Markers for emphysema versus airways disease in chronic obstructive pulmonary disease (COPD)

ISRCTN	ISRCTN44642272
DOI	https://doi.org/10.1186/ISRCTN44642272
Secondary identifying numbers	5323

Submission date: 21/05/2010
Registration date: 21/05/2010
Last edited: 27/09/2018

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Respiratory

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

Contact information

Dr Dave Singh
Scientific

Medicines Evaluation Unit Ltd
The Langley Building
Southmoor Road
Wythenshawe
Manchester
M23 9QZ
United Kingdom

Email	dsingh@meu.org.uk

Study information

Study design	Multicentre non-randomised observational prevention and cohort study
Primary study design	Observational
Secondary study design	Cohort study
Study setting(s)	Hospital
Study type	Prevention
Scientific title	Markers for emphysema versus airways disease in chronic obstructive pulmonary disease (COPD)
Study acronym	Markers for Emphysema versus Airways disease in COPD
Study objectives	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(s)	MREC approved (ref: 08/H0402/19)
Health condition(s) or problem(s) studied	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
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 study start date	01/04/2008
Completion date	31/03/2011

Eligibility

Participant type(s)	Patient
Age group	Child
Sex
Target number of participants	Planned sample size: 1000; UK sample size: 600
Key inclusion criteria	Not provided at time of registration
Key exclusion criteria	Not provided at time of registration
Date of first enrolment	01/04/2008
Date of final enrolment	31/03/2011

Locations

Countries of recruitment

England
United Kingdom

Study participating centre

Medicines Evaluation Unit Ltd

Manchester
M23 9QZ
United Kingdom

Sponsor information

University Hospitals of Leicester NHS Trust (UK)
Hospital/treatment centre

Leicester Royal Infirmary
Infirmary Square
Leicester
LE1 5WW
England
United Kingdom

Website	http://www.uhl-tr.nhs.uk/
"ROR"	https://ror.org/02fha3693

Funders

Funder type

Government

European Commission (Belgium)
Government organisation / National government

Alternative name(s): European Union, Comisión Europea, Europäische Kommission, EU-Kommissionen, Euroopa Komisjoni, EC, EU

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to share	No
IPD sharing plan summary
Publication and dissemination plan	Not provided at time of registration
IPD sharing plan

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Protocol article	protocol	01/10/2012		Yes	No
Results article	results	01/07/2016		Yes	No

Editorial Notes

27/09/2018: Publication reference added.