NCT00298402

Brief 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. 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.

Trial Health

30
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Timeline
Completed

Started Oct 2005

Geographic Reach
1 country

1 active site

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2005

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

March 1, 2006

Completed
1 day until next milestone

First Posted

Study publicly available on registry

March 2, 2006

Completed
1.6 years until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2007

Completed
Last Updated

May 28, 2015

Status Verified

March 1, 2006

First QC Date

March 1, 2006

Last Update Submit

May 27, 2015

Conditions

Keywords

macrophageMMPCT scan

Eligibility Criteria

Age21 Years - 70 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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 -

You may not qualify if:

  • 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 -

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Imperial College London

London, SW3 6LY, United Kingdom

Location

MeSH Terms

Conditions

Pulmonary Disease, Chronic ObstructiveEmphysemaBronchitis, Chronic

Condition Hierarchy (Ancestors)

Lung Diseases, ObstructiveLung DiseasesRespiratory Tract DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and SymptomsBronchitisRespiratory Tract InfectionsInfectionsBronchial Diseases

Study Officials

  • Athol Wells, MD

    Royal Brompton & Harefield NHS Foundation Trust

    PRINCIPAL INVESTIGATOR
0

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER

Study Record Dates

First Submitted

March 1, 2006

First Posted

March 2, 2006

Study Start

October 1, 2005

Study Completion

October 1, 2007

Last Updated

May 28, 2015

Record last verified: 2006-03

Locations