Chronic Obstructive Pulmonary DiseaseNCT01145300
Biomarkers in Chronic Obstructive Pulmonary Disease (COPD)
An observational study of Chronic Obstructive Pulmonary Disease, run by Leiden University Medical Center at 1 site in Netherlands.
Trial summary
Chronic obstructive pulmonary disease (COPD) is one of the leading causes of morbidity and mortality worldwide and is characterized by fixed airflow obstruction. The cornerstone of the disease is chronic inflammation leading to narrowing of the small airways and thus impairment of lung function. Read more about this study
- Who is it for?
- Ages 40 to 80 years
- Conditions the study is for
- Chronic Obstructive Pulmonary Disease
- How many people
- 32 participants
- Where
- 1 siteNetherlands
- Study dates
- Jun 2010to May 2011
- 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 40 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with and without COPD scheduled for lung resection for lung cancer.
Who may be able to join
- Male or female subject, age > 40 years, current or ex-smokers.
- Planned lung resection for primary lung cancer of any size.
- Patients with COPD: irreversible airflow limitation (postbronchodilator FEV1/FVC < 70% according to GOLD guidelines). Patients already receiving inhalative therapy can continue their medication. Patients showing a partial reversibility after bronchodilation (postbronchodilator FEV1 increase > 150 ml but < 200ml) and complaining respiratory symptoms (e.g. dyspnea at exertion) will be treated preoperatively with a short-acting beta-agonist to achieve optimal perioperative conditions.
- Patients without COPD: postbronchodilator FEV1/FVC > 70%.
- Patients have to be in clinical stable condition (no symptoms of respiratory tract infection for at least 2 weeks prior to the study).
- Written informed consent.
Who cannot join
- Patients with a history of asthma or other active lung disease.
- Lung resection for other reasons than lung cancer (e.g. infective diseases like bronchiectasis).
Trial locations and contacts
1 site in 1 country.
Netherlands1 site
Department of Pulmonology, Leiden University Medical Center
Leiden, 2333 ZA
About this study
Official title: Relationship Between Exhaled Markers and Airway Pathology in Smokers With and Without Airflow Obstruction
Chronic obstructive pulmonary disease (COPD) is one of the leading causes of morbidity and mortality worldwide and is characterized by fixed airflow obstruction. The cornerstone of the disease is chronic inflammation leading to narrowing of the small airways and thus impairment of lung function. Compared to spirometry, the single breath N2-washout-test is more sensitive to identify the regional heterogeneity of bronchial airflow obstruction in the small airways.
The aim of this study is to evaluate whether there is a correlation between the sbN2-test, markers in exhaled air and the inflammatory cells in the small airways.
Read the detailed description
The cornerstone of COPD is a chronic inflammation leading to narrowing of the small airways and thus impairment of lung function. Spirometry, the most frequently used pulmonary function test for diagnosing and monitoring disease, mostly reflects obstruction of the larger airways. The single breath N2-test, however, is more sensitive to identify the regional heterogeneity of bronchial airflow obstruction in the small airways, a main site of injury in COPD.
The aim of this study is to evaluate whether there is a correlation between the sbN2-test, markers in exhaled air and the inflammatory cells in the small airways.
This protocol describes a cross-sectional, explorative trial in at least 16 patients with COPD (up to GOLD III) and 8 patients without COPD who are scheduled for surgical resection for primary lung cancer. Immunohistological methods will be used to characterize the airways (large and small) inflammation pattern in macroscopically normal tissue containing small and large airways collected from sites distant from the tumor. Inflammatory markers will be measured in exhaled breath (exhaled breath condensate, exhaled NO) and be correlated to the sbN2 test. Breath patterns before and after lung cancer surgery will be assessed by the electronic nose and differential mobility spectrometry.
We hypothesize that the sbN2-test and inflammatory markers in exhaled breath reflect changes at peripheral tissue level. Therefore the results of the present study would lead to validation of these non-invasive tools for studies into the pathogenesis of obstructive lung disease, to increased knowledge about the relationship between airway inflammation and small airways obstruction, and may provide further support for the small airways as a specific target for inhaled drug delivery.
- Conditions
- Chronic Obstructive Pulmonary Disease
- Keywords
- COPD, Inflammation, Small airways
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive, Inflammation
What is being measured
The primary outcome is the main question the study is designed to answer.
1. Slope of the sbN2-test (phase III/IV) 2. Inflammatory markers in exhaled breath (NO, EBC, eNose, DMS) 3. Inflammation: localisation, numbers and profile of inflammatory cells in the large/small airways (neutrophils, macrophages, mastcells)
To demonstrate that the change in slope of the sbN2-test (phase III/IV) is correlated to an influx of inflammatory cells in the small airways (histology, morphology, immunopathology) and to inflammatory markers in exhaled breath in patients with normal and abnormal small airways function.
Measured: 1 week before surgery
Secondary outcomes (3)
Expression of the 1,25(OH)2D3 degrading enzyme CYP24A1 and antimicrobial peptides in small and large airways
To assess whether there is a relationship between the expression of the 1,25(OH)2D3 degrading enzyme CYP24A1 and antimicrobial peptides in small and large airways in COPD patients and whether there is a correlation with local inflammation and lung function.
Measured: within 1 week after surgery
Markers in exhaled breath
To demonstrate that the presence of lung cancer per se is a condition leading to a change in the breath pattern. Exhaled breath patterns will be assessed by the eNose and the differential mobility spectrometry before and after lung cancer surgery.
Measured: 1 week before and 3 months after surgery
Expression of macrophage markers (Mf1 and Mf2) and chymase/tryptase in mast cell subsets
To assess whether there is a difference in expression of macrophage Mf1 and Mf2 markers, and in mast cell subsets (chymase/tryptase positive vs. tryptase positive) in small and large airways from patients with COPD at lung tissue level.
Measured: within 1 week after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jun 2010 (estimated)
- Study startJun 2010
- Primary completionMay 2011
- Study completionMay 2011
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.
- More trials run by Leiden University Medical CenterThe sponsor's other registered studies.
- 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
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- Leiden University Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yvonne Nussbaumer-Ochsner, Leiden University Medical Center
- Investigators
- Klaus F. Rabe, MD, PhD, Principal investigator, Leiden University Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01145300
- Sponsor's protocol ID
- P10.045
- Status last verified
- Jan 2012
- First submitted
- 14 Jun 2010
- Last updated
- 26 Jan 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Jan 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Relationship Between Exhaled Markers and Airway Pathology in Smokers With and Without Airflow Obstruction
- ClinicalTrials.gov ID
- NCT01145300
- Acronym / sponsor ID
- P10.045
- Conditions
- Chronic Obstructive Pulmonary Disease
- Keywords
- COPD, Inflammation, Small airways
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- Leiden University Medical CenterUniversity, hospital or other
- Study start
- Jun 2010
- Primary completion
- May 2011 (actual)
- Study completion
- May 2011 (actual)
- First posted
- 16 Jun 2010 (estimated)
- 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.
Chronic obstructive pulmonary disease (COPD) is one of the leading causes of morbidity and mortality worldwide and is characterized by fixed airflow obstruction. The cornerstone of the disease is chronic inflammation leading to narrowing of the small airways and thus impairment of lung function. Compared to spirometry, the single breath N2-washout-test is more sensitive to identify the regional heterogeneity of bronchial airflow obstruction in the small airways.
The aim of this study is to evaluate whether there is a correlation between the sbN2-test, markers in exhaled air and the inflammatory cells in the small airways.
Detailed description
The cornerstone of COPD is a chronic inflammation leading to narrowing of the small airways and thus impairment of lung function. Spirometry, the most frequently used pulmonary function test for diagnosing and monitoring disease, mostly reflects obstruction of the larger airways. The single breath N2-test, however, is more sensitive to identify the regional heterogeneity of bronchial airflow obstruction in the small airways, a main site of injury in COPD.
The aim of this study is to evaluate whether there is a correlation between the sbN2-test, markers in exhaled air and the inflammatory cells in the small airways.
This protocol describes a cross-sectional, explorative trial in at least 16 patients with COPD (up to GOLD III) and 8 patients without COPD who are scheduled for surgical resection for primary lung cancer. Immunohistological methods will be used to characterize the airways (large and small) inflammation pattern in macroscopically normal tissue containing small and large airways collected from sites distant from the tumor. Inflammatory markers will be measured in exhaled breath (exhaled breath condensate, exhaled NO) and be correlated to the sbN2 test. Breath patterns before and after lung cancer surgery will be assessed by the electronic nose and differential mobility spectrometry.
We hypothesize that the sbN2-test and inflammatory markers in exhaled breath reflect changes at peripheral tissue level. Therefore the results of the present study would lead to validation of these non-invasive tools for studies into the pathogenesis of obstructive lung disease, to increased knowledge about the relationship between airway inflammation and small airways obstruction, and may provide further support for the small airways as a specific target for inhaled drug delivery.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 40 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with and without COPD scheduled for lung resection for lung cancer.
Key inclusion criteria (6 listed)
- Male or female subject, age > 40 years, current or ex-smokers.
- Planned lung resection for primary lung cancer of any size.
- Patients with COPD: irreversible airflow limitation (postbronchodilator FEV1/FVC < 70% according to GOLD guidelines). Patients already receiving inhalative therapy can continue their medication. Patients showing a partial reversibility after bronchodilation (postbronchodilator FEV1 increase > 150 ml but < 200ml) and complaining respiratory symptoms (e.g. dyspnea at exertion) will be treated preoperatively with a short-acting beta-agonist to achieve optimal perioperative conditions.
- Patients without COPD: postbronchodilator FEV1/FVC > 70%.
- Patients have to be in clinical stable condition (no symptoms of respiratory tract infection for at least 2 weeks prior to the study).
Key exclusion criteria (2 listed)
- Patients with a history of asthma or other active lung disease.
- Lung resection for other reasons than lung cancer (e.g. infective diseases like bronchiectasis).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
1. Slope of the sbN2-test (phase III/IV) 2. Inflammatory markers in exhaled breath (NO, EBC, eNose, DMS) 3. Inflammation: localisation, numbers and profile of inflammatory cells in the large/small airways (neutrophils, macrophages, mastcells)
Time frame: 1 week before surgery
To demonstrate that the change in slope of the sbN2-test (phase III/IV) is correlated to an influx of inflammatory cells in the small airways (histology, morphology, immunopathology) and to inflammatory markers in exhaled breath in patients with normal and abnormal small airways function.
3 secondary outcomes
Expression of the 1,25(OH)2D3 degrading enzyme CYP24A1 and antimicrobial peptides in small and large airways
Time frame: within 1 week after surgery
Markers in exhaled breath
Time frame: 1 week before and 3 months after surgery
Expression of macrophage markers (Mf1 and Mf2) and chymase/tryptase in mast cell subsets
Time frame: within 1 week after surgery
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 26 Jan 2012.
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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.
Klaus F. Rabe, MD, PhD principal investigator
Leiden University Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Chronic Obstructive Pulmonary Disease, run by Leiden University Medical Center at 1 site in Netherlands.
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 6 inclusion and 2 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 26 Jan 2012. 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 Netherlands. 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?
1. Slope of the sbN2-test (phase III/IV) 2. Inflammatory markers in exhaled breath (NO, EBC, eNose, DMS) 3. Inflammation: localisation, numbers and profile of inflammatory cells in the large/small airways (neutrophils, macrophages, mastcells) (time frame: 1 week before surgery). 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 26 Jan 2012.