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Completed

NCT Number: NCT02740686

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

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.

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Key information

Age range

40 year–90 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Birchwood Medical Practice, Lincoln, Lincolnshire, United Kingdom

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About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Sample collection

Other

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.

Primary outcomes

  1. Concentration of inflammatory markers in plasma and sputum (C-reactive protein, Fibrinogen, Interleukin(IL)-6, IL-8

    Time frame: July 2016 - August 2018

Secondary outcomes

  1. Changes in the expression of anti-inflammatory genes

    Time frame: July 2016 - August 2018

  2. Total and differential blood leukocyte count

    Time frame: July 2016 - August 2018

  3. Pre-activation and activation of blood neutrophils using flow cytometry

    Time frame: July 2016 - August 2018

  4. Pro-coagulant and pro-inflammatory microparticle signatures in plasma

    Time frame: July 2016 - August 2018

  5. Severe, moderate and mild exacerbations (number of /days to defined events, severity, recovery)

    Time frame: July 2016 - August 2018

  6. Respiratory Symptoms™ (RS-Total score; RS-Breathlessness; RS-Cough and Sputum, and RS-Chest Symptoms)

    Time frame: July 2016 - August 2018

  7. Routine clinical outcome measures following pulmonary rehabilitation (completion rates and clinically important differences - ISWT, ESWT, 6MWD, CRQ)

    Time frame: July 2016 - August 2018

  8. Differences in basal levels of inflammation between frequent and infrequent exacerbators in comparison to healthy controls

    Time frame: July 2016 - August 2018

Sponsors and collaborators

Lead sponsor

University of Lincoln

Other

Collaborators

  • National Health Service, United Kingdom

Registry information

Acronym: CIMPRES-COPD

Important dates

Study start
2016
Primary completion
2018
Study completion
2018
First posted
Apr 15, 2016
Registry last updated
Oct 19, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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