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

NCT02644772 | Completed

• 1 other identifier: INCA-R-ACE
• Study Type: observational
• Target: 207
• Locations: 1 country
• Sites: 1

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.

Conditions

Chronic Obstructive Pulmonary Disease (COPD)

Keywords

Acute Exacerbation of COPD; Clinical problems in COPD

Outcome Measures

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.

  From admission to 90 days from hospitalisation with an exacerbation

Secondary Outcomes (18)

• Relationship between changes in IC and respiratory symptoms

  From admission to 30 days from hospitalisation with an exacerbation

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

  From admission to 30 days from hospitalisation with an exacerbation

• Relationship between changes in Forced Vital Capacity and respiratory symptoms

  From admission to 30 days from hospitalisation with an exacerbation

• Relationship between change in IC and quality of life scores

  From admission to 30 days from hospitalisation with an exacerbation

• Relationship between change in FEV1 and quality of life scores

  From admission to 30 days from hospitalisation with an exacerbation

Eligibility Criteria

• Age: 35 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients admitted to hospital with an acute exacerbation of COPD

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Beaumont Hospital: lead
• Royal College of Surgeons, Ireland: collaborator

Study Sites (1)

Beaumont Hospital

Dublin, Ireland

Location

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Richard W Costello

  Beaumont Hospital, Dublin, Ireland

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor Richard W Costello

Study Record Dates

• First Submitted: December 10, 2015
• First Posted: January 1, 2016
• Study Start: October 1, 2015
• Primary Completion: July 1, 2017
• Study Completion: September 1, 2018
• Last Updated: July 18, 2019

Record last verified: 2019-07

Locations

IE (1)