Biomarkers in Chronic Obstructive Pulmonary Disease (COPD)

NCT01145300 | Completed

• 1 other identifier: P10.045
• Study Type: observational
• Target: 32
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Chronic Obstructive Pulmonary Disease

Keywords

COPD; Inflammation; Small airways

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (3)

• Expression of the 1,25(OH)2D3 degrading enzyme CYP24A1 and antimicrobial peptides in small and large airways

  within 1 week after surgery

• Markers in exhaled breath

  1 week before and 3 months after surgery

• Expression of macrophage markers (Mf1 and Mf2) and chymase/tryptase in mast cell subsets

  within 1 week after surgery

Eligibility Criteria

• Age: 40 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with and without COPD scheduled for lung resection for lung cancer.

You may qualify if:

• 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• Leiden University Medical Center: lead

Study Sites (1)

Department of Pulmonology, Leiden University Medical Center

Leiden, 2333 ZA, Netherlands

Location

Biospecimen

Retention: SAMPLES WITH DNA

blood

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive; Inflammation

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Klaus F. Rabe, MD, PhD

  Leiden University Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: June 14, 2010
• First Posted: June 16, 2010
• Study Start: June 1, 2010
• Primary Completion: May 1, 2011
• Study Completion: May 1, 2011
• Last Updated: January 26, 2012

Record last verified: 2012-01

Locations

NL (1)