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Open-Label Prospective Study Comparing Long-Term Outcome With or Without HFNC in Patients With Stable Hypercapnic COPD (MyAirvo)

Primary Purpose

COPD

Status
Recruiting
Phase
Not Applicable
Locations
Finland
Study Type
Interventional
Intervention
HFNC Airvo
Standard care
Sponsored by
Turku University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for COPD

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:COPD patients 1) with at least two acute moderate or severe exacerbations during past 12 months, 2) who at the follow-up visit one month after an acute severe exacerbation of COPD are hypercapnic (capillary pCO2 >6.5 kPa) and not willing to use NIV or have used it less than 4 h/d during the last month despite optimal settings prescribed by an experienced pulmonologist, or if a patient at the follow-up one month after a severe exacerbation is hypercapnic and is willing to try NIV (initiated at the follow-up visit, not at the ward), but then uses it less than 4h/d during the following month. Acute moderate (treated with short acting bronchodilators plus antibiotics and/or oral corticosteroids) and severe (patient requires hospitalization or visits the emergency room) exacerbations of COPD are defined according to the GINA Guidelines (GOLD 2019).

Exclusion Criteria: 1) OSA (diagnosed OSA or high suspicion OSA because of regular snoring, witnessed apneas and daytime sleepiness), 2) neuromuscular or chest wall disease, 3) BMI>35 kg/m2 or 4) a patient is not able to give his/her informed consent for the study.

Sites / Locations

  • Turku University HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Airvo

Control

Arm Description

Patients allocated to use Airvo device

Patients not using Airvo, standard care

Outcomes

Primary Outcome Measures

pCO2
Improvement in daytime capillary pCO2 ≥ 0.5 kPa in the AirvoTM group compared to the standard care group
Acute exacerbation rate
decrease in acute exacerbation (moderate or severe) rate of COPD in AirvoTM group compared to the previous 12 months before entering the study and standard care group

Secondary Outcome Measures

Full Information

First Posted
April 9, 2021
Last Updated
June 13, 2022
Sponsor
Turku University Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT04840706
Brief Title
Open-Label Prospective Study Comparing Long-Term Outcome With or Without HFNC in Patients With Stable Hypercapnic COPD
Acronym
MyAirvo
Official Title
Open-Label Prospective Study Comparing Long-Term Outcome With or Without High-flow Nasal Cannula AirvoTM in Patients With Stable Hypercapnic COPD
Study Type
Interventional

2. Study Status

Record Verification Date
June 2022
Overall Recruitment Status
Recruiting
Study Start Date
April 20, 2021 (Actual)
Primary Completion Date
December 31, 2022 (Anticipated)
Study Completion Date
December 31, 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Turku University Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
The aims of the study are to compare long-term one-year outcome with or without AirvoTM in stabile hypercapnic COPD patients, who are non-compliant to NIV after an acute exacerbation of COPD.
Detailed Description
When compared to NIV, much less experience is available from clinical studies on HFNC therapy. Until now, few studies have investigated the effect of HFNC therapy on hypercapnic COPD patients and the number of patients recruited in these studies is limited. AirvoTM therapy could be good choice of treatment for those COPD patients that are not compliant to NIV but need treatment for hypercapnia in order to reduce COPD exacerbations and enhance QOL.The aims of the study are to compare long-term one-year outcome with or without AirvoTM in stabile hypercapnic COPD patients, who are non-compliant to NIV after an acute exacerbation of COPD.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
COPD

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
94 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Airvo
Arm Type
Active Comparator
Arm Description
Patients allocated to use Airvo device
Arm Title
Control
Arm Type
Placebo Comparator
Arm Description
Patients not using Airvo, standard care
Intervention Type
Device
Intervention Name(s)
HFNC Airvo
Intervention Description
HFNC device (Airvo) long-term use in in stabile hypercapnic COPD patients, who are non-compliant to NIV after an acute exacerbation of COPD
Intervention Type
Other
Intervention Name(s)
Standard care
Intervention Description
No HFNC treatment
Primary Outcome Measure Information:
Title
pCO2
Description
Improvement in daytime capillary pCO2 ≥ 0.5 kPa in the AirvoTM group compared to the standard care group
Time Frame
1 year
Title
Acute exacerbation rate
Description
decrease in acute exacerbation (moderate or severe) rate of COPD in AirvoTM group compared to the previous 12 months before entering the study and standard care group
Time Frame
1 year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:COPD patients 1) with at least two acute moderate or severe exacerbations during past 12 months, 2) who at the follow-up visit one month after an acute severe exacerbation of COPD are hypercapnic (capillary pCO2 >6.5 kPa) and not willing to use NIV or have used it less than 4 h/d during the last month despite optimal settings prescribed by an experienced pulmonologist, or if a patient at the follow-up one month after a severe exacerbation is hypercapnic and is willing to try NIV (initiated at the follow-up visit, not at the ward), but then uses it less than 4h/d during the following month. Acute moderate (treated with short acting bronchodilators plus antibiotics and/or oral corticosteroids) and severe (patient requires hospitalization or visits the emergency room) exacerbations of COPD are defined according to the GINA Guidelines (GOLD 2019). Exclusion Criteria: 1) OSA (diagnosed OSA or high suspicion OSA because of regular snoring, witnessed apneas and daytime sleepiness), 2) neuromuscular or chest wall disease, 3) BMI>35 kg/m2 or 4) a patient is not able to give his/her informed consent for the study.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Tarja Saaresranta
Phone
0407401149
Email
tasaare@utu.fi
Facility Information:
Facility Name
Turku University Hospital
City
Turku
ZIP/Postal Code
20521
Country
Finland
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Tarja a Saaresranta, MD
Phone
0407401149
Email
tasaare@utu.fi

12. IPD Sharing Statement

Learn more about this trial

Open-Label Prospective Study Comparing Long-Term Outcome With or Without HFNC in Patients With Stable Hypercapnic COPD

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