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| ID | Type | Description | Link |
|---|---|---|---|
| RESP RES-001 (117027) | Other Grant/Funding Number | GSK Abbreviated title and eTrack study number |
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| Name | Class |
|---|---|
| GlaxoSmithKline | INDUSTRY |
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Chronic obstructive pulmonary disease (COPD) is the fourth most common cause of death and the only one of the common causes that is still rising. The main effects of the disease are the destruction and inflammation of lung tissue rendering breathing difficult. COPD has significant effects on the quality of life of sufferers and the disease is predicted to be the fifth most common cause of disability in the world by 2020. Patients with COPD are prone to periods of worsening disease symptoms, known as exacerbations, which are often caused by viral and bacterial infections of the lung and current vaccines appear to have little efficacy in limiting these exacerbations. The loss of lung function caused by infectious exacerbations is irreversible and patients who frequently exacerbate experience more rapid disease progression. Nontypeable Haemophilus influenzae (NTHi) is a major bacterial species that colonises the airways and causes exacerbations in COPD. With the development of more sensitive molecular techniques it has been possible to ascertain that it is the acquisition of new strains of NTHi that correlate strongly with exacerbations. However, not all patients with COPD have NTHi in their lungs and the question remains as to why some COPD patients are susceptible to such infections. This study aims to answer this question by comparing the airways of COPD patients who are colonized by NTHi and those who are not to analyse whether the levels of protective antibodies in the lungs and the function of the immune cells in the NTHi colonized airway are reduced. Moreover, we aim to correlate this reduction in immunity with areas of lung damage ascertained by high resolution computed tomography. The aim of this research is to better understand this apparent deficiency in airway immunity as this is likely to impact on vaccine efficacy in COPD.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| NTHi positive | No intervention, this is an observational study | ||
| NTHi negative | No intervention, this is an observational study | ||
| Healthy Control | No intervention, this is an observational study |
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| Measure | Description | Time Frame |
|---|---|---|
| Detection of NTHi in radiologically-designated areas of disease in the COPD lung | The overall aim of this project is to enhance our understanding of the relevance of local immunity to protection of the airway from viral and bacterial infection and thus development of vaccines against such organisms. | Within 2 years of enrollment |
| Measurement of NTHi specific antibody levels in lavage derived from radiologically-designated areas of disease in the COPD lung | The overall aim of this project is to enhance our understanding of the relevance of local immunity to protection of the airway from viral and bacterial infection and thus development of vaccines against such organisms. | Within 2 years of enrollment |
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Inclusion Criteria:
Exclusion Criteria:
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Volunteers will be recruited from General Practice in the form of patient screening clinics,and GP Mailshot. Quitters and pulmonary rehabilitation, would also be approached. The Respiratory Centre, patient support groups, and outpatient departments and wards, would also be areas of recruitment.
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| Name | Affiliation | Role |
|---|---|---|
| Tom MA Wilkinson, MA MB BS MRCP PhD | University of Southampton | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Southampton University Hospital NHS Trust | Southampton | Hampshire | SO16 6YD | United Kingdom |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 26645414 | Result | Ostridge K, Williams N, Kim V, Bennett M, Harden S, Welch L, Bourne S, Coombs NA, Elkington PT, Staples KJ, Wilkinson TM. Relationship between pulmonary matrix metalloproteinases and quantitative CT markers of small airways disease and emphysema in COPD. Thorax. 2016 Feb;71(2):126-32. doi: 10.1136/thoraxjnl-2015-207428. Epub 2015 Dec 8. | |
| 27460105 |
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| Type | Date | Date Unknown |
|---|---|---|
| Release | Jun 29, 2017 | |
| Reset | Nov 27, 2017 | |
| Release | May 15, 2018 | |
| Reset | Nov 28, 2018 |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Jun 29, 2017 | Nov 27, 2017 | |||
| May 15, 2018 |
| ID | Term |
|---|---|
| D029424 | Pulmonary Disease, Chronic Obstructive |
| ID | Term |
|---|---|
| D008173 | Lung Diseases, Obstructive |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D002908 | Chronic Disease |
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Serum, plasma, inflammatory cell RNA/DNA, nasopharyngeal swabs, urine, sputum supernatants, sputum cells, bronchial epitehlial cells, BAL supernatants, BAL cells, bronchial biopsies.
| Ostridge K, Williams N, Kim V, Harden S, Bourne S, Coombs NA, Elkington PT, Estepar RS, Washko G, Staples KJ, Wilkinson TM. Distinct emphysema subtypes defined by quantitative CT analysis are associated with specific pulmonary matrix metalloproteinases. Respir Res. 2016 Jul 26;17(1):92. doi: 10.1186/s12931-016-0402-z. |
| Nov 28, 2018 |
| D020969 |
| Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |