Chronic Obstructive Pulmonary Disease Clinical Trial
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.
Status | Completed |
Enrollment | 32 |
Est. completion date | May 2011 |
Est. primary completion date | May 2011 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 40 Years to 80 Years |
Eligibility |
Inclusion Criteria: - 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. 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). |
Observational Model: Cohort, Time Perspective: Prospective
Country | Name | City | State |
---|---|---|---|
Netherlands | Department of Pulmonology, Leiden University Medical Center | Leiden |
Lead Sponsor | Collaborator |
---|---|
Leiden University Medical Center |
Netherlands,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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. | 1 week before surgery | No |
Secondary | 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. | within 1 week after surgery | No |
Secondary | 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. | 1 week before and 3 months after surgery | No |
Secondary | 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. | within 1 week after surgery | No |
Status | Clinical Trial | Phase | |
---|---|---|---|
Completed |
NCT05102305 -
A Multi-center,Prospective, OS to Evaluate the Effectiveness of 'NAC' Nebulizer Therapy in COPD (NEWEST)
|
||
Completed |
NCT01867762 -
An Effectiveness and Safety Study of Inhaled JNJ 49095397 (RV568) in Patients With Moderate to Severe Chronic Obstructive Pulmonary Disease
|
Phase 2 | |
Recruiting |
NCT05562037 -
Stepped Care vs Center-based Cardiopulmonary Rehabilitation for Older Frail Adults Living in Rural MA
|
N/A | |
Terminated |
NCT04921332 -
Bright Light Therapy for Depression Symptoms in Adults With Cystic Fibrosis (CF) and COPD
|
N/A | |
Completed |
NCT03089515 -
Small Airway Chronic Obstructive Disease Syndrome Following Exposure to WTC Dust
|
N/A | |
Completed |
NCT02787863 -
Clinical and Immunological Efficiency of Bacterial Vaccines at Adult Patients With Bronchopulmonary Pathology
|
Phase 4 | |
Recruiting |
NCT05552833 -
Pulmonary Adaptive Responses to HIIT in COPD
|
N/A | |
Recruiting |
NCT05835492 -
A Pragmatic Real-world Multicentre Observational Research Study to Explore the Clinical and Health Economic Impact of myCOPD
|
||
Recruiting |
NCT05631132 -
May Noninvasive Mechanical Ventilation (NIV) and/or Continuous Positive Airway Pressure (CPAP) Increase the Bronchoalveolar Lavage (BAL) Salvage in Patients With Pulmonary Diseases?
|
N/A | |
Completed |
NCT03244137 -
Effects of Pulmonary Rehabilitation on Cognitive Function in Patients With Severe to Very Severe Chronic Obstructive Pulmonary Disease
|
||
Not yet recruiting |
NCT03282526 -
Volume Parameters vs Flow Parameters in Assessment of Reversibility in Chronic Obstructive Pulmonary Disease
|
N/A | |
Completed |
NCT02546700 -
A Study to Evaluate Safety and Efficacy of Lebrikizumab in Participants With Chronic Obstructive Pulmonary Disease (COPD)
|
Phase 2 | |
Withdrawn |
NCT04446637 -
Acute Bronchodilator Effects of Ipratropium/Levosalbutamol 20/50 mcg Fixed Dose Combination vs Salbutamol 100 mcg Inhaler Plus Ipratropium 20 mcg Inhalation Aerosol Free Combination in Patients With Stable COPD
|
Phase 3 | |
Completed |
NCT04535986 -
A Phase 3 Clinical Trial to Evaluate the Safety and Efficacy of Ensifentrine in Patients With COPD
|
Phase 3 | |
Recruiting |
NCT05865184 -
Evaluation of Home-based Sensor System to Detect Health Decompensation in Elderly Patients With History of CHF or COPD
|
||
Completed |
NCT03256695 -
Evaluate the Relationship Between Use of Albuterol Multidose Dry Powder Inhaler With an eModule (eMDPI) and Exacerbations in Participants With Chronic Obstructive Pulmonary Disease (COPD)
|
Phase 3 | |
Completed |
NCT03295474 -
Telemonitoring in Pulmonary Rehabilitation: Feasibility and Acceptability of a Remote Pulse Oxymetry System.
|
||
Withdrawn |
NCT04042168 -
Implications of Appropriate Use of Inhalers in Chronic Obstructive Pulmonary Disease (COPD)
|
Phase 4 | |
Completed |
NCT03414541 -
Safety And Efficacy Study Of Orally Administered DS102 In Patients With Chronic Obstructive Pulmonary Disease
|
Phase 2 | |
Completed |
NCT02552160 -
DETECT-Register DocumEnTation and Evaluation of a COPD Combination Therapy
|