The MRC/ABPI COPD Cohort v1.7 (COPDMAP)

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ClinicalTrials.gov Identifier: NCT01620645

Recruitment Status : Unknown

Verified June 2012 by University College, London.
Recruitment status was: Recruiting

First Posted : June 15, 2012

Last Update Posted : June 15, 2012

Sponsor:

Collaborators:

Royal Free Hampstead NHS Trust

Royal Brompton & Harefield NHS Foundation Trust

Imperial College London

Sheffield Teaching Hospitals NHS Foundation Trust

University of Sheffield

University Hospitals, Leicester

University of Leicester

University Hospital Birmingham NHS Foundation Trust

University of Birmingham

Cambridge University Hospitals NHS Foundation Trust

University of Cambridge

Aintree University Hospitals NHS Foundation Trust

University of Liverpool

NHS Lothian

University of Edinburgh

Newcastle University

University of Nottingham

University of Southampton

Information provided by (Responsible Party):

University College, London

Study Description

Brief Summary:

The UK Medical Research Council (MRC) together with the Association of British Pharmaceutical Industries (ABPI) have recently funded a program designed to foster collaboration between academic COPD researchers and the pharmaceutical industry in the UK, with the aim of developing and furthering our research capacity and expertise for the benefit of patients living with this prevalent and disabling condition. This builds on the strong international track record of COPD research in the UK. The program is divided into four work packages (WP1-4), each with specific aims. WP1 will collate and establish data from patient cohorts and share this information through the development of knowledge management platforms. WP2 will specifically assess how airway micro-organisms impact on COPD and how the effects of bacteria and viruses may be modified. WP3 is concerned with tissue injury and repair which are fundamental processes in the development of COPD. WP4 will examine in detail the potential for improving patient outcomes by targeting the skeletal muscle dysfunction that can profoundly affect exercise capacity.

Condition or disease	Intervention/treatment
COPD	Radiation: CT scan and PA chest X-ray

Show Detailed Description

Study Design


Study Type :	Observational
Estimated Enrollment :	400 participants
Observational Model:	Cohort
Time Perspective:	Prospective
Official Title:	The Mechanisms of Inflammation and Immunity in COPD and Their Relationship to Exacerbations and Disease Progression.
Study Start Date :	February 2011

Resource links provided by the National Library of Medicine

Drug Information available for: X-Rays

U.S. FDA Resources

Groups and Cohorts

Group/Cohort	Intervention/treatment
COPD, GOLD II severity or above	Radiation: CT scan and PA chest X-ray All participants will receive a single high resolution CT scan of the chest. This will be performed using a low tube current, helical technique. Participants may also receive a plain chest X-ray if clinically indicated. The total research protocol dose is 2 mSv. The dose from the chest X-ray is insignificant compared with the dose from the CT scan of the chest, therefore all this dose can be considered to be additional to standard of care. A dose of 2 mSv represents a risk of radiation induced detriment of approximately 1 in 10,000 and is equivalent to about 11 months of average natural background radiation in the UK.

Group/Cohort

Intervention/treatment

COPD, GOLD II severity or above

Radiation: CT scan and PA chest X-ray

All participants will receive a single high resolution CT scan of the chest. This will be performed using a low tube current, helical technique. Participants may also receive a plain chest X-ray if clinically indicated.

The total research protocol dose is 2 mSv. The dose from the chest X-ray is insignificant compared with the dose from the CT scan of the chest, therefore all this dose can be considered to be additional to standard of care. A dose of 2 mSv represents a risk of radiation induced detriment of approximately 1 in 10,000 and is equivalent to about 11 months of average natural background radiation in the UK.

Outcome Measures

Biospecimen Retention: Samples With DNA

Blood, sputum and urine samples will be collected. Commercially available ELISA assays will be be used to qualify inflammatory markers.

Quantitative bacterial culture will be performed on sputum samples. Bacterial and viral load will be determined by polymerase chain reaction (PCR). Proteomics such as Cholesterol, BNP, CRP by routine hospital assay techniques. Specific DNA sections will be selected from the genome to identify/confirm genes believed to be associated with different COPD phenotypes by molecular techniques.

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:	40 Years and older (Adult, Older Adult)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No
Sampling Method:	Non-Probability Sample

Study Population

Patients will be recruited from existing cohorts and may have participated in previously approved studies.

Potential primary care patients will be identified from databases held in practices and contacted, by the GP, by letter in the first instance. If the patient replies to the GP that they are willing to participate in the research, then a telephone call will be made by the research team to arrange a clinic visit.

Potential outpatient participants will be identified by the outpatient respiratory physician and if willing to participate will be referred to the research team via telephone call or referral letter.

Criteria

Inclusion Criteria:

Confirmed spirometric evidence of moderate to very severe COPD (stage II to IV) according to the WHO GOLD criteria:
All patients FEV1/FVC <70%
Stage II FEV1 50-80% predicted
Stage III FEV1 30-50% predicted
Stage IV FEV1 <30% predicetd or <50% predicted and chronic respiratory symptoms
Past or present smokers
Gender: male or female
Age >40 years at recruitment
Reasonable command of English to complete daily diary cards

Exclusion Criteria:

History of asthma
History of neoplasia
History of other significant respiratory disease
Pregnancy

Contacts and Locations