Chronic Obstructive Pulmonary DiseaseN3ADSNCT02552732
Nasal High Flow Therapy 30 Day Readmission Study
A study testing NHF with or without Oxygen in people with Chronic Obstructive Pulmonary Disease and COPD, run by Fisher and Paykel Healthcare at 2 sites in 2 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Obstructive Pulmonary Disease, COPD
- What is being tested?
- NHF with or without Oxygen
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 29 participants
- Where
- 2 sitesin 2 countries
- Study dates
- Nov 2015to 3 May 2017
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
2 sites in 2 countries.
2 sites in 2 countries
New Zealand1 site
Medical Research Institute of New Zealand
Wellington, 6242
About this study
Official title: Nasal High Flow (NHF) Therapy Use Following Hospitalization for an Exacerbation of COPD: A Feasibility Study
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.
- Conditions
- Chronic Obstructive Pulmonary Disease, COPD
- Being tested
- NHF with or without Oxygen
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NHF with or without OxygenDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| NHF with or without Oxygen | Experimental | NHF with or without oxygen will be delivered to COPD patients using myAIRVO™ 2 for 30 days post hospital discharge Receives: Device: NHF with or without Oxygen |
What is being measured
The primary outcome is the main question the study is designed to answer.
NHF Use for 30 Days Following Discharge After AECOPD
Use will be expressed as hours of myAIRVO 2 use per day over 30 days, as obtained by myAIRVO 2 electronic monitoring
Measured: 30 days after hospital discharge
Secondary outcomes (23)
Percentage of Days of Use, Adjusted for Number of Days With myAIRVO 2 at Home
Measured: 30 days after hospital discharge
Average Use Per Day of the myAIRVO 2 During Week 1
Measured: First week after hospital discharge
Average Use Per Day of the myAIRVO 2 During Week 2
Measured: Second week after hospital discharge
Average Use Per Day of the myAIRVO 2 During Week 3
Measured: Third week after hospital discharge
Average Use Per Day of the myAIRVO 2 During Week 4
Measured: Fourth week after hospital discharge
Average Use Per Day on Days of myAIRVO 2 Use
Measured: 30 days after hospital discharge
Number of Participants Using Home Oxygen
Measured: At study entry
Number of Participants Who Reported Having Changed the myAIRVO 2 Flow Settings From the Initial Flow and the Corresponding Reduction in Flow
Measured: 30 days after hospital discharge
Number of Participants Who Where Screened But Were Excluded From Enrollment
Measured: 30 days after hospital discharge
Number of Participants Who Reported Having Changed the myAIRVO 2 Temperature Setting From the Initial Setting
Measured: 30 days after hospital discharge
Number of Participants Who Withdrew From Study After Enrollment, up to 30 Days
Number of participants who withdrew from study after enrollment, up to 30 days
Measured: At study completion
Number of Participants With at Least One Hospital Readmission Within 30 Days of Discharge
Measured: 30 days after hospital discharge
Reasons for Hospital Admissions
AECOPD, other respiratory cause or other cause
Measured: 30 days after hospital discharge
In Those That Had at Least One Hospital Readmission: Number of Readmissions
Measured: 30 days after hospital discharge
In Those That Had at Least One Hospital Readmission: Time to First Hospital Readmission
Measured: 30 days after hospital discharge
In Those That Had at Least One Hospital Readmission: Hospital Readmission Length
Measured: 30 days after hospital discharge
Number of Participants With at Least One ED Visit Within 30 Days of Discharge
Measured: 30 days after hospital discharge
Reason for ED Visits
ED visit due to AECOPD
Measured: 30 days after hospital discharge
Number of Participants With at Least One GP Visit Within 30 Days of Discharge
Measured: 30 days after hospital discharge
LACE Index for Hospital Admissions
The LACE Index is a scoring tool for assessing the likelihood of readmission or death within 30 days of discharge. It is based of 4 parameters: length of stay (L), acuity of the admission (A), co-morbidities (C), number of Emergency Department visits within the last 6 months (E). Sub scores for each parameter are summed to give a LACE score ranging from 1 to 19. A score of 0 to 4 = Low; 5 to 9 = Moderate; and a score of ≥ 10 = High risk of readmission.
Measured: 30 days after hospital discharge
FEV1 at Day 1 and 31
FEV1 change from day 1 to day 31
Measured: 1st and 31st day after hospital discharge
SVC(in) at Day 1 and 31
Slow Vital Capacity (inspiratory) change from day 1 to day 31
Measured: 1st and 31st day after hospital discharge
FVC Change From Day 1 to Day 31
Measured: 1st and 31st day after hospital discharge
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Sep 2015 (estimated)
- Study startNov 2015
- Primary completion3 May 2017
- Study completion3 May 2017
Why it stopped: Study terminated due to change in business of US site.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Chronic Obstructive Pulmonary DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Device feasibility
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 29 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fisher and Paykel Healthcare
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Medical Research Institute of New Zealand, Alana Healthcare
- Responsible party
- Sponsor
- Investigators
- James Fingleton, MBChB, Principal investigator, Medical Research Institute of New Zealand
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02552732
- Sponsor's protocol ID
- CIA138
- Acronym
- N3ADS
- Status last verified
- Aug 2020
- First submitted
- 15 Sep 2015
- Last updated
- 17 Aug 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 17 Aug 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Nasal High Flow (NHF) Therapy Use Following Hospitalization for an Exacerbation of COPD: A Feasibility Study
- ClinicalTrials.gov ID
- NCT02552732
- Acronym / sponsor ID
- N3ADS / CIA138
- Conditions
- Chronic Obstructive Pulmonary Disease, COPD
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Study terminated due to change in business of US site.
- Enrolment
- 29 participants (actual)
- Lead sponsor
- Fisher and Paykel HealthcareIndustry (pharma, biotech, devices)
- Collaborators
- Medical Research Institute of New Zealand, Alana Healthcare
- Study start
- Nov 2015
- Primary completion
- 3 May 2017 (actual)
- Study completion
- 3 May 2017 (actual)
- First posted
- 17 Sep 2015 (estimated)
- Results
- Posted 24 Jul 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Device feasibility
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| NHF with or without Oxygen | Experimental | Device: NHF with or without OxygenNHF with or without oxygen will be delivered to COPD patients using myAIRVO™ 2 for 30 days post hospital discharge |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| NHF with or without OxygenNHF 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. | Device | NHF with or without Oxygen |
Primary outcome
NHF Use for 30 Days Following Discharge After AECOPD
Time frame: 30 days after hospital discharge
Use will be expressed as hours of myAIRVO 2 use per day over 30 days, as obtained by myAIRVO 2 electronic monitoring
23 secondary outcomes
Percentage of Days of Use, Adjusted for Number of Days With myAIRVO 2 at Home
Time frame: 30 days after hospital discharge
Average Use Per Day of the myAIRVO 2 During Week 1
Time frame: First week after hospital discharge
Average Use Per Day of the myAIRVO 2 During Week 2
Time frame: Second week after hospital discharge
Average Use Per Day of the myAIRVO 2 During Week 3
Time frame: Third week after hospital discharge
Average Use Per Day of the myAIRVO 2 During Week 4
Time frame: Fourth week after hospital discharge
Average Use Per Day on Days of myAIRVO 2 Use
Time frame: 30 days after hospital discharge
Number of Participants Using Home Oxygen
Time frame: At study entry
Number of Participants Who Reported Having Changed the myAIRVO 2 Flow Settings From the Initial Flow and the Corresponding Reduction in Flow
Time frame: 30 days after hospital discharge
Number of Participants Who Where Screened But Were Excluded From Enrollment
Time frame: 30 days after hospital discharge
Number of Participants Who Reported Having Changed the myAIRVO 2 Temperature Setting From the Initial Setting
Time frame: 30 days after hospital discharge
Number of Participants Who Withdrew From Study After Enrollment, up to 30 Days
Time frame: At study completion
Number of Participants With at Least One Hospital Readmission Within 30 Days of Discharge
Time frame: 30 days after hospital discharge
Reasons for Hospital Admissions
Time frame: 30 days after hospital discharge
In Those That Had at Least One Hospital Readmission: Number of Readmissions
Time frame: 30 days after hospital discharge
In Those That Had at Least One Hospital Readmission: Time to First Hospital Readmission
Time frame: 30 days after hospital discharge
In Those That Had at Least One Hospital Readmission: Hospital Readmission Length
Time frame: 30 days after hospital discharge
Number of Participants With at Least One ED Visit Within 30 Days of Discharge
Time frame: 30 days after hospital discharge
Reason for ED Visits
Time frame: 30 days after hospital discharge
Number of Participants With at Least One GP Visit Within 30 Days of Discharge
Time frame: 30 days after hospital discharge
LACE Index for Hospital Admissions
Time frame: 30 days after hospital discharge
FEV1 at Day 1 and 31
Time frame: 1st and 31st day after hospital discharge
SVC(in) at Day 1 and 31
Time frame: 1st and 31st day after hospital discharge
FVC Change From Day 1 to Day 31
Time frame: 1st and 31st day after hospital discharge
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Aug 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
James Fingleton, MBChB principal investigator
Medical Research Institute of New Zealand
2 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing NHF with or without Oxygen in people with Chronic Obstructive Pulmonary Disease and COPD, run by Fisher and Paykel Healthcare at 2 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 17 Aug 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States, New Zealand. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 24 Jul 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
NHF Use for 30 Days Following Discharge After AECOPD (time frame: 30 days after hospital discharge). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Aug 2020.