NCT04840706

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.

Trial Health

57
Monitor

Trial Health Score

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

Enrollment
3

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Apr 2022

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

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

April 9, 2021

Completed
3 days until next milestone

First Posted

Study publicly available on registry

April 12, 2021

Completed
1 year until next milestone

Study Start

First participant enrolled

April 21, 2022

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 30, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 30, 2024

Completed
Last Updated

December 29, 2025

Status Verified

December 1, 2025

Enrollment Period

2 years

First QC Date

April 9, 2021

Last Update Submit

December 19, 2025

Conditions

COPD

Outcome Measures

Primary Outcomes (2)

  • pCO2

    Improvement in daytime capillary pCO2 ≥ 0.5 kPa in the AirvoTM group compared to the standard care group

    1 year

  • 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

    1 year

Study Arms (2)

Airvo

ACTIVE COMPARATOR

Patients allocated to use Airvo device

Device: HFNC Airvo

Control

PLACEBO COMPARATOR

Patients not using Airvo, standard care

Other: Standard care

Interventions

HFNC AirvoDEVICE

HFNC device (Airvo) long-term use in in stabile hypercapnic COPD patients, who are non-compliant to NIV after an acute exacerbation of COPD

Airvo
Standard careOTHER

No HFNC treatment

Control

Eligibility Criteria

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Turku University Hospital

Turku, 20521, Finland

Location

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Interventions

Standard of Care

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Quality Indicators, Health CareQuality of Health CareHealth Services AdministrationHealth Care Quality, Access, and Evaluation

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

April 9, 2021

First Posted

April 12, 2021

Study Start

April 21, 2022

Primary Completion

April 30, 2024

Study Completion

April 30, 2024

Last Updated

December 29, 2025

Record last verified: 2025-12

Locations

FI(1)