Macrophages in Smokers' Lung

This study has been withdrawn prior to enrollment.
Sponsor:
Collaborator:
Royal Brompton & Harefield NHS Foundation Trust
Information provided by:
Imperial College London
ClinicalTrials.gov Identifier:
NCT00298402
First received: March 1, 2006
Last updated: March 19, 2014
Last verified: March 2006
  Purpose

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.


Condition
Chronic Obstructive Pulmonary Disease
Emphysema
Chronic Bronchitis

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Prospective
Official Title: The Role of Macrophages in the Pathophysiology of Smokers' Lung

Resource links provided by NLM:


Further study details as provided by Imperial College London:

Enrollment: 0
Study Start Date: October 2005
Estimated Study Completion Date: October 2007
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.

  Eligibility

Ages Eligible for Study:   21 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

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 -

Exclusion Criteria:

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 -

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00298402

Locations
United Kingdom
Imperial College London
London, United Kingdom, SW3 6LY
Sponsors and Collaborators
Imperial College London
Royal Brompton & Harefield NHS Foundation Trust
Investigators
Principal Investigator: Athol Wells, MD Royal Brompton Hospital
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00298402     History of Changes
Other Study ID Numbers: 05/Q0404/87
Study First Received: March 1, 2006
Last Updated: March 19, 2014
Health Authority: United Kingdom: Research Ethics Committee

Keywords provided by Imperial College London:
macrophage
MMP
CT scan

Additional relevant MeSH terms:
Bronchitis
Bronchitis, Chronic
Emphysema
Pulmonary Emphysema
Lung Diseases
Pulmonary Disease, Chronic Obstructive
Lung Diseases, Obstructive
Bronchial Diseases
Respiratory Tract Diseases
Respiratory Tract Infections
Pathologic Processes

ClinicalTrials.gov processed this record on August 26, 2014