Clinical trial NCT02644772: Preventing Repeat Hospitalisations in Patients With Chronic Obstructive Pulmonary Disease (COPD)
Official title: Risk Factors for Re-exacerbation After a Chronic Obstructive Pulmonary Disease (COPD) Exacerbation
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Chronic Obstructive Pulmonary Disease (COPD)
Keywords: Acute Exacerbation of COPD
Clinical problems in COPD
Lead sponsor: Beaumont Hospital
Sponsor class: OTHER
Collaborators: name: Royal College of Surgeons, Ireland
First posted: 2016-01-01
Enrollment: 207
Sex: ALL
Minimum age (years): 35
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients admitted to hospital with an acute exacerbation of COPD

Brief 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.

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.

Eligibility criteria: 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

Primary outcomes:
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.
timeFrame: From admission to 90 days from hospitalisation with an exacerbation
Secondary outcomes:
measure: Relationship between changes in IC and respiratory symptoms
timeFrame: From admission to 30 days from hospitalisation with an exacerbation
measure: Relationship between changes in Forced Expiratory Volume in 1 second (FEV1) and respiratory symptoms
timeFrame: From admission to 30 days from hospitalisation with an exacerbation
measure: Relationship between changes in Forced Vital Capacity and respiratory symptoms
timeFrame: From admission to 30 days from hospitalisation with an exacerbation
measure: Relationship between change in IC and quality of life scores
timeFrame: From admission to 30 days from hospitalisation with an exacerbation
measure: Relationship between change in FEV1 and quality of life scores
timeFrame: From admission to 30 days from hospitalisation with an exacerbation
measure: Relationship between change in FVC and quality of life scores
timeFrame: From admission to 30 days from hospitalisation with an exacerbation
measure: Relationship between change in IC and gait speed
timeFrame: From admission to 30 days from hospitalisation with an exacerbation
measure: Relationship between change in FEV1 and gait speed
timeFrame: From admission to 30 days from hospitalisation with an exacerbation
measure: Relationship between change in FVC and gait speed
timeFrame: From admission to 30 days from hospitalisation with an exacerbation
measure: Relationship between patient factors and subsequent exacerbation
timeFrame: 90 days from hospitalisation with an exacerbation
measure: Time to re-exacerbation
timeFrame: 90 days from hospitalisation with an exacerbation
measure: Sensitivity of vital capacity measures taken with a bedside portable spirometer compared with those performed in the pulmonary function test laboratory
timeFrame: Day 3-7 of hospital admission
measure: Sensitivity of FEV1 measures taken with a bedside portable spirometer compared with those performed in the pulmonary function test laboratory
timeFrame: Day 3-7 of hospital admission
measure: Sensitivity of inspiratory capacity (IC) measured with a bedside portable spirometer and by the gold standard body plethysmography
timeFrame: Day 3-7 of hospital admission
measure: Change in vital capacity during an exacerbation and its relationship to re-exacerbation
timeFrame: At days 1-3 of admission, hospital discharge and 30 days from hospitalisation with an exacerbation
measure: Change in FEV1 during an exacerbation and its relationship to re-exacerbation
timeFrame: At days 1-3 of admission, hospital discharge and 30 days from hospitalisation with an exacerbation
measure: Relationship between Exacerbation factors and re-exacerbation
timeFrame: 90 days from hospitalisation with an exacerbation
measure: Relationship between Social and Environmental factors and subsequent exacerbation
timeFrame: 90 days from hospitalisation with an exacerbation
Other outcomes:
Locations:
city: Dublin
country: Ireland
facility: Beaumont Hospital
Study officials:
affiliation: Beaumont Hospital, Dublin, Ireland
name: Richard W Costello
role: PRINCIPAL_INVESTIGATOR
References: