Trial Review

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial registered on ANZCTR


Registration number
ACTRN12618000736246
Ethics application status
Approved
Date submitted
27/04/2018
Date registered
2/05/2018
Date last updated
25/06/2018
Type of registration
Prospectively registered

Titles & IDs
Public title
Can the levels of exhaled nitric oxide during an acute exacerbation of COPD predict which patients will be at higher risk of further hospital admissions over the next twelve months?
Scientific title
Expired Nitrous Oxide predicting ReADmission (NORAD) study: A prospective cohort study to evaluate fractional exhaled nitric oxide levels in hospitalised patients with acute exacerbations of chronic obstructive lung disease and the risk of hospital readmission.
Secondary ID [1] 294681 0
Nil Known
Universal Trial Number (UTN)
U1111-1212-7372
Trial acronym
NORAD (expired Nitrous Oxide predicting ReADmission) study
Linked study record
Not applicable

Health condition
Health condition(s) or problem(s) studied:
Acute Exacerbations of Chronic Obstructive Pulmonary Disease 307551 0
Hospital Readmission 307552 0
Condition category
Condition code
Respiratory 306631 306631 0 0
Chronic obstructive pulmonary disease

Intervention/exposure
Study type
Observational
Patient registry
False
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
This study will assess the impact of fractional exhaled Nitric Oxide (FeNO) in people admitted to hospital with an acute exacerbation of Chronic Obstructive Pulmonary Disease (AECOPD) on 12-month readmission risk for AECOPD.
The FeNO will be measured once within 24 hours of admission using the NIOX VERO device.
Additional known and hypothesised confounders of hospital readmission will be measured once within 24 hours of admission including 1) patient demographics, 2) Spirometry using the EasyOne Spirometer, 3) Severity of COPD using the COPD Assessment Test, 4) breathlessness using the Modified MRC dyspnoea scale, 5) medical co-morbidities using the Charlson Comorbidity Index, 6) anxiety using the Hospital Anxiety and Depression scale and 7) laboratory evidence of allergy and with blood eosinophil level, IgE level and RAST f or dust mite, pollen, animal and mould mix.
These measurements will be administered in conjunction with a member of the study team (respiratory specialists or respiratory registrar or respiratory clinical nurse). Blood tests will be obtained from blood samples obtained at admission by emergency medicine staff as part of routine care. Any remaining blood tests will be additionally requested.
Intervention code [1] 300985 0
Diagnosis / Prognosis
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 305684 0
Hospital readmission for COPD exacerbation - assessed by discharge summary with discharge diagnosis as "exacerbation of COPD". Sources of discharge summary will be the institution's electronic medical record or general practice records.
Timepoint [1] 305684 0
12 months post-discharge
Secondary outcome [1] 346167 0
Repeat exacerbation of COPD - determined by patient, carer or general practitioner self-report
Timepoint [1] 346167 0
12 months post-discharge. This outcome will be assessed at intervals of 6 weeks, 3 months, 6 months, 9 months and 12 months post-discharge (+/- 1 week).
Secondary outcome [2] 346168 0
Time to hospital readmission for COPD exacerbation determined by time in days from discharge to readmission based on available discharge summary documentation.
Timepoint [2] 346168 0
12 months post-discharge

Eligibility
Key inclusion criteria
• Age greater than or equal to 40 years
• Smoking history of greater than or equal to 15 pack years
• Suspected or Known COPD defined as a FEV1/FVC ratio of <70% on spirometry
• Hospital admission with primary diagnosis of AECOPD
Minimum age
40 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
• Patients who do not have airflow obstruction on spirometry (FEV1/FVC<70%)
• Patients in acute respiratory failure requiring non-invasive positive pressure ventilation or invasive mechanical ventilation
• Patients requiring ionotropic support
• Patients with concurrent diagnosis of bronchiectasis, interstitial lung disease, pulmonary embolism or acute cardiac failure
• Overseas and Interstate visitors

Study design
Purpose
Natural history
Duration
Longitudinal
Selection
Convenience sample
Timing
Prospective
Statistical methods / analysis
Predictors for the primary outcome (readmission for COPD exacerbation) will be identified by using a multivariate logistic regression model incorporating FeNO level and other known and suspected factors associated with COPD readmissions. Associations between FeNO and readmission will be presented as odds ratios. Systemic steroids can affect FeNO measurements. Therefore, outcomes will also be analysed by dose of systemic corticosteroid prior to FeNO measurement.

Predictors of the secondary outcomes (time to readmission for repeat exacerbation of COPD and time to repeat exacerbation) will be identified by using a Cox Proportional Hazards regression model or logistic regression model as appropriate incorporating FeNO level and other known and suspected factors associated with COPD readmissions. Associations between FeNO and readmission will be presented as hazard ratios (Cox Proportional Hazards model) or odds ratios (logistic regression model).

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
28/05/2018
Actual
30/05/2018
Date of last participant enrolment
Anticipated
27/05/2019
Actual
Date of last data collection
Anticipated
28/05/2020
Actual
Sample size
Target
80
Accrual to date
4
Final
Recruitment in Australia
Recruitment state(s)
WA
Recruitment hospital [1] 10801 0
St John of God Midland Public Hospital - Midland
Recruitment postcode(s) [1] 22541 0
6056 - Midland

Funding & Sponsors
Funding source category [1] 299289 0
Hospital
Name [1] 299289 0
St John of God Hospital Midland
Country [1] 299289 0
Australia
Primary sponsor type
Hospital
Name
St John of God Hospital Midland
Address
1 Clayton St, Midland, WA, 6056
Country
Australia
Secondary sponsor category [1] 298557 0
None
Name [1] 298557 0
Address [1] 298557 0
Country [1] 298557 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 300200 0
St John of God Healthcare
Ethics committee address [1] 300200 0
Suite 304, 25 McCourt St, Subiaco, WA, 6008
Ethics committee country [1] 300200 0
Australia
Date submitted for ethics approval [1] 300200 0
Approval date [1] 300200 0
17/04/2018
Ethics approval number [1] 300200 0
1370

Summary
Brief summary
Nitric oxide (NO) has been implicated in the pathophysiology of lung diseases. NO is produced in the lung and can be measured in exhaled breath. The measurement of fractional exhaled nitrous oxide (FeNO) has now been standardized and there is evidence regarding its clinical use in asthma. However, the exact clinical role of FeNO remains poorly investigated in the context of Chronic Obstructive Pulmonary Disease (COPD).
COPD is a leading cause of disability and mortality. Patients with COPD are prone to recurrent exacerbations that can affect quality of life and lung function. Exacerbation prevention is therefore an important goal of COPD management.
This study aims to clarify the role of FeNO measurement in the setting of hospitalized COPD exacerbations and assess its association with risk of readmission. Identifying patients at greater risk of readmission may potentially help target interventions in this population.
Trial website
Trial related presentations / publications
Public notes
Attachments [1] 2638 2638 0 0
/AnzctrAttachments/374957-NORAD Protocol Version 1.2.pdf (Protocol)
Attachments [2] 2639 2639 0 0
/AnzctrAttachments/374957-PIS and Consent form version 1.1 December 2017.pdf (Participant information/consent)
Attachments [3] 2640 2640 0 0
/AnzctrAttachments/374957-#1370 20180417 Ethics Approval.pdf (Ethics approval)

Contacts
Principal investigator
Name 82886 0
Dr Francesco Piccolo
Address 82886 0
Midland Physician Service
St John of God Hospital Midland
1 Clayton St, Midland, WA, 6056
Country 82886 0
Australia
Phone 82886 0
+61 8 9462 5300
Fax 82886 0
+61 8 9462 5270
Email 82886 0
[email protected]
Contact person for public queries
Name 82887 0
Dr Francesco Piccolo
Address 82887 0
Midland Physician Service
St John of God Hospital Midland
1 Clayton St, Midland, WA, 6056
Country 82887 0
Australia
Phone 82887 0
+61 8 9462 5300
Fax 82887 0
+61 8 9462 5270
Email 82887 0
[email protected]
Contact person for scientific queries
Name 82888 0
Dr Francesco Piccolo
Address 82888 0
Midland Physician Service
St John of God Hospital Midland
1 Clayton St, Midland, WA, 6056
Country 82888 0
Australia
Phone 82888 0
+61 8 9462 5300
Fax 82888 0
+61 8 9462 5270
Email 82888 0
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.