Chronic Obstructive Pulmonary DiseaseNCT00850863
Systemic Inflammation in Chronic Obstructive Pulmonary Disease (COPD)
An observational study of Chronic Obstructive Pulmonary Disease, run by Top Institute Pharma at 1 site in Netherlands.
Trial 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 insight is needed to design effective anti-inflammatory agents. Read more about this study
- Who is it for?
- Ages 18 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Chronic Obstructive Pulmonary Disease
- Type of treatment
- Injection or infusion
- How many people
- 240 participants
- Where
- 1 siteNetherlands
- Study dates
- Feb 2009to Jan 2015
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Healthy individuels and COPD patients. For detail description see Groups/Cohorts.
Who may be able to join
- Age ≥18 and ≤75 years
- 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
Who cannot join
- 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, 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
Trial locations and contacts
1 site in 1 country.
Netherlands1 site, 1 recruiting
- Recruiting
University Medical Center Utrecht
Utrecht, Utrecht, 3508GA
Leo Koenderman, Dr. Prof, +31 88 7557255, l.koenderman@umcutrecht.nl
Jan-Willem Lammers, Dr. Prof. MD
About this study
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 Therapy (Study 2).
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:
- 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
- Conditions
- Chronic Obstructive Pulmonary Disease
- Keywords
- COPD, Inflammation, Smoking, Susceptibility
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive, Inflammation, Smoking, Disease Susceptibility
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| A | 20 healthy individuals not susceptible for COPD (age 18-40 years, 0 < pack years > 10, FEV1/FVC >70% , FEV1 >85% predicted) | |
| B | 30 healthy individuals susceptible for COPD (age 40-75years, pack years >20, FEV1/FVC > 70%, FEV1 > 85% predicted) | |
| 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 | |
| D1 | 30 COPD patients with GOLD stage I (age 40-75 years, Pack years > 10, FEV1/FVC ≤ 70%, FEV1 > 80% predicted) | |
| D2 | 30 COPD patients with GOLD stage II (age 40-75 years, Pack years > 10, FEV1/FVC ≤ 70%, FEV1 50-80 predicted) | |
| D3 | 30 COPD patients with GOLD stage III (age 40-75 years, Pack years > 10, FEV1/FVC ≤ 70%, FEV1 30-50% predicted) | |
| D4 | 30 COPD patients with GOLD stage IV (age 40-75 years,Pack years > 10, FEV1/FVC ≤ 70%, FEV1 30% predicted) | |
| 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 | |
| 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) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 4 years
Secondary outcomes (3)
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.
Measured: 4 years
Important clinical endpoints include symptoms, lung function, Bode-index, CT-scanning of the lung.
Measured: 4 years
Distribution of candidate genes (SNPs) for COPD between the different groups and relations with systemic inflammation.
Measured: 4 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Feb 2009 (estimated)
- Study startFeb 2009
- Primary completionJan 2013 (estimated)
- Study completionJan 2015 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Chronic Obstructive Pulmonary DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 240 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Top Institute Pharma
- Sponsor type
- University, hospital or other
- Collaborators
- Academisch Ziekenhuis Maastricht, University Medical Center Groningen, UMC Utrecht, GlaxoSmithKline, Nycomed
- Investigators
- Jan-Willem Lammers, Dr. Prof. MD, Principal investigator, UMC Utrecht
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00850863
- Sponsor's protocol ID
- 23437
- Status last verified
- Feb 2009
- First submitted
- 24 Feb 2009
- Last updated
- 25 Feb 2009
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 27117828Hoonhorst 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.
PubMed 24622644Lo 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.
PubMed 23377993
Study at a glance
From the registry record, last updated by the sponsor on 25 Feb 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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 Therapy (Study 2).
- ClinicalTrials.gov ID
- NCT00850863
- Acronym / sponsor ID
- 23437
- Conditions
- Chronic Obstructive Pulmonary Disease
- Keywords
- COPD, Inflammation, Smoking, Susceptibility
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 240 participants (estimated)
- Lead sponsor
- Top Institute PharmaUniversity, hospital or other
- Collaborators
- Academisch Ziekenhuis Maastricht, University Medical Center Groningen, UMC Utrecht, GlaxoSmithKline, Nycomed
- Study start
- Feb 2009
- Primary completion
- Jan 2013 (estimated)
- Study completion
- Jan 2015 (estimated)
- First posted
- 25 Feb 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- 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
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 9
| Arm | Type | Receives |
|---|---|---|
| A | – | –20 healthy individuals not susceptible for COPD (age 18-40 years, 0 < pack years > 10, FEV1/FVC >70% , FEV1 >85% predicted) |
| B | – | –30 healthy individuals susceptible for COPD (age 40-75years, pack years >20, FEV1/FVC > 70%, FEV1 > 85% predicted) |
| 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 |
| D1 | – | –30 COPD patients with GOLD stage I (age 40-75 years, Pack years > 10, FEV1/FVC ≤ 70%, FEV1 > 80% predicted) |
| D2 | – | –30 COPD patients with GOLD stage II (age 40-75 years, Pack years > 10, FEV1/FVC ≤ 70%, FEV1 50-80 predicted) |
| D3 | – | –30 COPD patients with GOLD stage III (age 40-75 years, Pack years > 10, FEV1/FVC ≤ 70%, FEV1 30-50% predicted) |
| D4 | – | –30 COPD patients with GOLD stage IV (age 40-75 years,Pack years > 10, FEV1/FVC ≤ 70%, FEV1 30% predicted) |
| 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 |
| 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) |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Healthy individuels and COPD patients. For detail description see Groups/Cohorts.
Key inclusion criteria (4 listed)
- Age ≥18 and ≤75 years
- 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
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
Time frame: 4 years
3 secondary outcomes
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.
Time frame: 4 years
Important clinical endpoints include symptoms, lung function, Bode-index, CT-scanning of the lung.
Time frame: 4 years
Distribution of candidate genes (SNPs) for COPD between the different groups and relations with systemic inflammation.
Time frame: 4 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Feb 2009.
- Derived from this study: PubMed 27117828Hoonhorst 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.
- Derived from this study: PubMed 24622644Hoonhorst 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.
- Derived from this study: PubMed 23377993Lo 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.
Related trials for Chronic Obstructive Pulmonary Disease
Enrolling by invitationObservational study
Firefighter's Longitudinal Airway and Respiratory Exposome/Multiome Study (FLARES)
Anosmia, Chronic Obstructive Pulmonary Disease
RecruitingPhase 3
A Study to Evaluate Axatilimab and Corticosteroids as Initial Treatment for Chronic Graft-Versus-Host Disease
Chronic Graft-versus-host-disease
Not yet recruiting
Impact of Multidisciplinary Care, Structured and Targeted on the COPD Patient's Clinical Pathway.
Chronic Obstructive Pulmonary Disease, Lung Diseases, Obstructive
Not yet recruitingPhase 3
The AIRWARD Study: A Study to Test Whether Verducatib Helps People With Chronic Obstructive Pulmonary Disease
Chronic Obstructive Pulmonary Disease
Not yet recruiting
Evaluating and Promoting Resilience in Adolescents With Tourette Syndrome
Tourette Syndrome, Tic Disorders
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jan-Willem Lammers, Dr. Prof. MD principal investigator
UMC Utrecht
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Chronic Obstructive Pulmonary Disease, run by Top Institute Pharma at 1 site in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 25 Feb 2009. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Leo Koenderman, Dr. Prof. (+31 88 7557255, l.koenderman@umcutrecht.nl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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 (time frame: 4 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00850863, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Feb 2009.