NCT01620645

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.

Trial Health

55
Monitor

Trial Health Score

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

Enrollment
400

participants targeted

Target at P75+ for all trials

Geographic Reach
1 country

1 active site

Status
unknown

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2011

Completed
1.4 years until next milestone

First Submitted

Initial submission to the registry

June 13, 2012

Completed
2 days until next milestone

First Posted

Study publicly available on registry

June 15, 2012

Completed
Last Updated

June 15, 2012

Status Verified

June 1, 2012

First QC Date

June 13, 2012

Last Update Submit

June 13, 2012

Conditions

COPD

Study Arms (1)

COPD, GOLD II severity or above

Radiation: CT scan and PA chest X-ray

Interventions

CT scan and PA chest X-rayRADIATION

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.

COPD, GOLD II severity or above

Eligibility Criteria

Age40 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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.

You may qualify if:

  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Royal Free Hampstead NHS Trust

London, London, NW3 2QG, United Kingdom

RECRUITING

Related Publications (1)

  • Wang Z, Singh R, Miller BE, Tal-Singer R, Van Horn S, Tomsho L, Mackay A, Allinson JP, Webb AJ, Brookes AJ, George LM, Barker B, Kolsum U, Donnelly LE, Belchamber K, Barnes PJ, Singh D, Brightling CE, Donaldson GC, Wedzicha JA, Brown JR; COPDMAP. Sputum microbiome temporal variability and dysbiosis in chronic obstructive pulmonary disease exacerbations: an analysis of the COPDMAP study. Thorax. 2018 Apr;73(4):331-338. doi: 10.1136/thoraxjnl-2017-210741. Epub 2017 Dec 21.

    PMID: 29269441DERIVED

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.

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Condition Hierarchy (Ancestors)

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

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 13, 2012

First Posted

June 15, 2012

Study Start

February 1, 2011

Last Updated

June 15, 2012

Record last verified: 2012-06

Locations

GB(1)