Systemic Inflammation in Chronic Obstructive Pulmonary Disease (COPD)
NCT ID: NCT00850863
Last Updated: 2009-02-25
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
240 participants
OBSERVATIONAL
2009-02-28
2015-01-31
Brief Summary
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Objective:
* To study systemic inflammation in individuals who are or are not susceptible to develop COPD.
* To characterize the switch to chronicity of the systemic inflmmatory response in COPD
* To determine whether the type and severity of the systemic inflammation contributes to the clinical outcome of COPD
* To compare between subjects who are or are not susceptible to develop COPD in peripheral blood, the corticosteroid responsiveness in vitro, and to unravel underlying mechanisms.
* To study the role of candidate genes that may play a role in the development of fixed airway obstruction, and to identify clues for patient's responsiveness to specific drugs
* To develop new biological and clinical markers for the early diagnosis and monitoring of COPD
* To define possible mediators involved in the early induction of COPD in susceptible smokers, and to define new drug targets
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Detailed Description
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Conditions
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Study Design
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CASE_CONTROL
PROSPECTIVE
Study Groups
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A
20 healthy individuals not susceptible for COPD (age 18-40 years, 0 \< pack years \> 10, FEV1/FVC \>70% , FEV1 \>85% predicted)
No interventions assigned to this group
B
30 healthy individuals susceptible for COPD (age 40-75years, pack years \>20, FEV1/FVC \> 70%, FEV1 \> 85% predicted)
No interventions assigned to this group
C
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
No interventions assigned to this group
D1
30 COPD patients with GOLD stage I (age 40-75 years, Pack years \> 10, FEV1/FVC ≤ 70%, FEV1 \> 80% predicted)
No interventions assigned to this group
D2
30 COPD patients with GOLD stage II (age 40-75 years, Pack years \> 10, FEV1/FVC ≤ 70%, FEV1 50-80 predicted)
No interventions assigned to this group
D3
30 COPD patients with GOLD stage III (age 40-75 years, Pack years \> 10, FEV1/FVC ≤ 70%, FEV1 30-50% predicted)
No interventions assigned to this group
D4
30 COPD patients with GOLD stage IV (age 40-75 years,Pack years \> 10, FEV1/FVC ≤ 70%, FEV1 30% predicted)
No interventions assigned to this group
E
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
No interventions assigned to this group
F
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)
No interventions assigned to this group
Eligibility Criteria
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Inclusion Criteria
* Age, pack years, FEV1/FVC and FEV1% predicted must fit in one of the 9 groups of the study population
* Physically and mentally able to undergo the total study protocol
* Written informed consent
Exclusion Criteria
* 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, pulmonary fibrosis, silicosis, hypersensitivity pneumonitis, asthma
* 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
18 Years
75 Years
ALL
Yes
Sponsors
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Academisch Ziekenhuis Maastricht
OTHER
University Medical Center Groningen
OTHER
UMC Utrecht
OTHER
GlaxoSmithKline
INDUSTRY
Nycomed
INDUSTRY
Top Institute Pharma
OTHER
Responsible Party
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University Medical Center Utrecht
Principal Investigators
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Jan-Willem Lammers, Dr. Prof. MD
Role: PRINCIPAL_INVESTIGATOR
UMC Utrecht
Locations
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University Medical Center Utrecht
Utrecht, Utrecht, Netherlands
Countries
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Central Contacts
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Facility Contacts
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References
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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.
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.
Other Identifiers
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23437
Identifier Type: -
Identifier Source: org_study_id
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