Mechanisms of COPD Exacerbation Recurrence

Pulmonary Disease, Chronic Obstructive Clinical Trial

Official title:

Mechanisms of COPD Exacerbation Recurrence

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04024735
• Other study ID #: 21022
• Status: Recruiting
• Start date: June 1, 2019
• Est. completion date: May 1, 2022

Study information

• Verified date: July 2019
• Source: University College, London
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

Chronic obstructive pulmonary disease (COPD) is a common smoking-related lung disease. Patients with COPD are at increased risk of readmission to hospitals within the following 30 days. Hospital readmissions of COPD contribute to clinical and economic burden on society. Understanding why some COPD patients are readmitted remains a key area of unmet need.

To our knowledge, no previous study has fully investigated both the social and clinical risk factors associated with these types of patients. The investigators want to prospectively and comprehensively explore the possible causes, whether clinical or social factors, that cause rehospitalisation. The investigators will be collecting demographic and clinical information including daily physical activity level, lung function, blood and sputum samples. These measurements will be collected at patient admission, discharge and at follow-up of 30 and 90 days. This process could lead to a better understanding of the reasons which prevent early hospital readmission for those patients.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 166
• Est. completion date: May 1, 2022
• Est. primary completion date: February 1, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Patients who have a primary diagnosis of COPD

• Patients admitted to hospital with an exacerbation.

Exclusion Criteria:

• Patients in whom an initial diagnosis of an AECOPD is revised to an alternative at a later phase of the study.

• Patients who have a predominant history of asthma

• Patients with a confirmed active malignancy

• Patients who have a predominant history of bronchiectasis.

• Cognitive impairment patients with a Mental Test Score (MTS) of 6 or less.

• Inability to give informed consent to take part in the study

Related Conditions & MeSH terms

• Chronic Disease
• COPD Exacerbation
• Lung Diseases
• Patient Readmission
• Pulmonary Disease, Chronic Obstructive
• Recurrence

Intervention

Diagnostic Test:
• Spirometry, Forced Oscillation Technique, Step-counter, sputum and blood samples
We will be collecting demographic and clinical information including daily physical activity level, lung function, blood and sputum samples. These measurements will be collected at patient admission, discharge and at follow-up of 30 and 90 days.

Locations

Country	Name	City	State
United Kingdom	Royal Free Hospital NHS	London

Sponsors (1)

Lead Sponsor	Collaborator
University College, London

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The primary outcome is the factors that determine readmission to hospital within 30 and 90 days post discharge.		30 and 90 days
Secondary	Readmission rate at 30 days and at 3 months		30 and 90 days
Secondary	Prevalence of comorbidities between those who are and are not readmitted within 30 and 90 days.		30 and 90 days
Secondary	Changes in admission-to-discharge in within breath reactance (?Xrs5Hz) between patients who are and are not readmitted to the hospital within 30 and 90 days.		30 and 90 days
Secondary	Change in the modified Medical Research Council scale (mMRC) at admission, discharge and after 30 days follow-up or at readmission.	It is used to scale breathlessness, ranges from 0 to 4 which higher values represent a worse outcome.	30 and 90 days
Secondary	Change in quality of life by measuring COPD assessment test (CAT) at admission, discharge and after 30 days follow-up or at readmission.	It is used to scale patient's quality of life. Range of CAT scores from 0-40 which higher scores denote a more severe impact of COPD on a patient's life.	30 and 90 days
Secondary	Change in Hospital Anxiety and Depression Scale (HADS) at admission, discharge and after 30 days follow-up or at readmission.	It is used to scale patient's quality of life. The questionnaire comprises seven questions for anxiety and seven questions for depression. Each item on the questionnaire is scored from 0-3 and this means that a person can score between 0 and 21 for either anxiety or depression. The higher score indicates a worse outcome.	30 and 90 days
Secondary	Prevalence of frailty between those who are and are not readmitted to the hospital within 30 and 90 days.		30 and 90 days
Secondary	Change in physical activity level (daily steps) following the discharge between patients who are and are not readmitted.	Step counter (pedometer) will be given to wear throughout the 30 days period to measure the daily steps.	30 days
Secondary	Changes in admission-to-discharge peak inspiration flow rate (PIFR) between patients who are and are not readmitted.	The In-Check DIAL device will be used which is capable of measuring inspiratory flow rates between 0 and 120 L/min. Optimal PIFR, more than 60 L/min; and sub-optimal PIFR, 60 L/min or less).	30 and 90 days
Secondary	Change in white cell count (WCC) blood biomarkers	At admission, discharge and at readmission.	30 and 90 days
Secondary	Change in C-reactive protein (CRP) blood biomarker	At admission, discharge and at readmission.	30 and 90 days
Secondary	Change in Eosinophils blood biomarker	At admission, discharge and at readmission.	30 and 90 days
Secondary	Change in Neutrophils blood biomarker	At admission, discharge and at readmission.	30 and 90 days
Secondary	Change in troponin blood biomarker	At admission, discharge and at readmission.	30 and 90 days
Secondary	Change in B-type Natriuretic Peptide (BNP) blood biomarker	At admission, discharge and at readmission.	30 and 90 days
Secondary	Change in procalcitonin blood biomarker	At admission, discharge and at readmission.	30 and 90 days
Secondary	Change in fibrinogen blood biomarker	At admission, discharge and at readmission.	30 and 90 days
Secondary	Change in sputum biomarkers	This is used to assess bacteria species, load and resistance to antibiotics, and markers of inflammation such as IL-8.	30 and 90 days
Secondary	Number of hospital admissions in the previous year.	The investigators will record it to find the difference between patients who are and are not readmitted to the hospital within 30 and 90 days.	30 and 90 days
Secondary	Number of exacerbations in the previous year.	The investigators will record it to find the difference between patients who are and are not readmitted to the hospital within 30 and 90 days.	30 and 90 days
Secondary	Use of long-term oxygen therapy (LTOT)	The investigators will record it to find the difference between patients who are and are not readmitted to the hospital within 30 and 90 days.	30 and 90 days
Secondary	Length of stay (LOS) in hospital	The investigators will record it to find the difference between patients who are and are not readmitted to the hospital within 30 and 90 days.	30 and 90 days
Secondary	Use of non-invasive ventilation (NIV)	The investigators will record it to find the difference between patients who are and are not readmitted to the hospital within 30 and 90 days.	30 and 90 days
Secondary	Previous admission to the ICU	The investigators will record it to find the difference between patients who are and are not readmitted to the hospital within 30 and 90 days.	30 and 90 days