Chronic Obstructive Pulmonary Disease (COPD)INCA R-ACENCT02644772
Preventing Repeat Hospitalisations in Patients With Chronic Obstructive Pulmonary Disease (COPD)
An observational study of Chronic Obstructive Pulmonary Disease (COPD), run by Beaumont Hospital at 1 site in Ireland.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 35 years and older
- Conditions the study is for
- Chronic Obstructive Pulmonary Disease (COPD)
- How many people
- 207 participants
- Where
- 1 siteIreland
- Study dates
- Oct 2015to Sep 2018
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 35 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients admitted to hospital with an acute exacerbation of COPD
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Risk Factors for Re-exacerbation After a Chronic Obstructive Pulmonary Disease (COPD) Exacerbation
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.
Read the detailed description
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.
- Keywords
- Acute Exacerbation of COPD, Clinical problems in COPD
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: From admission to 90 days from hospitalisation with an exacerbation
Secondary outcomes (18)
Relationship between changes in IC and respiratory symptoms
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.
Measured: From admission to 30 days from hospitalisation with an exacerbation
Relationship between changes in Forced Expiratory Volume in 1 second (FEV1) and respiratory symptoms
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.
Measured: From admission to 30 days from hospitalisation with an exacerbation
Relationship between changes in Forced Vital Capacity and respiratory symptoms
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.
Measured: From admission to 30 days from hospitalisation with an exacerbation
Relationship between change in IC and quality of life scores
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.
Measured: From admission to 30 days from hospitalisation with an exacerbation
Relationship between change in FEV1 and quality of life scores
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.
Measured: From admission to 30 days from hospitalisation with an exacerbation
Relationship between change in FVC and quality of life scores
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.
Measured: From admission to 30 days from hospitalisation with an exacerbation
Relationship between change in IC and gait speed
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.
Measured: From admission to 30 days from hospitalisation with an exacerbation
Relationship between change in FEV1 and gait speed
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.
Measured: From admission to 30 days from hospitalisation with an exacerbation
Relationship between change in FVC and gait speed
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.
Measured: From admission to 30 days from hospitalisation with an exacerbation
Relationship between patient factors and subsequent 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
Measured: 90 days from hospitalisation with an exacerbation
Time to re-exacerbation
Measured: 90 days from hospitalisation with an exacerbation
Sensitivity of vital capacity measures taken with a bedside portable spirometer compared with those performed in the pulmonary function test laboratory
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.
Measured: Day 3-7 of hospital admission
Sensitivity of FEV1 measures taken with a bedside portable spirometer compared with those performed in the pulmonary function test laboratory
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.
Measured: Day 3-7 of hospital admission
Sensitivity of inspiratory capacity (IC) measured with a bedside portable spirometer and by the gold standard body plethysmography
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.
Measured: Day 3-7 of hospital admission
Change in vital capacity during an exacerbation and its relationship to re-exacerbation
Measured: At days 1-3 of admission, hospital discharge and 30 days from hospitalisation with an exacerbation
Change in FEV1 during an exacerbation and its relationship to re-exacerbation
Measured: At days 1-3 of admission, hospital discharge and 30 days from hospitalisation with an exacerbation
Relationship between Exacerbation factors and re-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
Measured: 90 days from hospitalisation with an exacerbation
Relationship between Social and Environmental factors and subsequent 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
Measured: 90 days from hospitalisation with an exacerbation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jan 2016 (estimated)
- Study startOct 2015
- Primary completionJul 2017
- Study completionSep 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Obstructive Pulmonary Disease (COPD)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 207 participants (actual)
Sponsor and investigators
- Lead sponsor
- Beaumont Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Royal College of Surgeons, Ireland
- Responsible party
- Principal investigator, Professor Richard Costello, Beaumont Hospital
- Investigators
- Richard W Costello, Principal investigator, Beaumont Hospital, Dublin, Ireland
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02644772
- Sponsor's protocol ID
- INCA-R-ACE
- Acronym
- INCA R-ACE
- Status last verified
- Jul 2019
- First submitted
- 10 Dec 2015
- Last updated
- 18 Jul 2019
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Jul 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Risk Factors for Re-exacerbation After a Chronic Obstructive Pulmonary Disease (COPD) Exacerbation
- ClinicalTrials.gov ID
- NCT02644772
- Acronym / sponsor ID
- INCA R-ACE / INCA-R-ACE
- Keywords
- Acute Exacerbation of COPD, Clinical problems in COPD
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 207 participants (actual)
- Lead sponsor
- Beaumont HospitalUniversity, hospital or other
- Collaborators
- Royal College of Surgeons, Ireland
- Study start
- Oct 2015 (actual)
- Primary completion
- Jul 2017 (actual)
- Study completion
- Sep 2018 (actual)
- First posted
- 1 Jan 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 35 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients admitted to hospital with an acute exacerbation of COPD
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
18 secondary outcomes
Relationship between changes in IC and respiratory symptoms
Time frame: From admission to 30 days from hospitalisation with an exacerbation
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
Relationship between changes in Forced Vital Capacity and respiratory symptoms
Time frame: From admission to 30 days from hospitalisation with an exacerbation
Relationship between change in IC and quality of life scores
Time frame: From admission to 30 days from hospitalisation with an exacerbation
Relationship between change in FEV1 and quality of life scores
Time frame: From admission to 30 days from hospitalisation with an exacerbation
Relationship between change in FVC and quality of life scores
Time frame: From admission to 30 days from hospitalisation with an exacerbation
Relationship between change in IC and gait speed
Time frame: From admission to 30 days from hospitalisation with an exacerbation
Relationship between change in FEV1 and gait speed
Time frame: From admission to 30 days from hospitalisation with an exacerbation
Relationship between change in FVC and gait speed
Time frame: From admission to 30 days from hospitalisation with an exacerbation
Relationship between patient factors and subsequent exacerbation
Time frame: 90 days from hospitalisation with an exacerbation
Time to re-exacerbation
Time frame: 90 days from hospitalisation with an exacerbation
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
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
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
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
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
Relationship between Exacerbation factors and re-exacerbation
Time frame: 90 days from hospitalisation with an exacerbation
Relationship between Social and Environmental factors and subsequent exacerbation
Time frame: 90 days from hospitalisation with an exacerbation
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jul 2019.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Richard W Costello principal investigator
Beaumont Hospital, Dublin, Ireland
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Chronic Obstructive Pulmonary Disease (COPD), run by Beaumont Hospital at 1 site in Ireland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Jul 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Ireland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Jul 2019.