Status:
UNKNOWN
Multiorgan Pathology in Chronic Obstructive Pulmonary Disease (COPD)
Lead Sponsor:
Top Institute Pharma
Collaborating Sponsors:
University Medical Center Groningen
Maastricht University Medical Center
Conditions:
Chronic Obstructive Pulmonary Disease
Eligibility:
All Genders
40-75 years
Brief Summary
There is increasing evidence in the literature that COPD should not be considered as a localised pulmonary disorder but as a systemic disease involving pathology in several extra pulmonary tissues. We...
Detailed Description
Primary study parameters/outcome of the study: 1. Smoking history and behaviour, diet and physical activity level assessed by questionnaire 2. Extensive lung function and CT scanning of the lung, ECG...
Eligibility Criteria
Inclusion
- Age 40-75 years
- Age, pack years, FEV1/FVC and FEV1% predicted must fit in one of 2 groups of table 4.3
- Physically and mentally able to undergo the total study protocol
- Written informed consent
Exclusion
- Participation in another study
- Alpha-1-antitrypsin deficiency
- Selected grade 1-3 co-morbidity listed in the ACE-27
- Active pulmonary infection like tuberculosis, pneumonia, flue, tracheobronchitis
- Active extra-pulmonary infection like hepatitis A-C, cystitis, gastroenteritis etc.
- Pulmonary diseases like sarcoidosis, IPF, silicosis, hypersensitivity pneumonitis, asthma
- Life threatening diseases like carcinoma, AIDS (including HIV+), acute leukemia etc.
- Medication that may affect the results of the study: NSAID's, immunosuppressive agents like prednisolon, methotrexate, azathioprine, sintrom tablets, askal
- Antibiotic or prednisolon use in the past 2 months
Key Trial Info
Start Date :
September 1 2010
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
April 1 2015
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT00864994
Start Date
September 1 2010
End Date
April 1 2015
Last Update
March 29 2010
Active Locations (1)
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1
Maastricht University Medical Center, Dept. of Respiratory Medicine
Maastricht, Limburg, Netherlands, 6200 MD