Changes in Inflammatory Markers During Pulmonary Rehabilitation Based on Exacerbation States in COPD

Chronic Obstructive Pulmonary Disease Clinical Trial

— CIMPRES-COPD  

Official title:

Changes in Inflammatory Markers During Pulmonary Rehabilitation Based on Exacerbation States in COPD

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02740686
• Other study ID #: 16/LO/0865
• Status: Completed
• Start date: July 2016
• Est. completion date: August 28, 2018

Study information

• Verified date: October 2018
• Source: University of Lincoln
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

Description:

Pulmonary rehabilitation has been proven to benefit COPD patients in terms of quality of life and functional capabilities. The effects of pulmonary rehabilitation (exercise) on immune function are unclear despite clear benefits of exercise on immune function in healthy individuals being identified. Moderate-intensity and frequency of exercise has been shown to decrease the risk of upper respiratory tract infections in healthy individuals in comparison to sedentary individuals. Respiratory infections, also known as exacerbations, in COPD are the main cause of hospitalisation and mortality. Therefore, if exercise can modulate immune function in COPD, it can be encouraged further in COPD to reduce hospitalisation risk. However, it is important to compare the effects of exercise amongst different phenotypes as frequent exacerbators are known to have elevated inflammatory markers, and may consequently respond to exercise differently to infrequent exacerbators, paving a rationale for a different approach to this subset of patients.

Recruitment information / eligibility

• 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.

Related Conditions & MeSH terms

• Chronic Obstructive Pulmonary Disease
• Lung Diseases
• Lung Diseases, Obstructive
• Pulmonary Disease, Chronic Obstructive

Intervention

Other:
• 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.

Locations

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

Sponsors (2)

Lead Sponsor	Collaborator
University of Lincoln	National Health Service, United Kingdom

Country where clinical trial is conducted

United Kingdom, 

Outcome

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

External Links

•   Update on research progress