Chronic Obstructive Pulmonary DiseaseNCT00298402
Macrophages in Smokers' Lung
An observational study of Chronic Obstructive Pulmonary Disease and Emphysema, run by Imperial College London at 1 site in United Kingdom.
Trial summary
Cigarette smoking causes an increase in inflammation in the lungs. In about 20% of smokers this inflammation leads to damage in lungs including making holes in the lung tissue. This damage can not be repaired and these people find it very difficult to breathe. Read more about this study
- Who is it for?
- Ages 21 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Chronic Obstructive Pulmonary Disease, Emphysema, Chronic Bronchitis
- How many people
- 0 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Oct 2005to Oct 2007
- 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 21 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- All healthy smoking volunteers in trials will meet the following criteria:
- Age 21-70 years. Smoking history of at least 10 pack years. (1 pack year = 20 cigarettes per day for 1 year).
- No history of respiratory or allergic disease. Normal baseline spirometry as predicted for age, sex and height. No history of upper respiratory tract infection in the preceding six weeks. Not taking regular medication -
Who cannot join
- Subjects will not included in this study if they meet any of the following exclusion criteria:
- Clinically significant findings in the medical history or on physical examination.
- Pregnant women or mothers who are breastfeeding. Subjects who are unable to give informed consent -
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Role of Macrophages in the Pathophysiology of Smokers' Lung
Cigarette smoking causes an increase in inflammation in the lungs. In about 20% of smokers this inflammation leads to damage in lungs including making holes in the lung tissue. This damage can not be repaired and these people find it very difficult to breathe. One of the problems with this disease called chronic obstructive pulmonary disease, or COPD for short, is that by the time patients visit their doctor with symptoms, the damage has already been done. At the moment, there is no way to predict which smokers will go on to develop COPD. The aim of this research is to look at smokers who breathe normally and use an imaging technique called a CT scan, to look at their lungs in more detail. Some of these people will have spots on their scan which may be caused by inflammation. We want to look at the cells at these spots to see if they make more proteins and enzymes that cause lung damage when compared to people that do not have these spots. We would then be able to predict which smokers are likely to develop COPD and treat them early before they have damaged their lungs.
Read the detailed description
Chronic obstructive pulmonary disease, or COPD for short, will be 3rd biggest killer in the world by 2020. The major cause of this disease is cigarette smoking, but only about 15-20% of smokers will develop COPD. In this disease, the lung becomes damaged and patients can not breathe properly. This damage can not be repaired therefore at the moment there are no good treatements for COPD. By the time a patient visits their doctor with symptoms the damage is already done. Therefore in this study we want to look at the lungs of smokers that feel well and can breathe normally. We believe that much of the damage to the lung in COPD is caused by inflammation. In particular, there are more inflammatory cells called macrophages in the lungs of these patients. These macrophages normally protect the lung when we inhale particles like dust and are also inportant to fight infections. In COPD, these macrophages are out of control and produce huge amounts of enzymes that break down lung tissue and more proteins that cause inflammation. We want to see if we can find these macrophages in the lungs of smokers before they get COPD. Recently, a 5 and a half year study showed that some smokers that can breathe normally have increased inflammation in their lungs. This can be seen using a scan called a CT scan. On the CT scan, these areas look like spots. When these smokers had another scan 5 and half years later, in some cases these spots had become holes in their lung. This is called emphysema and is one of the characteristics of COPD. We want to know whether the macrophages in these smokers cause this damage. If this is the case, we have two separate findings from this study. Firstly, we could look at macrophages and predict which smokers will develop COPD and secondly, try and develop new treatments to stop the macrophages from producing all proteins that cause inflammation.
- Keywords
- macrophage, MMP, CT scan
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive, Emphysema, Bronchitis, Chronic
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Mar 2006 (estimated)
- Study startOct 2005
- Study completionOct 2007
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 Imperial College LondonThe 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
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Imperial College London
- Sponsor type
- University, hospital or other
- Collaborators
- Royal Brompton & Harefield NHS Foundation Trust
- Investigators
- Athol Wells, MD, Principal investigator, Royal Brompton & Harefield NHS Foundation Trust
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00298402
- Sponsor's protocol ID
- 05/Q0404/87
- Status last verified
- Mar 2006
- First submitted
- 1 Mar 2006
- Last updated
- 28 May 2015
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 May 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Role of Macrophages in the Pathophysiology of Smokers' Lung
- ClinicalTrials.gov ID
- NCT00298402
- Acronym / sponsor ID
- 05/Q0404/87
- Keywords
- macrophage, MMP, CT scan
- Study type
- Observational
- Recruitment status
- Withdrawn
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Imperial College LondonUniversity, hospital or other
- Collaborators
- Royal Brompton & Harefield NHS Foundation Trust
- Study start
- Oct 2005
- Study completion
- Oct 2007
- First posted
- 2 Mar 2006 (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.
Cigarette smoking causes an increase in inflammation in the lungs. In about 20% of smokers this inflammation leads to damage in lungs including making holes in the lung tissue. This damage can not be repaired and these people find it very difficult to breathe. One of the problems with this disease called chronic obstructive pulmonary disease, or COPD for short, is that by the time patients visit their doctor with symptoms, the damage has already been done. At the moment, there is no way to predict which smokers will go on to develop COPD. The aim of this research is to look at smokers who breathe normally and use an imaging technique called a CT scan, to look at their lungs in more detail. Some of these people will have spots on their scan which may be caused by inflammation. We want to look at the cells at these spots to see if they make more proteins and enzymes that cause lung damage when compared to people that do not have these spots. We would then be able to predict which smokers are likely to develop COPD and treat them early before they have damaged their lungs.
Detailed description
Chronic obstructive pulmonary disease, or COPD for short, will be 3rd biggest killer in the world by 2020. The major cause of this disease is cigarette smoking, but only about 15-20% of smokers will develop COPD. In this disease, the lung becomes damaged and patients can not breathe properly. This damage can not be repaired therefore at the moment there are no good treatements for COPD. By the time a patient visits their doctor with symptoms the damage is already done. Therefore in this study we want to look at the lungs of smokers that feel well and can breathe normally. We believe that much of the damage to the lung in COPD is caused by inflammation. In particular, there are more inflammatory cells called macrophages in the lungs of these patients. These macrophages normally protect the lung when we inhale particles like dust and are also inportant to fight infections. In COPD, these macrophages are out of control and produce huge amounts of enzymes that break down lung tissue and more proteins that cause inflammation. We want to see if we can find these macrophages in the lungs of smokers before they get COPD. Recently, a 5 and a half year study showed that some smokers that can breathe normally have increased inflammation in their lungs. This can be seen using a scan called a CT scan. On the CT scan, these areas look like spots. When these smokers had another scan 5 and half years later, in some cases these spots had become holes in their lung. This is called emphysema and is one of the characteristics of COPD. We want to know whether the macrophages in these smokers cause this damage. If this is the case, we have two separate findings from this study. Firstly, we could look at macrophages and predict which smokers will develop COPD and secondly, try and develop new treatments to stop the macrophages from producing all proteins that cause inflammation.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
Who may qualify
- Ages
- 21 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Age 21-70 years. Smoking history of at least 10 pack years. (1 pack year = 20 cigarettes per day for 1 year).
- No history of respiratory or allergic disease. Normal baseline spirometry as predicted for age, sex and height. No history of upper respiratory tract infection in the preceding six weeks. Not taking regular medication -
Key exclusion criteria (3 listed)
- Subjects will not included in this study if they meet any of the following exclusion criteria:
- Clinically significant findings in the medical history or on physical examination.
- Pregnant women or mothers who are breastfeeding. Subjects who are unable to give informed consent -
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
Not reported in the source record.
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 May 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.
Athol Wells, MD principal investigator
Royal Brompton & Harefield NHS Foundation Trust
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 and Emphysema, run by Imperial College London at 1 site in United Kingdom.
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 3 inclusion and 3 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: withdrawn, as of the sponsor's last update on 28 May 2015. 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 United Kingdom. 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?
The study was withdrawn before enrolling participants, so there are no results.
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.
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 28 May 2015.