Chronic Obstructive Pulmonary Disease Clinical Trial
— CIMPRES-COPDOfficial title:
Changes in Inflammatory Markers During Pulmonary Rehabilitation Based on Exacerbation States in COPD
NCT number | NCT02740686 |
Other study ID # | 16/LO/0865 |
Secondary ID | |
Status | Completed |
Phase | |
First received | |
Last updated | |
Start date | July 2016 |
Est. completion date | August 28, 2018 |
Verified date | October 2018 |
Source | University of Lincoln |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
This study will examine the inflammatory response to exercise encompassed as part of a standard pulmonary rehabilitation programme in patients with chronic obstructive pulmonary disease (COPD). Patients will be split into two groups, frequent exacerbators or infrequent exacerbators, dependent upon exacerbation history to compare responses to pulmonary rehabilitation amongst phenotypes.
Status | Completed |
Enrollment | 85 |
Est. completion date | August 28, 2018 |
Est. primary completion date | August 28, 2018 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 40 Years to 90 Years |
Eligibility |
Inclusion Criteria: - 58 frequent exacerbators and 58 infrequent exacerbators (116 in total) who have been diagnosed with any severity of COPD (according to BTS criteria, i.e. >10 pack year smoking history and post bronchodilator spirometry FEV1/FVC ratio <0.70 and FEV<80%). Exclusion Criteria: - Inability or unwillingness to sign informed consent - Any unstable ongoing cardiovascular events which may be exacerbated by exercise - Inability to complete walk tests due to physical or mental impairment - Other active inflammatory conditions e.g. rheumatoid arthritis, cancer. - Known asthma, allergic rhinitis or other respiratory disease (bronchiectasis, pulmonary fibrosis) Healthy control group - Patients who have not been diagnosed with COPD or any other respiratory condition and are characteristically (age (between 45-85 years old) & smoking status) matched to recruited COPD patients. |
Country | Name | City | State |
---|---|---|---|
United Kingdom | Birchwood Medical Practice | Lincoln | Lincolnshire |
United Kingdom | Bracebridge Community Centre | Lincoln | |
United Kingdom | Lindum Medical Practice | Lincoln | Lincolnshire |
United Kingdom | Nettleham Medical Practice | Lincoln | Lincolnshire |
United Kingdom | Sudbrooke Drive Community Centre | Lincoln | |
United Kingdom | Welton Surgery | Lincoln | Lincolnshire |
Lead Sponsor | Collaborator |
---|---|
University of Lincoln | National Health Service, United Kingdom |
United Kingdom,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Concentration of inflammatory markers in plasma and sputum (C-reactive protein, Fibrinogen, Interleukin(IL)-6, IL-8 | July 2016 - August 2018 | ||
Secondary | Changes in the expression of anti-inflammatory genes | July 2016 - August 2018 | ||
Secondary | Total and differential blood leukocyte count | July 2016 - August 2018 | ||
Secondary | Pre-activation and activation of blood neutrophils using flow cytometry | July 2016 - August 2018 | ||
Secondary | Pro-coagulant and pro-inflammatory microparticle signatures in plasma | July 2016 - August 2018 | ||
Secondary | Severe, moderate and mild exacerbations (number of /days to defined events, severity, recovery) | July 2016 - August 2018 | ||
Secondary | Respiratory Symptoms™ (RS-Total score; RS-Breathlessness; RS-Cough and Sputum, and RS-Chest Symptoms) | July 2016 - August 2018 | ||
Secondary | Routine clinical outcome measures following pulmonary rehabilitation (completion rates and clinically important differences - ISWT, ESWT, 6MWD, CRQ) | July 2016 - August 2018 | ||
Secondary | Differences in basal levels of inflammation between frequent and infrequent exacerbators in comparison to healthy controls | July 2016 - August 2018 |
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