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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)
Scientific title
Aspiration and pulmonary outcomes in chronic obstructive pulmonary disease
Secondary ID [1] 300858 0
Nil
Universal Trial Number (UTN)
N/A
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Chronic obstructive pulmonary disease 316763 0
Condition category
Condition code
Respiratory 314994 314994 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
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.
Intervention code [1] 317182 0
Diagnosis / Prognosis
Comparator / control treatment
Reference comparator cohort are COPD patients without prandial aspiration
Control group
Active

Outcomes
Primary outcome [1] 323299 0
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.
Timepoint [1] 323299 0
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.
Secondary outcome [1] 381482 0
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.
Timepoint [1] 381482 0
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.

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.
Minimum age
40 Years
Maximum age
80 Years
Gender
Both males and females
Can healthy volunteers participate?
No
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

Study design
Purpose
Screening
Duration
Longitudinal
Selection
Defined population
Timing
Prospective
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.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 16157 0
Monash Medical Centre - Clayton campus - Clayton
Recruitment postcode(s) [1] 29696 0
3168 - Clayton

Funding & Sponsors
Funding source category [1] 305310 0
Hospital
Name [1] 305310 0
Monash Lung and Sleep, Monash Medical Centre
Address [1] 305310 0
Monash Medical Centre, 246 Clayton Road, Clayton, Victoria, 3168
Country [1] 305310 0
Australia
Primary sponsor type
Hospital
Name
Monash Medical Centre
Address
Monash Medical Centre, 246 Clayton Road, Clayton, Victoria, 3168
Country
Australia
Secondary sponsor category [1] 305675 0
None
Name [1] 305675 0
Address [1] 305675 0
Country [1] 305675 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 305649 0
Monash Health Human Research Ethics Committee
Ethics committee address [1] 305649 0
Monash Medical Centre, 246 Clayton Road, Clayton, Victoria, 3168
Ethics committee country [1] 305649 0
Australia
Date submitted for ethics approval [1] 305649 0
22/10/2014
Approval date [1] 305649 0
20/01/2015
Ethics approval number [1] 305649 0
14412A

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.
Trial website
N/A
Trial related presentations / publications
N/A
Public notes

Contacts
Principal investigator
Name 101086 0
Ms Lydia Cvejic
Address 101086 0
Monash Lung and Sleep, Monash Medical Centre, 246 Clayton Road, Clayton, Victoria, 3168
Country 101086 0
Australia
Phone 101086 0
+61 3 95942281
Fax 101086 0
+61 3 95946415
Email 101086 0
lydia.cvejic@monashhealth.org
Contact person for public queries
Name 101087 0
Ms Joanne McKenzie
Address 101087 0
Clinical Trials Coordinator, Monash Lung and Sleep, Monash Medical Centre, 246 Clayton Road, Clayton, Victoria, 3168
Country 101087 0
Australia
Phone 101087 0
+61 3 95942279
Fax 101087 0
+61 3 95946415
Email 101087 0
joanne.mckenzie@monashhealth.org
Contact person for scientific queries
Name 101088 0
Prof Philip Bardin
Address 101088 0
Monash Lung and Sleep, Monash Medical Centre, 246 Clayton Road, Clayton, Victoria, 3168
Country 101088 0
Australia
Phone 101088 0
+61 3 95942281
Fax 101088 0
+61 3 95946415
Email 101088 0
philip.bardin@monashhealth.org

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
What supporting documents are/will be available?
No other documents available
Summary results
Have study results been published in a peer-reviewed journal?
No
Other publications
Have study results been made publicly available in another format?
No
Results – basic reporting
Results – plain English summary