NCT02552732

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 Health

60
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
29

participants targeted

Target at P25-P50 for not_applicable chronic-obstructive-pulmonary-disease

Timeline
Completed

Started Nov 2015

Geographic Reach
2 countries

2 active sites

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 15, 2015

Completed
2 days until next milestone

First Posted

Study publicly available on registry

September 17, 2015

Completed
2 months until next milestone

Study Start

First participant enrolled

November 1, 2015

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 3, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 3, 2017

Completed
3.2 years until next milestone

Results Posted

Study results publicly available

July 24, 2020

Completed
Last Updated

August 17, 2020

Status Verified

August 1, 2020

Enrollment Period

1.5 years

First QC Date

September 15, 2015

Results QC Date

July 19, 2018

Last Update Submit

August 6, 2020

Conditions

Chronic Obstructive Pulmonary DiseaseCOPD

Outcome Measures

Primary Outcomes (1)

  • 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

    30 days after hospital discharge

Secondary Outcomes (23)

  • Percentage of Days of Use, Adjusted for Number of Days With myAIRVO 2 at Home

    30 days after hospital discharge

  • Average Use Per Day of the myAIRVO 2 During Week 1

    First week after hospital discharge

  • Average Use Per Day of the myAIRVO 2 During Week 2

    Second week after hospital discharge

  • Average Use Per Day of the myAIRVO 2 During Week 3

    Third week after hospital discharge

  • Average Use Per Day of the myAIRVO 2 During Week 4

    Fourth week after hospital discharge

  • +18 more secondary outcomes

Study Arms (1)

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

Device: NHF with or without Oxygen

Interventions

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.

NHF with or without Oxygen

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Alana HealthCare

Liverpool, New York, 13088, United States

Location

Medical Research Institute of New Zealand

Wellington, 6242, New Zealand

Location

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Interventions

Oxygen Inhalation Therapy

Condition Hierarchy (Ancestors)

Lung Diseases, ObstructiveLung DiseasesRespiratory Tract DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Respiratory TherapyTherapeutics

Limitations and Caveats

Early termination leading to small numbers of subjects analyzed

Results Point of Contact

Title
Dr Stanislav Tatkov
Organization
Fisher and Paykel Healthcare
stanislav.tatkov@fphcare.co.nz
09 5740100

Study Officials

  • James Fingleton, MBChB

    Medical Research Institute of New Zealand

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DEVICE FEASIBILITY
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 15, 2015

First Posted

September 17, 2015

Study Start

November 1, 2015

Primary Completion

May 3, 2017

Study Completion

May 3, 2017

Last Updated

August 17, 2020

Results First Posted

July 24, 2020

Record last verified: 2020-08

Locations

NZ(1)US(1)