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Trial registered on ANZCTR
Registration number
ACTRN12620000513910
Ethics application status
Approved
Date submitted
27/03/2020
Date registered
27/04/2020
Date last updated
27/04/2020
Date data sharing statement initially provided
27/04/2020
Date results information initially provided
27/04/2020
Type of registration
Retrospectively registered
Titles & IDs
Public title
Aspiration in chronic obstructive pulmonary disease (COPD)
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Scientific title
Aspiration and pulmonary outcomes in chronic obstructive pulmonary disease
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Secondary ID [1]
300858
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Nil
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Universal Trial Number (UTN)
N/A
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Chronic obstructive pulmonary disease
316763
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Condition category
Condition code
Respiratory
314994
314994
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0
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Chronic obstructive pulmonary disease
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Intervention/exposure
Study type
Observational
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Patient registry
False
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Target follow-up duration
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Target follow-up type
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Description of intervention(s) / exposure
Baseline standardised measurements: spirometry, gas transfer, lung volumes by body plethysmography, exhaled nitric oxide (FENO), transcutaneous oximetry, respiratory rate, Airways Questionnaire 20 (AQ20), Eating Assessment Tool-10 (EAT-10), Oral Health Assessment Tool (OHAT), resting pH of unstimulated saliva, auditory perceptual voice evaluation and videofluoroscopy swallowing examination. Radiographic oral barium liquid solution was administered as part of standard videofluoroscopy procedure. Dose of oral barium solution was 100mL, taken twice within a 5-minute period during initial testing. Assessments were delivered individually by an experienced speech pathologist, respiratory scientists and radiographers within 1.5 hours.
Measurements performed at 6 months: above measurements repeated excluding OHAT, resting saliva pH, voice evaluation, respiratory rate and videofluoroscopy swallowing examination.
Measurements performed at 12 months: AQ20 and EAT-10 via telephone.
Measurements performed at 3, 6, 9, 12 months: Episodes of acute exacerbations of COPD (AECOPD) via telephone interviews using structured AECOPD questionnaire and examination of medical records.
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Intervention code [1]
317182
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Diagnosis / Prognosis
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Comparator / control treatment
Reference comparator cohort are COPD patients without prandial aspiration
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Control group
Active
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Outcomes
Primary outcome [1]
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Composite primary outcomes -proportion of patients with detectable aspiration based on videofluoroscopy and the number of patients with severe AECOPD using telephone interviews and patient medical records.
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Assessment method [1]
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Timepoint [1]
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Primary outcome 1: Aspiration detected at baseline (primary timepoint).
Primary outcome 2: Episodes of AECOPD detected at 3, 6, 9, 12 months (primary outcome timepoint) follow-up after initial testing commencement.
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Secondary outcome [1]
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Composite secondary outcomes -combined moderate and severe AECOPD events and changes from baseline measurements/mean in lung function, FENO, AQ20 and EAT-10 scores.
Measurements of spirometry, gas transfer, lung volumes by body plethysmography and FENO (MGC Diagnostics Medisoft and Aerocrine NIOX NO monitoring systems) obtained as per American Thoracic Society and European Respiratory Society guidelines.
Episodes of moderate AECOPD defined as worsening of COPD symptoms treated with antibiotics and/or systemic corticosteroids by the general practitioner without Emergency Department (ED) review or hospital admission. Severe AECOPD defined as worsening of COPD symptoms with ED admission with or without hospitalisation. Frequent exacerbation characterised as patients having more than one exacerbation per year.
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Assessment method [1]
381482
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Timepoint [1]
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3, 6, 9, and 12 months follow-up for AECOPD events. Baseline and at 6 months follow-up for lung function and FENO. Baseline, 6 months and 12 months follow-up for AQ20 and EAT-10.
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Eligibility
Key inclusion criteria
Verified diagnosis of COPD made by general practitioner or respiratory physician using international criteria/guidelines. Stable lung disease in the preceding 12 weeks prior to initial/baseline assessments.
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Minimum age
40
Years
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Maximum age
80
Years
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
Known neurological disease, significant head or neck surgery impacting swallow, history of head or neck cancer, abnormal cranial nerve function on examination, current smokers
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Study design
Purpose
Screening
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Duration
Longitudinal
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Selection
Defined population
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Timing
Prospective
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Statistical methods / analysis
The number of patients recruited to the study was based on previous research (Cvejic et al 2011 Laryngeal penetration and aspiration in individuals with stable COPD. Respirology 16 269-275.). It was anticipated that approximately 25% of patients with COPD would have detectable aspiration. For severe AECOPD is was assumed that the number of patients with aspiration and hospitalisation would be double compared to no aspiration over 12 months. To achieve statistical power of 80% with p value greater than or equal to 0.05 the study required 134 patients. To compensate for patients who may withdraw from the study (estimate 15%), 166 patients needed to be recruited. Statistical analysis using chi-square, contingency tables and logistic regression methods as appropriate.
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Recruitment
Recruitment status
Completed
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Date of first participant enrolment
Anticipated
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Actual
10/04/2015
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Date of last participant enrolment
Anticipated
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Actual
25/08/2017
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Date of last data collection
Anticipated
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Actual
17/10/2019
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Sample size
Target
166
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Accrual to date
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Final
151
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Recruitment in Australia
Recruitment state(s)
VIC
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Recruitment hospital [1]
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Monash Medical Centre - Clayton campus - Clayton
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Recruitment postcode(s) [1]
29696
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3168 - Clayton
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Funding & Sponsors
Funding source category [1]
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Hospital
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Name [1]
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Monash Lung and Sleep, Monash Medical Centre
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Address [1]
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Monash Medical Centre, 246 Clayton Road, Clayton, Victoria, 3168
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Country [1]
305310
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Australia
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Primary sponsor type
Hospital
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Name
Monash Medical Centre
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Address
Monash Medical Centre, 246 Clayton Road, Clayton, Victoria, 3168
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Country
Australia
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Secondary sponsor category [1]
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None
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Name [1]
305675
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Address [1]
305675
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Country [1]
305675
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Ethics approval
Ethics application status
Approved
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Ethics committee name [1]
305649
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Monash Health Human Research Ethics Committee
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Ethics committee address [1]
305649
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Monash Medical Centre, 246 Clayton Road, Clayton, Victoria, 3168
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Ethics committee country [1]
305649
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Australia
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Date submitted for ethics approval [1]
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22/10/2014
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Approval date [1]
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20/01/2015
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Ethics approval number [1]
305649
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14412A
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Summary
Brief summary
This study aims to provide proof of concept support for prevalence of aspiration and association with more frequent severe acute exacerbations in chronic obstructive pulmonary disease.
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Trial website
N/A
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Trial related presentations / publications
N/A
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Public notes
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Contacts
Principal investigator
Name
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Ms Lydia Cvejic
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Address
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Monash Lung and Sleep, Monash Medical Centre, 246 Clayton Road, Clayton, Victoria, 3168
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Country
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Australia
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Phone
101086
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+61 3 95942281
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Fax
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+61 3 95946415
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Email
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[email protected]
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Contact person for public queries
Name
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Ms Joanne McKenzie
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Address
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Clinical Trials Coordinator, Monash Lung and Sleep, Monash Medical Centre, 246 Clayton Road, Clayton, Victoria, 3168
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Country
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Australia
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Phone
101087
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+61 3 95942279
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Fax
101087
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+61 3 95946415
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Email
101087
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[email protected]
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Contact person for scientific queries
Name
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Prof Philip Bardin
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Address
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Monash Lung and Sleep, Monash Medical Centre, 246 Clayton Road, Clayton, Victoria, 3168
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Country
101088
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Australia
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Phone
101088
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+61 3 95942281
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Fax
101088
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+61 3 95946415
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Email
101088
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[email protected]
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Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
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No/undecided IPD sharing reason/comment
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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
Source
Title
Year of Publication
DOI
Embase
Aspiration and severe exacerbations in COPD: A prospective study.
2021
https://dx.doi.org/10.1183/23120541.00735-2020
N.B. These documents automatically identified may not have been verified by the study sponsor.
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