Status:
COMPLETED
Biomarkers in Chronic Obstructive Pulmonary Disease (COPD)
Lead Sponsor:
Leiden University Medical Center
Conditions:
Chronic Obstructive Pulmonary Disease
Eligibility:
All Genders
40-80 years
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 chro...
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 diagn...
Eligibility Criteria
Inclusion
- 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
- 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).
Key Trial Info
Start Date :
June 1 2010
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
May 1 2011
Estimated Enrollment :
32 Patients enrolled
Trial Details
Trial ID
NCT01145300
Start Date
June 1 2010
End Date
May 1 2011
Last Update
January 26 2012
Active Locations (1)
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1
Department of Pulmonology, Leiden University Medical Center
Leiden, Netherlands, 2333 ZA