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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.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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.

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 groups in NCT00898859
Study groupRoleWhat they receive
1Healthy, non-smoking
2healthy, ex-smoking
3healthy, current-smokers
4COPD, ex-smokers
5COPD, smokers

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

  1. First posted12 May 2009 (estimated)
  2. Study startMay 2009
  3. Primary completionMay 2012
  4. Study completionDec 2012

Resources

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)
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

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.

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