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Sponsors and Collaborators: |
Top Institute Pharma University Medical Centre Groningen UMC Utrecht GlaxoSmithKline Nycomed |
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Information provided by: | Top Institute Pharma |
ClinicalTrials.gov Identifier: | NCT00807469 |
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 insight is needed to design effective anti-inflammatory agents. We hypothesize that healthy individuals who are susceptible to smoking demonstrate a higher and aberrant inflammatory response to cigarette smoke. This susceptibility is caused by heterogeneous factors and is associated with various polymorphic genes that interact with each other and with the environment.
Objective:
Condition |
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Chronic Obstructive Pulmonary Disease |
Study Type: | Observational |
Study Design: | Case Control, Prospective |
Official Title: | Acute and Chronic Inflammatory Responses Induced by Smoking in Individuals Being Susceptible and Non-Susceptible for Development of COPD: From Specific Disease Phenotyping Towards Novel Made Therapy (Study 1) |
Blood will be retained to investigate diffences in candidate genes (SNPs) for COPD between the 5 different groups.
Estimated Enrollment: | 120 |
Study Start Date: | January 2009 |
Estimated Study Completion Date: | January 2015 |
Estimated Primary Completion Date: | January 2013 (Final data collection date for primary outcome measure) |
Groups/Cohorts |
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1
20 healthy individuals not susceptible for COPD (age 18-40 years, >0>10 packyears, FEV1/VC >70%, FEV1 >85% predicted)
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2
20 healthy individuals susceptible for COPD (age 18-40 years >20 packyears, FEV1/VC >70%, FEV1 >85% predicted) and high prevalence of COPD in smoking family members older than 45 years
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3
20 healthy individuals very susceptible for COPD (age 18-40 years, > 0 > 10 packyears, FEV1/VC >70%, FEV1 >85% predicted), and one of the smoking family members has severe early onset COPD or mild COPD with very low smoke exposure
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4
30 healthy individuals not susceptible for COPD (age 40-75 years, >20 packyears, FEV1/VC >70%, FEV1 >85% predicted)
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5
30 COPD patients with GOLD stage II (age 40-75 years, >10 packyears, FEV1/VC <_70%, FEV1 50-80% predicted)
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Primary study parameters/outcome of the study:
Ages Eligible for Study: | 18 Years to 75 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | Yes |
Sampling Method: | Non-Probability Sample |
healthy individuals and COPD patients with GOLD stage II. For detailed describtion see studie cohorts.
Inclusion Criteria:
Exclusion Criteria:
Contact: Nick Ten Hacken, MD | +3150-3614574 | N.H.T.ten.Hacken@int.umcg.nl |
Netherlands | |
Universitair Medisch Centrum Groningen | |
Groningen, Netherlands, 9713 GZ |
Principal Investigator: | Dirkje Postma, Dr. Prof. MD | UMCG |
Responsible Party: | Pulmonary Department UMCG Groningen, Postbus 9700 RB Groningen ( Professor Dr DS Postma ) |
Study ID Numbers: | 23440 |
Study First Received: | December 11, 2008 |
Last Updated: | December 11, 2008 |
ClinicalTrials.gov Identifier: | NCT00807469 History of Changes |
Health Authority: | Netherlands: Medical Ethics Review Committee (METC) |
COPD smoking susceptibility inflammation genetic |
Smoking Lung Diseases, Obstructive Respiratory Tract Diseases Disease Susceptibility |
Lung Diseases Genetic Predisposition to Disease Inflammation Pulmonary Disease, Chronic Obstructive |
Lung Diseases, Obstructive Respiratory Tract Diseases Lung Diseases Pulmonary Disease, Chronic Obstructive |