COPDMyAirvoNCT04840706
Open-Label Prospective Study Comparing Long-Term Outcome With or Without HFNC in Patients With Stable Hypercapnic COPD
A study testing HFNC Airvo in people with COPD, run by Turku University Hospital at 1 site in Finland.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- COPD
- What is being tested?
- HFNC Airvo
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 3 participants
- Where
- 1 siteFinland
- Study dates
- 21 Apr 2022to 30 Apr 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
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
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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Open-Label Prospective Study Comparing Long-Term Outcome With or Without High-flow Nasal Cannula AirvoTM in Patients With Stable Hypercapnic COPD
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.
Read the 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.
- Conditions
- COPD
- Being tested
- HFNC Airvo, Standard care
- 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.
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
Standard careOther
No HFNC treatment
| Study group | Role | What they receive |
|---|---|---|
| Airvo | Active comparator | Patients allocated to use Airvo device Receives: Device: HFNC Airvo |
| Control | Placebo comparator | Patients not using Airvo, standard care Receives: Other: Standard care |
What is being measured
The primary outcome is the main question the study is designed to answer.
pCO2
Improvement in daytime capillary pCO2 ≥ 0.5 kPa in the AirvoTM group compared to the standard care group
Measured: 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
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Apr 2021
- Study start21 Apr 2022
- Primary completion30 Apr 2024
- Study completion30 Apr 2024
Why it stopped: It was not possible to achieve recruitment target
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for COPDStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 3 participants (actual)
Sponsor and investigators
- Lead sponsor
- Turku University Hospital
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Tarja Saaresranta, Turku University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04840706
- Sponsor's protocol ID
- MyAirvo
- Acronym
- MyAirvo
- Status last verified
- Dec 2025
- First submitted
- 9 Apr 2021
- Last updated
- 29 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Open-Label Prospective Study Comparing Long-Term Outcome With or Without High-flow Nasal Cannula AirvoTM in Patients With Stable Hypercapnic COPD
- ClinicalTrials.gov ID
- NCT04840706
- Acronym / sponsor ID
- MyAirvo / MyAirvo
- Conditions
- COPD
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: It was not possible to achieve recruitment target
- Enrolment
- 3 participants (actual)
- Lead sponsor
- Turku University HospitalOther government
- Study start
- 21 Apr 2022 (actual)
- Primary completion
- 30 Apr 2024 (actual)
- Study completion
- 30 Apr 2024 (actual)
- First posted
- 12 Apr 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Airvo | Active comparator | Device: HFNC AirvoPatients allocated to use Airvo device |
| Control | Placebo comparator | Other: Standard carePatients not using Airvo, standard care |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
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 |
|---|---|---|
| HFNC AirvoHFNC device (Airvo) long-term use in in stabile hypercapnic COPD patients, who are non-compliant to NIV after an acute exacerbation of COPD | Device | Airvo |
| Standard careNo HFNC treatment | Other | Control |
Primary outcome
pCO2
Time frame: 1 year
Improvement in daytime capillary pCO2 ≥ 0.5 kPa in the AirvoTM group compared to the standard care group
Acute exacerbation rate
Time frame: 1 year
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
Results and safety
The study was stopped early (reason given: It was not possible to achieve recruitment target). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Dec 2025.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing HFNC Airvo in people with COPD, run by Turku University Hospital at 1 site in Finland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
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 29 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Finland. 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. Some participants in this study may receive a placebo. 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?
The study was stopped early (reason given: It was not possible to achieve recruitment target). Results are not available in the source record.
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?
pCO2 (time frame: 1 year). The study lists 2 primary outcomes in all. 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 29 Dec 2025.