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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
Information provided by (Responsible Party):

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
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.

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, Senior)
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.


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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01620645

United Kingdom
Royal Free Hampstead NHS Trust Recruiting
London, United Kingdom, NW3 2QG
Contact: Richa Singh, MA MBBS MRCP    +442077940500 ext 34308    r.singh@ucl.ac.uk   
Contact: Gavin Donaldson, BSc PhD    +442077940500 ext 34308    g.donaldson@ucl.ac.uk   
Principal Investigator: Wisia Wedzicha, BSc MBBS MD         
Sponsors and Collaborators
University College, London
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
More Information

Responsible Party: University College, London
ClinicalTrials.gov Identifier: NCT01620645     History of Changes
Other Study ID Numbers: CSP-83727
First Posted: June 15, 2012    Key Record Dates
Last Update Posted: June 15, 2012
Last Verified: June 2012