COPDNCT07222410
Closed Loop Oxygen Control in Chronic Obstructive Pulmonary Disease (COPD) Patients Treated With Nasal High Flow in the Hospital
A study testing Manual titration in people with COPD, run by Fisher and Paykel Healthcare at 4 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 22 years and older
- Conditions the study is for
- COPD
- What is being tested?
- Manual titration
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- 4 sitesUnited States
- Study dates
- 7 Jan 2026to Nov 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 22 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Has cognitive ability to provide informed consent
- Aged 22 years or older
- Hospitalized with hypoxemia/respiratory distress
- Diagnosis of COPD
- 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)
Who cannot join
- 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 informed consent
Show all 10Show fewer
- 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
Trial locations and contacts
4 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States4 sites, 4 recruiting
- Recruiting
The University of Alabama at Birmingham
Birmingham, Alabama, 35294
Raymond C Wade, 205-934-2490, rcwade@uab.edu
- Recruiting
Central Iowa Hospital Corp - UnityPoint Health
Des Moines, Iowa, 50309
Matthew Trump, 515-205-4013, mtrump@iowaclinic.com
- Recruiting
Icahn School of Medicine at Mount Sinai
New York, New York, 10029
Kathryn Dubowski, 212-420-2377, Kathryn.Dubowski@mountsinai.org
- Recruiting
Temple University Hospital
Philadelphia, Pennsylvania, 19140
Gerard Criner, 215-707-8113, Gerard.Criner@tuhs.temple.edu
About this study
Official title: Closed Loop Oxygen Control in COPD Patients Treated With Nasal High Flow in the Hospital
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.
- Conditions
- COPD
- Being tested
- Closed loop oxygen control, Manual titration
- Keywords
- COPD, closed loop oxygen control, hypoxemia, nasal high flow
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive, Hypoxia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Closed loop oxygen controlDevice
Nasal high flow with closed loop oxygen control
Manual titrationDevice
Nasal high flow with manual titration
| Study group | Role | What they receive |
|---|---|---|
| Airvo 3 (with OptiO2) OptiO2 mode on | Experimental | Not described Receives: Device: Closed loop oxygen control |
| Airvo 3 (with OptiO2) OptiO2 mode off | Active comparator | Not described Receives: Device: Manual titration |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of time with SpO2 in target range over period of observation
Measured: 24 hours
Percentage of time with SpO2 out of target range over period of observation
Measured: 24 hours
Secondary outcomes (3)
Count of number of adjustments in FiO2 by clinical staff over observation period
Measured: 24 hours
Percentage of time with SpO2 above target range over period of observation
Measured: 24 hours
Percentage of time with SpO2 below target range over period of observation
Measured: 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Oct 2025
- Study start7 Jan 2026
- Primary completionNov 2027 (estimated)
- Study completionNov 2027 (estimated)
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
- 70 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fisher and Paykel Healthcare
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07222410
- Sponsor's protocol ID
- CIA-334
- Status last verified
- Oct 2025
- First submitted
- 23 Oct 2025
- Last updated
- 23 Jun 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No: Sensitivity of data, data will be used for FDA submission
Study at a glance
From the registry record, last updated by the sponsor on 23 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Closed Loop Oxygen Control in COPD Patients Treated With Nasal High Flow in the Hospital
- ClinicalTrials.gov ID
- NCT07222410
- Acronym / sponsor ID
- CIA-334
- Conditions
- COPD
- Keywords
- COPD, closed loop oxygen control, hypoxemia, nasal high flow
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 70 participants (estimated)
- Lead sponsor
- Fisher and Paykel HealthcareIndustry (pharma, biotech, devices)
- Study start
- 7 Jan 2026 (actual)
- Primary completion
- Nov 2027 (estimated)
- Study completion
- Nov 2027 (estimated)
- First posted
- 29 Oct 2025 (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 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Airvo 3 (with OptiO2) OptiO2 mode on | Experimental | Device: Closed loop oxygen control |
| Airvo 3 (with OptiO2) OptiO2 mode off | Active comparator | Device: Manual titration |
Who may qualify
- Ages
- 22 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Has cognitive ability to provide informed consent
- Aged 22 years or older
- Hospitalized with hypoxemia/respiratory distress
- Diagnosis of COPD
- Candidate for/currently prescribed nasal high flow (flow rate of at least 25 L/min) with supplemental oxygen, as assessed by the investigator
Key exclusion criteria (10 listed)
- 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
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 |
|---|---|---|
| Closed loop oxygen controlNasal high flow with closed loop oxygen control | Device | Airvo 3 (with OptiO2) OptiO2 mode on |
| Manual titrationNasal high flow with manual titration | Device | Airvo 3 (with OptiO2) OptiO2 mode off |
Primary outcome
Percentage of time with SpO2 in target range over period of observation
Time frame: 24 hours
Percentage of time with SpO2 out of target range over period of observation
Time frame: 24 hours
3 secondary outcomes
Count of number of adjustments in FiO2 by clinical staff over observation period
Time frame: 24 hours
Percentage of time with SpO2 above target range over period of observation
Time frame: 24 hours
Percentage of time with SpO2 below target range over period of observation
Time frame: 24 hours
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jun 2026.
- Individual participant dataSharing planned: No. Sensitivity of data, data will be used for FDA submission
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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.
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Manual titration in people with COPD, run by Fisher and Paykel Healthcare at 4 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 10 exclusion criteria. 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: looking for participants now, as of the sponsor's last update on 23 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in United States. 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. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jenny Han (64 9 574 0123, optio2trial@fphcare.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of time with SpO2 in target range over period of observation (time frame: 24 hours). 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 23 Jun 2026.