Skip to main content
OpenTrials
Completed

NCT Number: NCT02644772

Preventing Repeat Hospitalisations in Patients With Chronic Obstructive Pulmonary Disease (COPD)

The purpose of this study is to determine whether the investigators can predict which patients are at risk of a re-exacerbation of COPD within 30 and 90 days using changes in lung capacity during the initial exacerbation.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Chronic Obstructive Pulmonary Disease (COPD) Chronic Disease Disease Attributes Lung Diseases Lung Diseases, Obstructive Pathologic Processes Pathological Conditions, Signs and Symptoms Pulmonary Disease, Chronic Obstructive Respiratory Tract Diseases

Age range

35 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Beaumont Hospital

Dublin, Ireland

About this study

Patients admitted to hospital with an acute exacerbation of COPD will be approached to participate in the study.

The investigators will analyse changes in lung capacity (through measurement of spirometry and inspiratory capacity) and physical activity level over the first three days of admission, at discharge and at a day 30 follow-up visit. The investigators will record quality of life and symptom scores at these time points and again at a day 90 telephone visit. Data relating to the patients overall health status -disease severity, co-morbidity, cognition, psychological status, home environment and adherence to inhaled medication will be collected. The investigators will look for any relationship between these changes and a further exacerbations within 30 and 90 days.

The central hypothesis of this proposal is that the clinical course following an exacerbation of COPD may be monitored through measurement of inspiratory capacity(IC), a marker of lung hyperinflation. Resolution of an exacerbation is related to an increase in inspiratory capacity above a threshold level of improvement, after which the risk of re-exacerbation within the subsequent 30 and 90 days is low. The investigators will assess the accuracy of IC as a predictor of exacerbation and the feasibility of measuring IC during the early stages of a COPD exacerbation.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Within 72 hours of admission with an Acute Exacerbation of COPD (AE COPD) defined as "an acute change in a patient's baseline dyspnoea, cough and/or sputum beyond day-to-day variability sufficient to warrant a change in therapy" as per ATS/ERS consensus guidelines[ ] where "a change in therapy" includes the following: Prescription of antibiotics and / or systemic steroids
  • Diagnosis of COPD based on GOLD criteria
  • Able to give informed consent
  • Willing to participate in the study

Exclusion criteria

  • Admission reason other than AE COPD or breathlessness primarily caused by another pathology
  • Already enrolled in the study
  • Receiving palliative care
  • Severe cognitive impairment or psychological disorder that results in inability to give informed consent or complete investigations required for the study
  • Physical impairment resulting in inability to complete physiological tests

Treatment and study plan

Primary outcomes

  1. The relationship between change in inspiratory capacity(IC), from admission with an exacerbation of COPD to hospital discharge, and the risk of 30-day and 90-day re-exacerbation is reduced.

    Time frame: From admission to 90 days from hospitalisation with an exacerbation

Secondary outcomes

  1. Relationship between changes in IC and respiratory symptoms

    Time frame: From admission to 30 days from hospitalisation with an exacerbation

    Medical Research Council(MRC) and Borg breathlessness scores and IC will be measured at hospitalisation with an exacerbation of COPD and at 30 days post exacerbation and correlated.

  2. Relationship between changes in Forced Expiratory Volume in 1 second (FEV1) and respiratory symptoms

    Time frame: From admission to 30 days from hospitalisation with an exacerbation

    Medical Research Council(MRC) and Borg breathlessness scores and FEV1 will be measured at hospitalisation with an exacerbation of COPD and at 30 days post exacerbation and correlated.

  3. Relationship between changes in Forced Vital Capacity and respiratory symptoms

    Time frame: From admission to 30 days from hospitalisation with an exacerbation

    Medical Research Council(MRC) and Borg breathlessness scores and FVC will be measured at hospitalisation with an exacerbation of COPD and at 30 days post exacerbation and correlated.

  4. Relationship between change in IC and quality of life scores

    Time frame: From admission to 30 days from hospitalisation with an exacerbation

    COPD Assessment Test (CAT) quality of life score and IC will be measured at hospitalisation with an exacerbation of COPD and at 30 days post exacerbation and correlated.

  5. Relationship between change in FEV1 and quality of life scores

    Time frame: From admission to 30 days from hospitalisation with an exacerbation

    COPD Assessment Test (CAT) quality of life score and FEV1 will be measured at hospitalisation with an exacerbation of COPD and at 30 days post exacerbation and correlated.

  6. Relationship between change in FVC and quality of life scores

    Time frame: From admission to 30 days from hospitalisation with an exacerbation

    COPD Assessment Test (CAT) quality of life score and FVC will be measured at hospitalisation with an exacerbation of COPD and at 30 days post exacerbation and correlated.

  7. Relationship between change in IC and gait speed

    Time frame: From admission to 30 days from hospitalisation with an exacerbation

    4 metre gait speed test and IC will be measured at hospitalisation with an exacerbation of COPD and at 30 days post exacerbation and correlated.

  8. Relationship between change in FEV1 and gait speed

    Time frame: From admission to 30 days from hospitalisation with an exacerbation

    4 metre gait speed test and FEV1 will be measured will be measured at hospitalisation with an exacerbation of COPD and at 30 days post exacerbation and correlated.

  9. Relationship between change in FVC and gait speed

    Time frame: From admission to 30 days from hospitalisation with an exacerbation

    4 metre gait speed test and FVC will be measured at hospitalisation with an exacerbation of COPD and at 30 days post exacerbation and correlated.

  10. Relationship between patient factors and subsequent exacerbation

    Time frame: 90 days from hospitalisation with an exacerbation

    The association between patient factors (to include baseline GOLD grade, Charlston co-morbidity index score, Katz index, Hospital Anxiety and Depression Scale (HADS) score, Montreal Cognitive Assessment (MOCA) score) and exacerbation in the entire cohort and in those who do and do not achieve a rise in IC compared to baseline values will be examined

  11. Time to re-exacerbation

    Time frame: 90 days from hospitalisation with an exacerbation

  12. Sensitivity of vital capacity measures taken with a bedside portable spirometer compared with those performed in the pulmonary function test laboratory

    Time frame: Day 3-7 of hospital admission

    Vital capacity will be measured at the bedside with a portable spirometer and using gold standard spirometry in a pulmonary function laboratory. These two measurements will then be compared and correlated.

  13. Sensitivity of FEV1 measures taken with a bedside portable spirometer compared with those performed in the pulmonary function test laboratory

    Time frame: Day 3-7 of hospital admission

    FEV1 will be measured at the bedside with a portable spirometer and using gold standard spirometry in a pulmonary function laboratory. These two measurements will then be compared and correlated.

  14. Sensitivity of inspiratory capacity (IC) measured with a bedside portable spirometer and by the gold standard body plethysmography

    Time frame: Day 3-7 of hospital admission

    IC will be measured at the bedside with a portable spirometer and by gold standard body plethysmography in a pulmonary function laboratory. These two measurements will then be compared and correlated.

  15. Change in vital capacity during an exacerbation and its relationship to re-exacerbation

    Time frame: At days 1-3 of admission, hospital discharge and 30 days from hospitalisation with an exacerbation

  16. Change in FEV1 during an exacerbation and its relationship to re-exacerbation

    Time frame: At days 1-3 of admission, hospital discharge and 30 days from hospitalisation with an exacerbation

  17. Relationship between Exacerbation factors and re-exacerbation

    Time frame: 90 days from hospitalisation with an exacerbation

    The association between exacerbation severity as determined by DECAF score, need for non-invasive ventilation or critical care, length of hospital stay in the entire cohort and in those who do and do not achieve a rise in IC compared to baseline values will be examined

  18. Relationship between Social and Environmental factors and subsequent exacerbation

    Time frame: 90 days from hospitalisation with an exacerbation

    The impact of patients social environment as determined by living conditions, presence of home supports, socioeconomic group in the entire cohort and in those who do and do not achieve a rise in IC compared to baseline values will be examined

Sponsors and collaborators

Lead sponsor

Beaumont Hospital

Other

Collaborators

  • Royal College of Surgeons, Ireland

Registry information

Official study title

Risk Factors for Re-exacerbation After a Chronic Obstructive Pulmonary Disease (COPD) Exacerbation

Acronym: INCA R-ACE

Important dates

Study start
2015
Primary completion
2017
Study completion
2018
First posted
Jan 1, 2016
Registry last updated
Jul 18, 2019

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.

Related clinical trials

Published trials that share one or more normalized conditions with this study.