ClinicalTrials.gg
RecruitingNCT07222410Updated Jun 23, 2026

Closed Loop Oxygen Control in Chronic Obstructive Pulmonary Disease (COPD) Patients Treated With Nasal High Flow in the Hospital

An interventional study of Closed loop oxygen control and Manual titration in COPD, sponsored by Fisher and Paykel Healthcare. Recruiting at 4 sites in United States. Open to participants aged 22 Years and older. Per ClinicalTrials.gov, last updated 2026-06-23.

Sponsored by Fisher and Paykel Healthcare · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Started Jan 2026; still recruiting 10 months later.
Phase
Not applicable
Study type
Interventional
Enrollment
70
Allocation
Randomized
Ages
22 Years and older
Sex
All
01

Study summary

The trial aims to evaluate whether the Airvo 3 device in OptiO2 mode can maintain patients' SpO2 levels within the target range better than manual oxygen titration in hospitalized COPD patients with hypoxemia/respiratory distress.

02

Conditions studied

  • COPD

Keywords

  • COPD
  • closed loop oxygen control
  • hypoxemia
  • nasal high flow
03

In context

Pulmonary Disease, Chronic Obstructive

5,520 studies on the registry are indexed under Pulmonary Disease, Chronic Obstructive; 856 are open to participants now.

This study's planned enrollment of 70 is above the median of 62 across 3,839 interventional studies indexed under Pulmonary Disease, Chronic Obstructive.

Browse Pulmonary Disease, Chronic Obstructive studies →

Lead sponsor

Fisher and Paykel Healthcare is the lead sponsor of 86 studies on the registry; 16 are open to participants now.

Of its 11 completed or terminated interventional studies of FDA-regulated products, 10 (91%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
22 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Has cognitive ability to provide
  • Aged 22 years or older
  • Hospitalized with hypoxemia/respiratory distress
  • Diagnosis of
  • Candidate for/currently prescribed nasal high flow (flow rate of at least 25 L/min) with supplemental oxygen, as assessed by the investigator
  • Expected duration of oxygen and nasal high flow therapy >24 hours (not necessarily continuous)

Exclusion criteria

Exclusion Criteria:

  • Receiving Non Invasive Ventilation (NIV) or indicated for NIV as per European Respiratory Society /American Thoracic Society guidelines
  • Hemodynamic instability (systolic blood pressure \<90mmHg or requirement for vasopressor or inotropic support)
  • Patient receiving end of life care
  • Nasal or facial conditions precluding use of nasal high flow
  • Pregnancy or breastfeeding
  • Cognitive impairment or impaired consciousness precluding
  • Unsuitable for adhesive finger pulse oximetry, as assessed by the investigator
  • Any other condition which, at the investigator's discretion, is believed to present a safety risk to the patient if included
  • The presence of any active comorbidities that affect the patient's condition importantly in the next 30 days, as assessed by the investigator
  • Has already participated in this clinical trial
Terms in these criteria, in plain language(2)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

COPD

Chronic obstructive pulmonary disease: long-term lung disease that makes it hard to breathe out, including emphysema and chronic bronchitis.

05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
70 participants (estimated)

Study arms

  • Experimental
    Airvo 3 (with OptiO2) OptiO2 mode on

    Device: Closed loop oxygen control

  • Active comparator
    Airvo 3 (with OptiO2) OptiO2 mode off

    Device: Manual titration

Interventions

  • DeviceClosed loop oxygen control

    Nasal high flow with closed loop oxygen control

  • DeviceManual titration

    Nasal high flow with manual titration

06

What researchers measure

Primary outcomes

  1. Percentage of time with SpO2 in target range over period of observation

    Time frame: 24 hours

  2. Percentage of time with SpO2 out of target range over period of observation

    Time frame: 24 hours

Secondary outcomes

  1. Count of number of adjustments in FiO2 by clinical staff over observation period

    Time frame: 24 hours

  2. Percentage of time with SpO2 above target range over period of observation

    Time frame: 24 hours

  3. Percentage of time with SpO2 below target range over period of observation

    Time frame: 24 hours

07

Study locations

4 of 4 sites recruiting
08

References and documents

Individual participant data

Plan to share: No — Sensitivity of data, data will be used for FDA submission

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Started Jan 2026 (actual). Primary completion is estimated for Nov 2027, 22 months after the start.

Of 87 industry-sponsored interventional studies with no phase under Pulmonary Disease, Chronic Obstructive, half reached primary completion within 21 months of starting (the median), counting those still running; a quarter within 10 and three quarters within 35. This study's planned 22 months is close to that.

Counting every sponsor, half of 1,181 studies reached it within 22 months; a quarter within 10 and three quarters within 39.

How these figures are worked out, and which studies are left out of them.

Registered
Oct 23, 2025
First posted
Oct 29, 2025
StartActual
Jan 7, 2026
Primary completionEst.
Nov 2027
CompletionEst.
Nov 2027
Last update
Jun 23, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Jun 23, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07222410
Responsible party
Sponsor
First posted
Oct 29, 2025
Start date
Jan 7, 2026
Primary completion
Nov 2027 (estimated)
Completion
Nov 2027 (estimated)
Last update
Jun 23, 2026

Study contacts

Jenny Han
Contact
optio2trial@fphcare.com
64 9 574 0123

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
Yes
View the source record on ClinicalTrials.gov ↗

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