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
Scientific
Medicines Evaluation Unit Ltd
The Langley Building
Southmoor Road
Wythenshawe
Manchester
M23 9QZ
United Kingdom
| 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 | Not Specified |
| 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
M23 9QZ
United Kingdom
Sponsor information
University Hospitals of Leicester NHS Trust (UK)
Hospital/treatment centre
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
Government organisation / National government
- Alternative name(s)
- European Union, Comisión Europea, Europäische Kommission, EU-Kommissionen, Euroopa Komisjoni, Ευρωπαϊκής Επιτροπής, Европейската комисия, Evropské komise, Commission européenne, Choimisiúin Eorpaigh, Europskoj komisiji, Commissione europea, La Commissione europea, Eiropas Komisiju, Europos Komisijos, Európai Bizottságról, Europese Commissie, Komisja Europejska, Comissão Europeia, Comisia Europeană, Európskej komisii, Evropski komisiji, Euroopan komission, Europeiska kommissionen, EC, EU
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| 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.
