Chronic Obstructive Pulmonary DiseaseNCT00898859
Role of A Disintegrin and Metalloproteinase (ADAM) in Epithelial Dysfunction
An observational study of Chronic Obstructive Pulmonary Disease, run by University Medical Center Groningen.
Trial summary
Despite emerging implications for ADAMs (and matrix metalloproteinases (MMPs)) in disease progression, the mechanisms that lead to activation of specific ADAMs (and MMPs) and their actions in chronic obstructive pulmonary disease (COPD) are still incompletely understood. Read more about this study
- Who is it for?
- Ages 40 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Chronic Obstructive Pulmonary Disease
- How many people
- 50 participants
- Where
- No sites listed yet
- Study dates
- May 2009to Dec 2012
- 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 40 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Healthy subjects and subjects with COPD
Who may be able to join
- Age between 40 and 75 years.
- Individuals who currently smoke ≥ 10 cigarettes/day and > 10 pack years.
- Documented FEV1 > 80% predicted, FEV1/FVC > 70%.
- Referred by own physician for a bronchoscopy.
Who cannot join
- Any disease that, as judged by the Investigator, could affect the outcome of this study.
- A respiratory tract infection within 4 weeks of the start of the study.
- History of myocardial infarction or documented myocardial ischemia or the presence of an artificial heart valve.
- Use of anticoagulants.
About this study
Official title: Role of ADAMs in Epithelial Dysregulation in COPD. Differences Between From Non-smokers, Healthy Smokers and Patients With COPD.
Despite emerging implications for ADAMs (and matrix metalloproteinases (MMPs)) in disease progression, the mechanisms that lead to activation of specific ADAMs (and MMPs) and their actions in chronic obstructive pulmonary disease (COPD) are still incompletely understood. In the current study, the researchers aim to investigate the effects of cigarette smoke on cellular parameters that are relevant for development of COPD and the involvement of ADAM activity in these effects. By studying the effects of ADAM inhibition, the researchers aim to provide novel insights in the role of ADAMs in the development of COPD, which may offer new therapeutic targets for the treatment of COPD.
Read the detailed description
Smoking is the largest risk factor for the development of COPD. It has been shown in patients with COPD that smoking induces airway inflammation characterized by bronchial infiltration of neutrophils, macrophages, lymphocytes and mast cells. In addition, smoking accelerates lung function loss and increases bronchial hyperresponsiveness, symptoms, and even mortality in COPD. When inhaled, tobacco smoke first encounters the airway epithelium, which forms a barrier to environmental substances and limits their access to the subepithelial layer. There is suggestive evidence that impaired repair responses and loss of epithelial integrity in the airways play a crucial role in the pathogenesis and contribute to tissue remodeling in COPD. Remodeling of the airway epithelium, e.g., squamous metaplasia and mucous hyperplasia, is often observed in COPD.
Metalloproteases (MMPs) and A Disintegrin and Metalloproteinase (ADAM)s may play an important role in respiratory diseases. MMPs and ADAMs, a class of membrane-bound MMPs, form a family of enzymes involved in degrading extracellular matrix (ECM) components. Their proteolytic activity is involved in remodeling of the ECM, which is required for migration and repair processes and regulated tissue turn-over. However, aberrant activity can lead to tissue destruction and irreversible damage. Thus MMPs, and ADAMs may play an important role in respiratory diseases and a protease-antiprotease imbalance may contribute to airway remodeling and impaired epithelial repair in COPD. In addition, MMPs/ADAMs act in regulatory events in inflammation and airway remodeling by liberating adhesion molecules and shedding of growth factors and cytokines from the cell surface. Furthermore, ADAMs play a role in cell-cell and cell-matrix interactions by their so-called disintegrin domain. In epithelial cells, both MMPs and ADAMs are known to regulate intercellular contacts, cell-matrix contacts, migratory responses, shedding of cytokines/growth factors, and intracellular signaling pathways. Since increased MMP levels (e.g., MMP-9, 12) have been observed during COPD exacerbations and polymorphisms in specific ADAM genes (i.e., ADAM33) have been associated with COPD susceptibility, the activation of MMPs and ADAMs on the airway epithelium may play an important role in the pathogenesis of COPD. Reactive oxygen species present in cigarette smoke may activate Duox, leading to activation of ADAM17 in airway epithelial cells. ADAM17 has been described to be involved in the release of growth factors (TGF-α), leading to the release of proinflammatory cytokines (IL-8) and production of MUC5AC 10-13. TGF-α acts on the EGF receptor (EGFR), which is involved in the production of MUC5AC and goblet cell hyperplasia. IL-8 is a well-known chemo-attractant for neutrophils, and thus may play a central role in neutrophilic inflammation in COPD, leading to ROS production, the release of neutrophil elastase and emphysema.
Despite emerging implications for ADAMs (and MMPs) in disease progression, the mechanisms that lead to activation of specific ADAMs (and MMPs) and their actions in COPD are still incompletely understood. In the current study, we aim to investigate the effects of cigarette smoke on cellular parameters that are relevant for development of COPD and the involvement of ADAM activity in these effects. By studying the effects of ADAM inhibition, we aim to provide novel insights in the role of ADAMs in the development of COPD, which may offer new therapeutic targets for the treatment of COPD.
- Conditions
- Chronic Obstructive Pulmonary Disease
- Keywords
- ADAM, epithelial, COPD
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive
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 |
|---|---|---|
| 1 | Healthy, non-smoking | |
| 2 | healthy, ex-smoking | |
| 3 | healthy, current-smokers | |
| 4 | COPD, ex-smokers | |
| 5 | COPD, smokers |
What is being measured
The primary outcome is the main question the study is designed to answer.
IL8-production
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 May 2009 (estimated)
- Study startMay 2009
- Primary completionMay 2012
- Study completionDec 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Obstructive Pulmonary DiseaseStudies of the same condition, open and under way.
- More trials run by University Medical Center GroningenThe sponsor's other registered studies.
- 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
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Medical Center Groningen
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Maarten van den Berge, University Medical Center Groningen
- Investigators
- Maarten van den Berge, PhD, Study chair, University Medical Center Groningenmaarrten van den Berge, PhD, Study director, University Medical Center GroningenIrene Heijink, PhD, Principal investigator, University Medical Center Groningen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00898859
- Sponsor's protocol ID
- METc2009086
- Status last verified
- Jan 2015
- First submitted
- 11 May 2009
- Last updated
- 16 Jan 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Jan 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Role of ADAMs in Epithelial Dysregulation in COPD. Differences Between From Non-smokers, Healthy Smokers and Patients With COPD.
- ClinicalTrials.gov ID
- NCT00898859
- Acronym / sponsor ID
- METc2009086
- Conditions
- Chronic Obstructive Pulmonary Disease
- Keywords
- ADAM, epithelial, COPD
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- University Medical Center GroningenUniversity, hospital or other
- Study start
- May 2009
- Primary completion
- May 2012 (actual)
- Study completion
- Dec 2012 (actual)
- First posted
- 12 May 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.
Despite emerging implications for ADAMs (and matrix metalloproteinases (MMPs)) in disease progression, the mechanisms that lead to activation of specific ADAMs (and MMPs) and their actions in chronic obstructive pulmonary disease (COPD) are still incompletely understood. In the current study, the researchers aim to investigate the effects of cigarette smoke on cellular parameters that are relevant for development of COPD and the involvement of ADAM activity in these effects. By studying the effects of ADAM inhibition, the researchers aim to provide novel insights in the role of ADAMs in the development of COPD, which may offer new therapeutic targets for the treatment of COPD.
Detailed description
Smoking is the largest risk factor for the development of COPD. It has been shown in patients with COPD that smoking induces airway inflammation characterized by bronchial infiltration of neutrophils, macrophages, lymphocytes and mast cells. In addition, smoking accelerates lung function loss and increases bronchial hyperresponsiveness, symptoms, and even mortality in COPD. When inhaled, tobacco smoke first encounters the airway epithelium, which forms a barrier to environmental substances and limits their access to the subepithelial layer. There is suggestive evidence that impaired repair responses and loss of epithelial integrity in the airways play a crucial role in the pathogenesis and contribute to tissue remodeling in COPD. Remodeling of the airway epithelium, e.g., squamous metaplasia and mucous hyperplasia, is often observed in COPD.
Metalloproteases (MMPs) and A Disintegrin and Metalloproteinase (ADAM)s may play an important role in respiratory diseases. MMPs and ADAMs, a class of membrane-bound MMPs, form a family of enzymes involved in degrading extracellular matrix (ECM) components. Their proteolytic activity is involved in remodeling of the ECM, which is required for migration and repair processes and regulated tissue turn-over. However, aberrant activity can lead to tissue destruction and irreversible damage. Thus MMPs, and ADAMs may play an important role in respiratory diseases and a protease-antiprotease imbalance may contribute to airway remodeling and impaired epithelial repair in COPD. In addition, MMPs/ADAMs act in regulatory events in inflammation and airway remodeling by liberating adhesion molecules and shedding of growth factors and cytokines from the cell surface. Furthermore, ADAMs play a role in cell-cell and cell-matrix interactions by their so-called disintegrin domain. In epithelial cells, both MMPs and ADAMs are known to regulate intercellular contacts, cell-matrix contacts, migratory responses, shedding of cytokines/growth factors, and intracellular signaling pathways. Since increased MMP levels (e.g., MMP-9, 12) have been observed during COPD exacerbations and polymorphisms in specific ADAM genes (i.e., ADAM33) have been associated with COPD susceptibility, the activation of MMPs and ADAMs on the airway epithelium may play an important role in the pathogenesis of COPD. Reactive oxygen species present in cigarette smoke may activate Duox, leading to activation of ADAM17 in airway epithelial cells. ADAM17 has been described to be involved in the release of growth factors (TGF-α), leading to the release of proinflammatory cytokines (IL-8) and production of MUC5AC 10-13. TGF-α acts on the EGF receptor (EGFR), which is involved in the production of MUC5AC and goblet cell hyperplasia. IL-8 is a well-known chemo-attractant for neutrophils, and thus may play a central role in neutrophilic inflammation in COPD, leading to ROS production, the release of neutrophil elastase and emphysema.
Despite emerging implications for ADAMs (and MMPs) in disease progression, the mechanisms that lead to activation of specific ADAMs (and MMPs) and their actions in COPD are still incompletely understood. In the current study, we aim to investigate the effects of cigarette smoke on cellular parameters that are relevant for development of COPD and the involvement of ADAM activity in these effects. By studying the effects of ADAM inhibition, we aim to provide novel insights in the role of ADAMs in the development of COPD, which may offer new therapeutic targets for the treatment of COPD.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| 1 | – | –Healthy, non-smoking |
| 2 | – | –healthy, ex-smoking |
| 3 | – | –healthy, current-smokers |
| 4 | – | –COPD, ex-smokers |
| 5 | – | –COPD, smokers |
Who may qualify
- Ages
- 40 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Healthy subjects and subjects with COPD
Key inclusion criteria (4 listed)
- Age between 40 and 75 years.
- Individuals who currently smoke ≥ 10 cigarettes/day and > 10 pack years.
- Documented FEV1 > 80% predicted, FEV1/FVC > 70%.
- Referred by own physician for a bronchoscopy.
Key exclusion criteria (4 listed)
- Any disease that, as judged by the Investigator, could affect the outcome of this study.
- A respiratory tract infection within 4 weeks of the start of the study.
- History of myocardial infarction or documented myocardial ischemia or the presence of an artificial heart valve.
- Use of anticoagulants.
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
IL8-production
Time frame: 12 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jan 2015.
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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.
Maarten van den Berge, PhD study chair
University Medical Center Groningen
maarrten van den Berge, PhD study director
University Medical Center Groningen
Irene Heijink, PhD principal investigator
University Medical Center Groningen
Questions about this trial
What is this clinical trial studying?
An observational study of Chronic Obstructive Pulmonary Disease, run by University Medical Center Groningen.
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 4 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: finished, as of the sponsor's last update on 16 Jan 2015. Status can change between updates, so confirm with the study contact before making plans.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
IL8-production (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 16 Jan 2015.