Markers for emphysema versus airways disease in chronic obstructive pulmonary disease (COPD)
| ISRCTN | ISRCTN44642272 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN44642272 |
| Protocol serial number | 5323 |
| Sponsor | University Hospitals of Leicester NHS Trust (UK) |
| Funder | European Commission (Belgium) |
- 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
| Primary study design | Observational |
|---|---|
| Study design | Multicentre non-randomised observational prevention and cohort study |
| Secondary study design | Cohort study |
| 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(s) |
To use CT scanning to identify patients with COPD with predominant airway wall changes |
| Key secondary outcome measure(s) |
1. Development of new diagnostic tools and to new therapies for COPD |
| Completion date | 31/03/2011 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Child |
| Sex | |
| Target sample size at registration | 1000 |
| 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
- United Kingdom
- England
Study participating centre
Medicines Evaluation Unit Ltd
Manchester
M23 9QZ
United Kingdom
M23 9QZ
United Kingdom
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 01/07/2016 | Yes | No | |
| Protocol article | protocol | 01/10/2012 | Yes | No |
Editorial Notes
27/09/2018: Publication reference added.
