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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/NCT02552732




Registration number
NCT02552732
Ethics application status
Date submitted
15/09/2015
Date registered
17/09/2015
Date last updated
17/08/2020

Titles & IDs
Public title
Nasal High Flow Therapy 30 Day Readmission Study
Scientific title
Nasal High Flow (NHF) Therapy Use Following Hospitalization for an Exacerbation of COPD: A Feasibility Study
Secondary ID [1] 0 0
CIA138
Universal Trial Number (UTN)
Trial acronym
N3ADS
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Chronic Obstructive Pulmonary Disease 0 0
COPD 0 0
Condition category
Condition code
Respiratory 0 0 0 0
Chronic obstructive pulmonary disease

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Devices - NHF with or without Oxygen

Experimental: NHF with or without Oxygen - NHF with or without oxygen will be delivered to COPD patients using myAIRVO™ 2 for 30 days post hospital discharge


Treatment: Devices: NHF with or without Oxygen
NHF using myAIRVO™ 2 will be set at 25L/min at 37°C. However, all participants are able to lower the delivered temperature to 34°C.
Intervention code [1] 0 0
Treatment: Devices
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
NHF Use for 30 Days Following Discharge After AECOPD
Timepoint [1] 0 0
30 days after hospital discharge
Secondary outcome [1] 0 0
Percentage of Days of Use, Adjusted for Number of Days With myAIRVO 2 at Home
Timepoint [1] 0 0
30 days after hospital discharge
Secondary outcome [2] 0 0
Average Use Per Day of the myAIRVO 2 During Week 1
Timepoint [2] 0 0
First week after hospital discharge
Secondary outcome [3] 0 0
Average Use Per Day of the myAIRVO 2 During Week 2
Timepoint [3] 0 0
Second week after hospital discharge
Secondary outcome [4] 0 0
Average Use Per Day of the myAIRVO 2 During Week 3
Timepoint [4] 0 0
Third week after hospital discharge
Secondary outcome [5] 0 0
Average Use Per Day of the myAIRVO 2 During Week 4
Timepoint [5] 0 0
Fourth week after hospital discharge
Secondary outcome [6] 0 0
Average Use Per Day on Days of myAIRVO 2 Use
Timepoint [6] 0 0
30 days after hospital discharge
Secondary outcome [7] 0 0
Number of Participants Using Home Oxygen
Timepoint [7] 0 0
At study entry
Secondary outcome [8] 0 0
Number of Participants Who Reported Having Changed the myAIRVO 2 Flow Settings From the Initial Flow and the Corresponding Reduction in Flow
Timepoint [8] 0 0
30 days after hospital discharge
Secondary outcome [9] 0 0
Number of Participants Who Where Screened But Were Excluded From Enrollment
Timepoint [9] 0 0
30 days after hospital discharge
Secondary outcome [10] 0 0
Number of Participants Who Reported Having Changed the myAIRVO 2 Temperature Setting From the Initial Setting
Timepoint [10] 0 0
30 days after hospital discharge
Secondary outcome [11] 0 0
Number of Participants Who Withdrew From Study After Enrollment, up to 30 Days
Timepoint [11] 0 0
At study completion
Secondary outcome [12] 0 0
Number of Participants With at Least One Hospital Readmission Within 30 Days of Discharge
Timepoint [12] 0 0
30 days after hospital discharge
Secondary outcome [13] 0 0
Reasons for Hospital Admissions
Timepoint [13] 0 0
30 days after hospital discharge
Secondary outcome [14] 0 0
In Those That Had at Least One Hospital Readmission: Number of Readmissions
Timepoint [14] 0 0
30 days after hospital discharge
Secondary outcome [15] 0 0
In Those That Had at Least One Hospital Readmission: Time to First Hospital Readmission
Timepoint [15] 0 0
30 days after hospital discharge
Secondary outcome [16] 0 0
In Those That Had at Least One Hospital Readmission: Hospital Readmission Length
Timepoint [16] 0 0
30 days after hospital discharge
Secondary outcome [17] 0 0
Number of Participants With at Least One ED Visit Within 30 Days of Discharge
Timepoint [17] 0 0
30 days after hospital discharge
Secondary outcome [18] 0 0
Reason for ED Visits
Timepoint [18] 0 0
30 days after hospital discharge
Secondary outcome [19] 0 0
Number of Participants With at Least One GP Visit Within 30 Days of Discharge
Timepoint [19] 0 0
30 days after hospital discharge
Secondary outcome [20] 0 0
LACE Index for Hospital Admissions
Timepoint [20] 0 0
30 days after hospital discharge
Secondary outcome [21] 0 0
FEV1 at Day 1 and 31
Timepoint [21] 0 0
1st and 31st day after hospital discharge
Secondary outcome [22] 0 0
SVC(in) at Day 1 and 31
Timepoint [22] 0 0
1st and 31st day after hospital discharge
Secondary outcome [23] 0 0
FVC Change From Day 1 to Day 31
Timepoint [23] 0 0
1st and 31st day after hospital discharge

Eligibility
Key inclusion criteria
- 18 years of age or older

- Male and female

- Admitted to the respiratory ward(s) of either recruiting hospitals with AECOPD as the
primary diagnostic reason for admission.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
- Given a new home oxygen therapy prescription during the current hospital admission

- The investigator believes the participant or their care giver will be unable to safely
use the myAIRVO 2 device following discharge

- They have any other condition which, at the investigator's discretion, is believed may
present a safety risk or impact the feasibility of the study or the study results

Study design
Purpose of the study
Device Feasibility
Allocation to intervention
N/A
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Terminated
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/11/2015
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
3/05/2017
Sample size
Target
Accrual to date
Final
29
Recruitment in Australia
Recruitment state(s)
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
New York
Country [2] 0 0
New Zealand
State/province [2] 0 0
Wellington

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Fisher and Paykel Healthcare
Address
Country
Other collaborator category [1] 0 0
Other
Name [1] 0 0
Medical Research Institute of New Zealand
Address [1] 0 0
Country [1] 0 0
Other collaborator category [2] 0 0
Other
Name [2] 0 0
Alana Healthcare
Address [2] 0 0
Country [2] 0 0

Ethics approval
Ethics application status

Summary
Brief summary
The aim of this feasibility study is to provide data for a subsequent randomized controlled
trial to investigate if patient outcomes will be improved after an acute COPD exacerbation
using domiciliary nasal high flow therapy (NHF) compared to standard care. This feasibility
study will investigate the following: process, resources, management and scientific aspects
of delivering NHF as an adjunct therapy in COPD patients.
Trial website
https://clinicaltrials.gov/ct2/show/NCT02552732
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
James Fingleton, MBChB
Address 0 0
Medical Research Institute of New Zealand
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT02552732