Status:
UNKNOWN
Responses Induced by Smoking in Individuals Being Susceptible and Non-Susceptible for Development of COPD
Lead Sponsor:
Top Institute Pharma
Collaborating Sponsors:
University Medical Center Groningen
UMC Utrecht
Conditions:
Chronic Obstructive Pulmonary Disease
Eligibility:
All Genders
18-75 years
Brief Summary
COPD is ranked number 3 by the WHO list of important diseases worldwide and is the only disease with increasing mortality. The pathogenesis of cigarette smoke-induced COPD is obscure, therefore more i...
Detailed Description
Primary study parameters/outcome of the study: * Local inflammation before and after cigarette smoking assessed by exhaled breath condensate, microprobe sampling and bronchial biopsies. * Systemic in...
Eligibility Criteria
Inclusion
- Age 18-75 years
- Age, pack years, FEV1/FVC and FEV1% predicted must fit in one of the 5 groups described above.
- Able to stop smoking for 10 days and start smoking 3-4 cigarettes within 1 hour
- 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, gastro-enteritis etc
- Pulmonary diseases like sarcoidosis, IPF, silicosis, hypersensitivity pneumonitis
- Life threatening diseases like carcinoma, AIDS (including HIV+), acute leukaemia etc
- Medication that may affect the results of the study: NSAID's, immunosuppressive agents like prednisolon, metotrexate, azathioprine,Acenocoumarol
Key Trial Info
Start Date :
January 1 2009
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
January 1 2015
Estimated Enrollment :
120 Patients enrolled
Trial Details
Trial ID
NCT00807469
Start Date
January 1 2009
End Date
January 1 2015
Last Update
December 12 2008
Active Locations (1)
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1
Universitair Medisch Centrum Groningen
Groningen, Provincie Groningen, Netherlands, 9713 GZ