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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 Therapy (Study 2).
Sponsor study identifier
observational
240
1 country
1
Study Start
February 2009
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
January 2013
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
January 2015
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
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. Recently it has become clear that cigarette smoke-induced inflammation is not only present in the lungs but also in the blood, and that this systemic inflammation has important consequences for the clinical expression of COPD. The investigators hypothesize that healthy individuals who are susceptible to cigarette smoking demonstrate a higher and aberrant systemic 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:
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
January 2015
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
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Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
February 2009
Date type not reportedThis date has not been verified as actual or estimated.
February 24, 2009
Actual (reported)February 25, 2009
Actual (reported)January 2013
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
January 2015
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Systemic inflammation assessed by measurement of expression of established and newly developed markers on innate immune cells; genomic and proteomic analysis of innate immune cells and measurement of pro- and anti-inflammatory cytokines in plasma/serum
4 years
Extensive clinical characterisation of: a) young healthy individuals with low number of pack years who have a high and low familial risk to develop COPD; b) older individuals with higher number of pack years with either a normal lung function or COPD.
4 years
Important clinical endpoints include symptoms, lung function, Bode-index, CT-scanning of the lung.
4 years
Distribution of candidate genes (SNPs) for COPD between the different groups and relations with systemic inflammation.
4 years
20 healthy individuals not susceptible for COPD (age 18-40 years, 0 \< pack years \> 10, FEV1/FVC \>70% , FEV1 \>85% predicted)
30 healthy individuals susceptible for COPD (age 40-75years, pack years \>20, FEV1/FVC \> 70%, FEV1 \> 85% predicted)
20 healthy individuals very susceptible for COPD (age 18-40 year, 0 \< pack years \> 10, FEV1/FVC \> 70%, FEV1 \> 85% predicted)and high prevalance of COPD in smoking family members older than 45 years
30 COPD patients with GOLD stage I (age 40-75 years, Pack years \> 10, FEV1/FVC ≤ 70%, FEV1 \> 80% predicted)
30 COPD patients with GOLD stage II (age 40-75 years, Pack years \> 10, FEV1/FVC ≤ 70%, FEV1 50-80 predicted)
30 COPD patients with GOLD stage III (age 40-75 years, Pack years \> 10, FEV1/FVC ≤ 70%, FEV1 30-50% predicted)
30 COPD patients with GOLD stage IV (age 40-75 years,Pack years \> 10, FEV1/FVC ≤ 70%, FEV1 30% predicted)
Healthy individuels and COPD patients. For detail description see Groups/Cohorts.
University Medical Center Utrecht
Utrecht, Utrecht, 3508GA, Netherlands
Hoonhorst SJ, Lo Tam Loi AT, Pouwels SD, Faiz A, Telenga ED, van den Berge M, Koenderman L, Lammers JW, Boezen HM, van Oosterhout AJ, Lodewijk ME, Timens W, Postma DS, Ten Hacken NH. Advanced glycation endproducts and their receptor in different body compartments in COPD. Respir Res. 2016 Apr 26;17:46. doi: 10.1186/s12931-016-0363-2.
Hoonhorst SJ, ten Hacken NH, Lo Tam Loi AT, Koenderman L, Lammers JW, Telenga ED, Boezen HM, van den Berge M, Postma DS. Lower corticosteroid skin blanching response is associated with severe COPD. PLoS One. 2014 Mar 12;9(3):e91788. doi: 10.1371/journal.pone.0091788. eCollection 2014.
Jan-Willem Lammers, Dr. Prof. MD
UMC Utrecht
First Submitted
February 24, 2009
First Posted
February 25, 2009
Study Start
February 2009
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
January 2013
Estimated (date passed)20 healthy individuels very susceptible for COPD ( Age 18-40 years,0 \< Pack years \> 10, FEV1/FVC \>70%, FEV1 \> 85% predicted, and one of the smoking family members has severe early onset COPD or mild COPD with very low smoke exposure
30 COPD patients who are highly susceptible (age \> 53 years with Pack years \> 10 , FEV1/FVC ≤ 70% and FEV1 \< 40% predicted) or (age \>18 years with 0 \< pack years \> 5, FEV1/FVC ≤ 70% and FEV1 \< 80% predicted)
Contact the study team to confirm eligibility.
Lo Tam Loi AT, Hoonhorst SJ, Franciosi L, Bischoff R, Hoffmann RF, Heijink I, van Oosterhout AJ, Boezen HM, Timens W, Postma DS, Lammers JW, Koenderman L, Ten Hacken NH. Acute and chronic inflammatory responses induced by smoking in individuals susceptible and non-susceptible to development of COPD: from specific disease phenotyping towards novel therapy. Protocol of a cross-sectional study. BMJ Open. 2013 Feb 1;3(2):e002178. doi: 10.1136/bmjopen-2012-002178. Print 2013.
This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
January 2015
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Last Updated
February 25, 2009
Record last verified: 2009-02
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