Changes in Inflammatory Markers During Pulmonary Rehabilitation Based on Exacerbation States in COPD
NCT ID: NCT02740686
Last Updated: 2018-10-19
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
85 participants
OBSERVATIONAL
2016-07-31
2018-08-28
Brief Summary
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Detailed Description
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Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Healthy smokers
Recruited in accordance with inclusion/exclusion criteria with no medical history of COPD diagnosis and currently smoke.This group will be recruited by a nurse using medical records to assess smoking status and age-matching to the COPD groups. A resting blood sample will be taken from these patients and used to compare baseline measurements with the COPD groups.
Sample collection
Frequent exacerbators and infrequent exacerbators will have blood and sputum samples obtained around pulmonary rehabilitation. No other intervention will be administered. Healthy controls will have resting blood samples taken.
Healthy never smokers
Recruited in accordance with inclusion/exclusion criteria with no medical history of COPD diagnosis and have never smoked.This group will be recruited by a nurse using medical records to assess smoking status and age-matching to the COPD groups. Resting blood samples will be taken from these patients and used to compare baseline measurements with the COPD groups.
Sample collection
Frequent exacerbators and infrequent exacerbators will have blood and sputum samples obtained around pulmonary rehabilitation. No other intervention will be administered. Healthy controls will have resting blood samples taken.
Frequent exacerbators
Exacerbations will be defined as "a respiratory event which led to a hospitalisation or the prescription of antibiotics and/or oral corticosteroids". Clinicians will ask patients to retrospectively recall how many exacerbations they have had in the past 12 months. Patients will be allocated to the frequent exacerbators group based on whether they have had 2 or more hospitalisations for exacerbations or have taken 2 or more courses on steroids/antibiotics within the past 12 months. Blood sample collection at the following pulmonary rehabilitation sessions: 1st (pre-exercise), 2nd (pre and post-exercise), 8th (pre-exercise), last session (pre and post exercise). Sputum samples collected pre-exercise at the following pulmonary rehabilitation sessions: 1st, 8th, and last session.
Sample collection
Frequent exacerbators and infrequent exacerbators will have blood and sputum samples obtained around pulmonary rehabilitation. No other intervention will be administered. Healthy controls will have resting blood samples taken.
Infrequent exacerbators
Exacerbations will be defined as "a respiratory event which led to a hospitalisation or the prescription of antibiotics and/or oral corticosteroids". Clinicians will ask patients to retrospectively recall how many exacerbations they have had in the past 12 months. Patients will be allocated to the infrequent exacerbators group based on whether they have had no more than 1 hospitalisation for exacerbations or have not taken more than 1 course of steroids/antibiotics within the past 12 months. Blood sample collection at the following pulmonary rehabilitation sessions: 1st (pre-exercise), 2nd (pre and post-exercise), 8th (pre-exercise), last session (pre and post exercise). Sputum samples collected pre-exercise at the following pulmonary rehabilitation sessions: 1st, 8th, and last session.
Sample collection
Frequent exacerbators and infrequent exacerbators will have blood and sputum samples obtained around pulmonary rehabilitation. No other intervention will be administered. Healthy controls will have resting blood samples taken.
Interventions
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Sample collection
Frequent exacerbators and infrequent exacerbators will have blood and sputum samples obtained around pulmonary rehabilitation. No other intervention will be administered. Healthy controls will have resting blood samples taken.
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* 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.
40 Years
90 Years
ALL
Yes
Sponsors
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National Health Service, United Kingdom
OTHER_GOV
University of Lincoln
OTHER
Responsible Party
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Alex Jenkins
Mr Alex Jenkins
Principal Investigators
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Alex R Jenkins, MPhil
Role: PRINCIPAL_INVESTIGATOR
PhD student
Locations
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Lindum Medical Practice
Lincoln, Lincolnshire, United Kingdom
Nettleham Medical Practice
Lincoln, Lincolnshire, United Kingdom
Welton Surgery
Lincoln, Lincolnshire, United Kingdom
Birchwood Medical Practice
Lincoln, Lincolnshire, United Kingdom
Sudbrooke Drive Community Centre
Lincoln, , United Kingdom
Bracebridge Community Centre
Lincoln, , United Kingdom
Countries
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Other Identifiers
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16/LO/0865
Identifier Type: -
Identifier Source: org_study_id
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