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.
ID
Source
Brief title
Condition
- Bronchial disorders (excl neoplasms)
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
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.
Secondary outcome
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.
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.
Furthermore we are interested 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.
Background summary
Chronic obstructive pulmonary disease (COPD) is one of the leading causes of
morbidity and mortality worldwide and is characterized by a fixed airflow
obstruction. The cornerstone of the disease is a chronic inflammation leading
to a narrowing of the small airways and thus impairing lung function.
Spirometry, the most frequently used pulmonary function test for diagnosing and
monitoring disease, mostly reflects obstruction in the larger airways. The
single breath N2-test (sbN2-test) however is more sensitive to localize the
regional heterogeneity of bronchial airflow obstruction in the small airways,
the main site of injury in COPD.
Study objective
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.
Study design
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.
Study burden and risks
The collection of exhaled air is of no burden and risk for the participation in
this study. Pulmonary function tests are performed by all patients who are
scheduled for lung cancer surgery and therefore this is information available
from clinical practice. There is no direct benefit for the patient to
participate in this study.
Albinusdreef 2
2333 ZA
NL
Albinusdreef 2
2333 ZA
NL
Listed location countries
Age
Inclusion criteria
- Male or female subject, age > 40 years, current or ex-smokers
- Plannend lung resection for primary lung cancer of any size.
- COPD: irreversible airflow limitation (postbronchodilator FEV1/FVC < 70% according to GOLD guidelines).
- non-COPD: FEV1/FVC >70%
-Written informed consent.
Exclusion criteria
-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).
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL31666.058.10 |