Condition category
Respiratory
Date applied
21/05/2010
Date assigned
21/05/2010
Last edited
29/07/2013
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr Dave Singh

ORCID ID

Contact details

Medicines Evaluation Unit Ltd
The Langley Building
Southmoor Road
Wythenshawe
Manchester
M23 9QZ
United Kingdom
dsingh@meu.org.uk

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

5323

Study information

Scientific title

Acronym

Markers for Emphysema versus Airways disease in COPD

Study hypothesis

Our hypothesis is that the mechanisms leading to emphysema and airway disease are distinct with respect to the type of inflammatory response in terms of genetic predisposition. The differential pathogenesis for emphysema and inflammatory airway disease entails that the two forms of COPD are linked to different markers at the DNA, RNA and protein level.



The project aims at identifying these markers. The markers will be elements involved in a differential pathogenesis for the different disease processes in COPD. They can be used for diagnostic approaches and therapeutic targets.

Ethics approval

MREC approved (ref: 08/H0402/19)

Study design

Multicentre non-randomised observational prevention and cohort study

Primary study design

Observational

Secondary study design

Cohort study

Trial setting

Hospitals

Trial type

Prevention

Patient information sheet

Condition

Topic: Respiratory; Subtopic: Respiratory (all Subtopics); Disease: Respiratory

Intervention

1. Blood sample
2. Bronchoscopy
3. Computed tomography (CT) Scan
4. Lung samples
5. Sputum collection

Intervention type

Other

Phase

Not Specified

Drug names

Primary outcome measures

To use CT scanning to identify patients with COPD with predominant airway wall changes

Secondary outcome measures

1. Development of new diagnostic tools and to new therapies for COPD
2. Understanding differences in pattern of inflammation and genetic predisposition

Overall trial start date

01/04/2008

Overall trial end date

31/03/2011

Reason abandoned

Eligibility

Participant inclusion criteria

Not provided at time of registration

Participant type

Patient

Age group

Child

Gender

Not Specified

Target number of participants

Planned sample size: 1000; UK sample size: 600

Participant exclusion criteria

Not provided at time of registration

Recruitment start date

01/04/2008

Recruitment end date

31/03/2011

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Medicines Evaluation Unit Ltd
Manchester
M23 9QZ
United Kingdom

Sponsor information

Organisation

University Hospitals of Leicester NHS Trust (UK)

Sponsor details

Leicester Royal Infirmary
Infirmary Square
Leicester
LE1 5WW
United Kingdom

Sponsor type

Hospital/treatment centre

Website

http://www.uhl-tr.nhs.uk/

Funders

Funder type

Government

Funder name

European Commission (Belgium)

Alternative name(s)

EC

Funding Body Type

government organisation

Funding Body Subtype

Federal/National Government

Location

Belgium

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

2012 protocol in http://www.ncbi.nlm.nih.gov/pubmed/22441733

Publication citations

  1. Protocol

    Ziegler-Heitbrock L, Frankenberger M, Heimbeck I, Burggraf D, Wjst M, Häussinger K, Brightling C, Gupta S, Parr D, Subramanian D, Singh D, Kolsum U, Boschetto P, Potena A, Gorecka D, Nowinski A, Barta I, Döme B, Strausz J, Greulich T, Vogelmeier C, Bals R, Hohlfeld JM, Welte T, Venge P, Gut I, Boland A, Olaso R, Hager J, Hiemstra P, Rabe KF, Unmüssig M, Müller-Quernheim J, Prasse A, The EvA study: aims and strategy., Eur. Respir. J., 2012, 40, 4, 823-829, doi: 10.1183/09031936.00142811.

Additional files

Editorial Notes