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
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dsingh@meu.org.uk
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
5323
Study information
Scientific title
Markers for emphysema versus airways disease in chronic obstructive pulmonary disease (COPD)
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 measure
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 (if study stopped)
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
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
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
Basic results (scientific)
Publication list
1. 2012 protocol in http://www.ncbi.nlm.nih.gov/pubmed/22441733
2. 2016 results in https://www.ncbi.nlm.nih.gov/pubmed/27230444
Publication citations
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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.