrictions, the nature, scope, and possible consequences of the study
- COPD subjects
- Past or present disease other than COPD, which as judged by the investigator, may affect the outcome of the study or put the subject at risk because of participation in the study. These diseases include, but are not limited to, cardiovascular disease, malignancy, hepatic disease, renal disease, haematological disease, neurological disease, psychiatric disease, endocrine disease, infectious disease, inflammatory disease or pulmonary disease (including but not confined to asthma, tuberculosis, bronchiectasis or cystic fibrosis).
- Regular intake of any prescribed or over the counter medication, which as judged by the investigator, may affect the outcome of the study or put the subject at risk because of participation in the study. Explicitly allowed is treatment with short-acting beta-2-agonists (SABA)/long-acting beta-2-agonists (LABA)/long-acting muscarinic-antagonists (LAMA), paracetamol for pain relief, oral contraceptive medication, hormonal replacement therapy, dietary and vitamin supplements. Not allowed are inhaled corticosteroids.
- Clinically relevant history of allergy as judged by the investigator.
- Intolerance against standard medication used during bronchoscopy, e.g. lidocaine, midazolam.
- Infections of the lower respiratory tract within 6 weeks prior to screening.
- Infections of the upper respiratory tract within 2 weeks prior to screening
- Exacerbation of COPD (treatment with oral or parenteral antibiotics and/or oral or parenteral glucocoterticosteroids (GCS) and/or hospitalization related to COPD) within 60 days of visit 1.
- Any clinically relevant abnormal findings in physical examination, clinical chemistry, hematology, urinalysis, vital signs, lung function, or ECG at Visit 1, which, in the opinion of the investigator, may either put the subject at risk because of participation in the study, or may influence the results of the study.
- HIV (Type I + Type II), hepatitis B or C, tuberculosis, or Sars-CoV2 positive or not performed at visit 1.
- Positive drug screen for methadone, cannabis, opiates, cocaine metabolites, amphetamines, barbiturates and benzodiazepines at visit 1.
- History of drug or alcohol abuse.
- Risk of non-compliance with study procedures.
- Suspected inability to understand the protocol requirements, instructions and study-related restrictions, the nature, scope, and possible consequences of the study.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Activation of Apoptosis-related Receptors on Alveolar Macrophages From COPD Patients and Healthy Controls
The aim is to understand whether activation of receptors involved in clearance of apoptotic cells will improve efferocytosis in COPD patients in vitro and whether generation of pro-inflammatory cytokines can be decreased in COPD patients.
Read the detailed description
In order to assess pathway activation in COPD macrophages, alveolar macrophages will be isolated from BAL of COPD patients and healthy controls. Alveolar macrophages will be co-cultured in vitro with apoptotic cells and treated with compounds. In addition, BAL fluid will be frozen for later testing of soluble mediators.
- Conditions
- Chronic Obstructive Pulmonary Disease
- Being tested
- Bronchoscopy
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BronchoscopyOther
Bronchoalveolar lavage, mucosal biopsy and bronchial brushes during bronchoscopy
| Study group | Role | What they receive |
|---|---|---|
| Pilot Part: Healthy subjects | Experimental | 3-5 healthy ex-smokers with normal lung function to establish methods Receives: Other: Bronchoscopy |
| Main Part: COPD patients and Healthy Controls | Experimental | 8 subjects with COPD stage II and III who are ex-smokers and have a history of chronic cough and sputum production and 5-8 healthy, age-matched controls Receives: Other: Bronchoscopy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of pH-Rhodo-positive alveolar macrophages
Research compounds will be tested for the ability to influence the amount of efferocytosis against apoptotic cells, measuring the relative numbers of isolated alveolar macrophages that performed efferocytosis using flow cytometry.
Measured: Ex-vivo, after collection of bronchoalveolar lavage (BAL) on Day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Mar 2021
- Study start1 Jan 2021
- Primary completion21 Jul 2023
- Study completion21 Jul 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Obstructive Pulmonary DiseaseStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Model description
- Enrolment will healthy subjects first, followed by subjects with COPD
- Masking
- None (open label)
- Enrolment
- 28 participants (actual)
Sponsor and investigators
- Lead sponsor
- Prof. Dr. Jens Hohlfeld
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Prof. Dr. Jens Hohlfeld, Fraunhofer-Institute of Toxicology and Experimental Medicine
- Investigators
- Jens M Hohlfeld, Prof. Dr., Principal investigator, Fraunhofer ITEM Hannover, Germany
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04775394
- Sponsor's protocol ID
- 20-04 ROBAL
- Status last verified
- Jul 2023
- First submitted
- 15 Feb 2021
- Last updated
- 1 Aug 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Activation of Apoptosis-related Receptors on Alveolar Macrophages From COPD Patients and Healthy Controls
- ClinicalTrials.gov ID
- NCT04775394
- Acronym / sponsor ID
- 20-04 ROBAL
- Conditions
- Chronic Obstructive Pulmonary Disease
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 28 participants (actual)
- Lead sponsor
- Prof. Dr. Jens HohlfeldUniversity, hospital or other
- Study start
- 1 Jan 2021 (actual)
- Primary completion
- 21 Jul 2023 (actual)
- Study completion
- 21 Jul 2023 (actual)
- First posted
- 1 Mar 2021 (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.
The aim is to understand whether activation of receptors involved in clearance of apoptotic cells will improve efferocytosis in COPD patients in vitro and whether generation of pro-inflammatory cytokines can be decreased in COPD patients.
Detailed description
In order to assess pathway activation in COPD macrophages, alveolar macrophages will be isolated from BAL of COPD patients and healthy controls. Alveolar macrophages will be co-cultured in vitro with apoptotic cells and treated with compounds. In addition, BAL fluid will be frozen for later testing of soluble mediators.
Study design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Enrolment will healthy subjects first, followed by subjects with COPD
| Arm | Type | Receives |
|---|---|---|
| Pilot Part: Healthy subjects | Experimental | Other: Bronchoscopy3-5 healthy ex-smokers with normal lung function to establish methods |
| Main Part: COPD patients and Healthy Controls | Experimental | Other: Bronchoscopy8 subjects with COPD stage II and III who are ex-smokers and have a history of chronic cough and sputum production and 5-8 healthy, age-matched controls |
Who may qualify
- Ages
- 40 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (18 listed)
- Healthy volunteers
- Able and willing to give written informed consent.
- Healthy male and female subjects, aged 18-80 years for the initial part and 40-80 years for the main part, inclusive. Women will be considered for inclusion if they are: Not pregnant, as confirmed by pregnancy test (see flow chart), and not nursing. Of non-child bearing potential (i.e. physiologically incapable of becoming pregnant, including any female who is pre-menarchial or post-menopausal, with documented proof of hysterectomy or tubal ligation, or meets clinical criteria for menopause and has been amenorrhoeic for more than 1 year prior to the screening visit). Of childbearing potential and using a highly effective method of contraception during the entire study (vasectomised partner, sexual abstinence - the lifestyle of the female should be such that there is complete abstinence from intercourse from two weeks prior to the first dose of study medication until at least 72 hours after treatment -, implants, injectables, combined oral contraceptives, hormonal intrauterine devices (IUDs) or double-barrier methods, i.e. any double combination of IUD, condom with spermicidal gel, diaphragm, sponge, and cervical cap).
- Normal lung function with Forced Expiratory Volume in 1 second (FEV1) predicted ≥ 80% and FEV1/Forced Vital Capacity (FVC) > 70%.
- Body mass index between 18 and 32 kg/m2
Key exclusion criteria (27 listed)
- Healthy volunteers
- Past or present disease, which as judged by the investigator, may affect the outcome of the study or put the subject at risk because of participation in the study. These diseases include, but are not limited to, cardiovascular disease, malignancy, hepatic disease, renal disease, haematological disease, neurological disease, psychiatric disease, endocrine disease, infectious disease, inflammatory disease or pulmonary disease (including but not confined to asthma, tuberculosis, bronchiectasis or cystic fibrosis)
- Regular intake of any prescribed or over the counter medication. Exceptions include paracetamol for pain relief, oral contraceptive medication, hormonal replacement therapy, dietary and vitamin supplements
- Clinically relevant history of allergy as judged by the investigator
- Intolerance against standard medication used during bronchoscopy, e.g. lidocaine, midazolam.
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 |
|---|---|---|
| BronchoscopyBronchoalveolar lavage, mucosal biopsy and bronchial brushes during bronchoscopy | Other | Main Part: COPD patients and Healthy Controls, Pilot Part: Healthy subjects |
Primary outcome
Percentage of pH-Rhodo-positive alveolar macrophages
Time frame: Ex-vivo, after collection of bronchoalveolar lavage (BAL) on Day 1
Research compounds will be tested for the ability to influence the amount of efferocytosis against apoptotic cells, measuring the relative numbers of isolated alveolar macrophages that performed efferocytosis using flow cytometry.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Aug 2023.
- Individual participant dataSharing planned: No
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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.
Jens M Hohlfeld, Prof. Dr. principal investigator
Fraunhofer ITEM Hannover, Germany
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Bronchoscopy in people with Chronic Obstructive Pulmonary Disease, run by Prof. Dr. Jens Hohlfeld at 1 site in Germany.
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 18 inclusion and 27 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: finished, as of the sponsor's last update on 1 Aug 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Percentage of pH-Rhodo-positive alveolar macrophages (time frame: Ex-vivo, after collection of bronchoalveolar lavage (BAL) on Day 1). 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 1 Aug 2023.