High Flow Nasal Therapy for COPD

Recruiting at 30 trial locations

Overseen By Gerard J Criner

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Temple University

Disqualifiers: Pregnancy, CPAP use, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 1 Jurisdiction This treatment is already approved in other countries

Compensation: Varies

Number of Visits: Unknown

Duration: 1-2 years

642 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

Parallel-group, prospective, randomized, controlled phase III trial of home High flow Nasal Therapy (HFNT) via myAirvo 3 plus usual COPD medical care vs. usual COPD medical care, for at least 1 year and up to two years in 642 GOLD Grade D, Stages II-IV patients with moderate to very severe COPD at risk for moderate and severe exacerbations with a prior history of severe exacerbation requiring hospitalization within the past 6 weeks.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications. It seems you can continue your usual COPD medical care while participating.

How is the treatment myAirvo3 different from other treatments for COPD?

The myAirvo3 treatment, also known as High Flow Nasal Therapy (HFNT), is unique because it delivers a high flow of oxygen through a nasal cannula, which can be more comfortable and effective than traditional oxygen therapy. It helps improve breathing by providing humidified and heated air, which can be particularly beneficial for patients with COPD who experience difficulty in breathing. ^{1 2 3 4 5}

What data supports the effectiveness of the treatment High Flow Nasal Therapy for COPD?

Research shows that High Flow Nasal Therapy (HFNT) can improve breathing in COPD patients by helping clear mucus, reducing dead space in the nose and throat, and improving oxygen and carbon dioxide exchange. It is also found to be safe and well-tolerated in patients with COPD exacerbations. ^{3 5 6 7 8}

Are You a Good Fit for This Trial?

This trial is for COPD patients aged 40+, who've had a severe exacerbation requiring hospitalization in the past 6 weeks. They must be able to use myAirvo 3 at home, record daily symptoms, and commit to the study's duration. Smokers with a ≥10 pack-year history can join if they meet specific lung function criteria (GOLD stages II-IV). Exclusions include certain sleep apnea scores, recent investigational drug use, life expectancy under 12 months due to other conditions, oxygen needs over 15 L/min, or inability to tolerate nasal prongs.

Inclusion Criteria

For females of reproductive potential: use of highly effective contraception for at least 1 month prior to screening and agreement to use such a method during study participation

My breathing difficulty is moderate to severe.

I was hospitalized for a severe COPD flare-up in the last six weeks.

Exclusion Criteria

I have not had a head or neck injury in the last month.

Requirement of oxygen greater than 15 L/min

A STOPBang Questionnaire score > 5

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive home High Flow Nasal Therapy (HFNT) via myAirvo 3 plus usual COPD medical care

1-2 years

Regular monitoring visits

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• myAirvo3
• Pulse oximeter

Trial Overview The trial tests if High Flow Nasal Therapy (HFNT) using myAirvo 3 plus usual medical care improves outcomes for COPD patients compared to usual care alone. It's a phase III study where participants are randomly assigned into two groups: one receiving HFNT at home and the other not. The treatment lasts between one and two years.

How Is the Trial Designed?

Group I: Usual COPD care Active Control 1 Intervention

The intervention : A pulse oximeter to record heart rate and pulse oximetry on a daily basis will be provided. A smart phone and charger will also be provided to answer a short questionnaire that queries daily respiratory symptoms plus enter heart rate and pulse oximetry data

Group II: Usual COPD care with use of the myAirvo 3 integrated humidifier and flow generator. Active Control 1 Intervention

The intervention is the myAirvo 3 humidifier with integrated flow generator delivered through the Optiflow™ + Duet nasal cannula.

myAirvo3 is already approved in United States for the following indications:

Approved in United States as myAirvo 3 for:

• Chronic Obstructive Pulmonary Disease (COPD)

Who Is Running the Clinical Trial?

Temple University

Lead Sponsor

Trials

321

Recruited

89,100+

Fisher and Paykel Healthcare

Industry Sponsor

Trials

127

Recruited

11,000+

Dr. Justin Vaughan

Fisher and Paykel Healthcare

Chief Medical Officer since 2024

MD from the University of Auckland

Lewis Gradon

Fisher and Paykel Healthcare

Chief Executive Officer since 2016

Bachelor of Science in Physics from the University of Auckland, New Zealand

Fisher & Paykel Healthcare

Collaborator

Trials

1

Recruited

640+

Published Research Related to This Trial

High-flow nasal oxygen therapy (HFNOT) was successfully used in 6 children undergoing 14 endoscopic procedures for upper airway obstruction, demonstrating its effectiveness in this setting.

No intraoperative complications related to oxygenation were observed, indicating that HFNOT is a safe technique for pediatric airway surgery.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Early experience with high-flow nasal oxygen therapy (HFNOT) in pediatric endoscopic airway surgery. Riva, T., Theiler, L., Jaquet, Y., et al.[2018]

In a pilot study involving 10 patients with hypercapnic COPD exacerbations, high-flow nasal therapy (HFNT) was found to be safe and well tolerated, with no increase in carbon dioxide levels or worsening of dyspnea during treatment.

All participants successfully used HFNT for at least 3 days without requiring additional interventions like non-invasive ventilation or intubation, indicating its potential as a supportive therapy in managing COPD exacerbations.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Tolerability and Safety of High-Flow Nasal Therapy in Patients Hospitalized with an Exacerbation of COPD. Pandya, AA., Criner, LH., Thomas, J., et al.[2023]

Transnasal high-flow oxygen therapy (HFNT) was found to be more effective than noninvasive positive pressure ventilation (NIV) in improving oxygen levels and carbon dioxide levels in patients with chronic obstructive pulmonary disease (COPD) and type II respiratory failure, based on a meta-analysis of 12 randomized controlled trials involving 948 patients.

HFNT also demonstrated better comfort and tolerance compared to NIV, without increasing the treatment failure rate, suggesting it could be a promising alternative for respiratory support in these patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Transnasal High-Flow Oxygen Therapy versus Noninvasive Positive Pressure Ventilation in the Treatment of COPD with Type II Respiratory Failure: A Meta-Analysis. Liu, W., Zhu, M., Xia, L., et al.[2023]

High-flow nasal cannula (HFNC) therapy significantly reduced carbon dioxide levels (PaCO2) and treatment failure rates in patients with acute hypercapnic COPD compared to conventional oxygen therapy (COT), indicating its efficacy in managing acute respiratory distress.

In patients with chronic hypercapnic COPD, HFNC may help lower the rates of exacerbations, although it did not show significant improvements in oxygen levels (PaO2) or carbon dioxide levels (PaCO2), suggesting its potential benefits in long-term management.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Comparison of High-Flow Nasal Cannula with Conventional Oxygen Therapy in Patients with Hypercapnic Chronic Obstructive Pulmonary Disease: A Systematic Review and Meta-Analysis. Zhang, L., Wang, Y., Ye, Y., et al.[2023]

High-flow nasal therapy (HFNT) delivers humidified, heated oxygen-enriched air, which has been shown to improve mucociliary clearance and enhance gas exchange in patients with chronic obstructive pulmonary disease (COPD).

Recent studies indicate that HFNT can effectively reduce CO2 levels and improve lung function in stable COPD patients, highlighting its potential as a beneficial treatment option.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Mechanisms of Benefit of High-Flow Nasal Therapy in Stable COPD. Zantah, M., Pandya, A., Jacobs, MR., et al.[2020]

In a study of 51 patients with severe community-acquired pneumonia, high-flow nasal oxygen therapy (HFNOT) was found to be effective for both hypoxemic (Type I) and hypercapnic (Type II) respiratory failure, with a successful outcome in 78% of Type I patients and 58% of Type II patients.

No patients in the study experienced mortality, indicating that HFNOT is a safe intervention, but caution is advised in identifying patients who may require further escalation of care.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effectiveness of high-flow nasal oxygen therapy in management of acute hypoxemic and hypercapnic respiratory failure. Norkienė, I., d'Espiney, R., Martin-Lazaro, JF.[2022]

High-flow nasal cannula (HFNC) therapy significantly improved dyspnea, breathing frequency, and oxygen saturation in 90 out of 111 patients treated outside the ICU, indicating its efficacy in non-ICU settings.

Despite the benefits observed, the study reported a high overall mortality rate of 50%, suggesting that HFNC may often be used in a palliative context, particularly among patients with do not resuscitate (DNR) orders.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Use of High-Flow Nasal Cannula Oxygen Outside the ICU. Zemach, S., Helviz, Y., Shitrit, M., et al.[2020]

High-flow nasal cannula oxygen therapy (HFOT) is recommended over noninvasive ventilation (NIV) for patients with de novo acute respiratory failure, as NIV may worsen lung injury due to high tidal volumes.

NIV remains the preferred option for postoperative patients and those with acute hypercapnic respiratory failure, while HFOT could serve as an alternative in managing acute respiratory failure in postoperative cardiothoracic patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Noninvasive ventilation versus oxygen therapy in patients with acute respiratory failure. Frat, JP., Joly, F., Thille, AW.[2020]

Citations

1. Ireland pubmed.ncbi.nlm.nih.gov

Early experience with high-flow nasal oxygen therapy (HFNOT) in pediatric endoscopic airway surgery. [2018]

2. United States pubmed.ncbi.nlm.nih.gov

Tolerability and Safety of High-Flow Nasal Therapy in Patients Hospitalized with an Exacerbation of COPD. [2023]

3. United States pubmed.ncbi.nlm.nih.gov

Transnasal High-Flow Oxygen Therapy versus Noninvasive Positive Pressure Ventilation in the Treatment of COPD with Type II Respiratory Failure: A Meta-Analysis. [2023]

4. New Zealand pubmed.ncbi.nlm.nih.gov

Comparison of High-Flow Nasal Cannula with Conventional Oxygen Therapy in Patients with Hypercapnic Chronic Obstructive Pulmonary Disease: A Systematic Review and Meta-Analysis. [2023]

5. Switzerland pubmed.ncbi.nlm.nih.gov

The Mechanisms of Benefit of High-Flow Nasal Therapy in Stable COPD. [2020]

6. Lithuania pubmed.ncbi.nlm.nih.gov

Effectiveness of high-flow nasal oxygen therapy in management of acute hypoxemic and hypercapnic respiratory failure. [2022]

7. United States pubmed.ncbi.nlm.nih.gov

The Use of High-Flow Nasal Cannula Oxygen Outside the ICU. [2020]

8. United States pubmed.ncbi.nlm.nih.gov

Noninvasive ventilation versus oxygen therapy in patients with acute respiratory failure. [2020]