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

NCT ID: NCT04840706

Last Updated: 2025-12-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

NA

Total Enrollment

3 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-04-21

Study Completion Date

2024-04-30

Brief Summary

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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

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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.

Conditions

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COPD

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Airvo

Patients allocated to use Airvo device

Group Type ACTIVE_COMPARATOR

HFNC Airvo

Intervention Type DEVICE

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

Control

Patients not using Airvo, standard care

Group Type PLACEBO_COMPARATOR

Standard care

Intervention Type OTHER

No HFNC treatment

Interventions

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HFNC Airvo

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 DEVICE

Standard care

No HFNC treatment

Intervention Type OTHER

Eligibility Criteria

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Inclusion 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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Turku University Hospital

OTHER_GOV

Sponsor Role lead

Responsible Party

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Tarja Saaresranta

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Turku University Hospital

Turku, , Finland

Site Status

Countries

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Finland

Other Identifiers

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MyAirvo

Identifier Type: -

Identifier Source: org_study_id