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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/ct2/show/NCT04947852
Registration number
NCT04947852
Ethics application status
Date submitted
24/06/2021
Date registered
1/07/2021
Date last updated
18/03/2022
Titles & IDs
Public title
Efficacy of NIV Masks in COPD
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Scientific title
Efficacy of NIV Masks in COPD Patients With Chronic Respiratory Failure: A Randomized Controlled Cross Over Pilot
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Secondary ID [1]
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CIA293
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Universal Trial Number (UTN)
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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:
COPD
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Condition category
Condition code
Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Treatment: Devices - Investigation Mask
Treatment: Devices - Comparator Mask
Experimental: Investigation Mask - Bi Level CPAP Mask
Active Comparator: Comparator Mask - Bi Level CPAP Mask
Treatment: Devices: Investigation Mask
Oronasal bilevel continuous positive airway pressure mask fitted by the investigational staff
Treatment: Devices: Comparator Mask
Oronasal bilevel continuous positive airway pressure mask fitted by the investigational staff
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Intervention code [1]
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Treatment: Devices
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Transcutaneous Carbon Dioxide
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Assessment method [1]
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mmHg
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Timepoint [1]
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60 minutes
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Secondary outcome [1]
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Oxygen Saturation
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Assessment method [1]
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Percentage
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Timepoint [1]
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60 minutes
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Secondary outcome [2]
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Minute Ventilation
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Assessment method [2]
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Litres
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Timepoint [2]
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60 minutes
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Secondary outcome [3]
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Heart Rate
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Assessment method [3]
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Beats per minute
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Timepoint [3]
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60 minutes
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Secondary outcome [4]
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Respiratory Rate
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Assessment method [4]
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Breaths per minute
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Timepoint [4]
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60 minutes
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Secondary outcome [5]
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Borg Dyspnoea Score
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Assessment method [5]
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1-6 Ranking, with 1 being best and 6 being worst
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Timepoint [5]
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60 Minutes
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Eligibility
Key inclusion criteria
- A doctor's diagnosis of COPD
- PtCO2 =45mmHg on transcutaneous monitor at baseline measure
- Oxygen saturation measured by pulse oximetry (SpO2) =85%
- Fits the study mask
- Can tolerate the therapy
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Minimum age
18
Years
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Maximum age
No limit
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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
- FEV1/FVC =70%
- Body mass index >35
- Hypercapnia considered to be primarily due to Obesity Hypoventilation syndrome and/or
Obstructive Sleep Apnea
- Any condition which makes NIV contra-indicated as per BTS guidelines based on clinical
judgement
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Study design
Purpose of the study
Basic Science
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Open (masking not used)
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Who is / are masked / blinded?
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Intervention assignment
Crossover
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Other design features
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Phase
Not Applicable
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Completed
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
28/07/2021
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
17/03/2022
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Sample size
Target
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Accrual to date
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Final
16
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Recruitment in Australia
Recruitment state(s)
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Recruitment outside Australia
Country [1]
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New Zealand
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State/province [1]
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Wellington
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Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
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Name
Fisher and Paykel Healthcare
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Address
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Country
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Ethics approval
Ethics application status
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Summary
Brief summary
A randomized controlled pilot study to compare the efficacy and tolerability of a two
different NIV masks on carbon dioxide in participants with stable chronic obstructive
pulmonary disease (COPD) with chronic type II respiratory failure.
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Trial website
https://clinicaltrials.gov/ct2/show/NCT04947852
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Alex Semprini
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Address
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Medical Research Institute of New Zealand
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Country
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Phone
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Fax
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Email
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Contact person for public queries
Name
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Address
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0
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Country
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0
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Phone
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Fax
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Email
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Contact person for scientific queries
Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT04947852
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