High Flow Nasal Therapy for COPD

Recruiting in Palo Alto (17 mi)

+30 other locations

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Recruiting

Sponsor: Temple University

Disqualifiers: Pregnancy, CPAP use, others

No Placebo Group

Approved in 1 Jurisdiction

Trial Summary

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.

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. ^{1 2 3 4 5}

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 4 6 7 8}

Research Team

Eligibility Criteria

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

Trial Timeline

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

Treatment Details

Interventions

• myAirvo3 (Device)
• Pulse oximeter (Device)

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.

Participant Groups

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)

Find a Clinic Near You

Research Locations Nearby Select from list below to view details:

Ohio State University Wexner Medical Center Columbus, OH

Destiny Research Palmetto Bay, FL

Heights Hospital Houston, TX

UAB School of Medicine/Lung Health Center Birmingham, AL

More Trial Locations

Who Is Running the Clinical Trial?

Temple University

Lead Sponsor

Trials

321

Patients Recruited

89,100+

Fisher and Paykel Healthcare

Industry Sponsor

Trials

127

Patients Recruited

11,000+

Fisher & Paykel Healthcare

Collaborator

Trials

1

Patients Recruited

640+

References

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

Early experience with high-flow nasal oxygen therapy (HFNOT) in pediatric endoscopic airway surgery. [2018] Reporting our institutional experience with high-flow nasal oxygen therapy (HFNOT), a recently-introduced technique, for endoscopic airway approaches.

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] The effect of high-flow nasal therapy (HFNT) in individuals with an exacerbation of chronic obstructive pulmonary disease (COPD) and hypercapnia is not well studied. We assessed patient tolerance and impact of air-gas therapy delivered by humidified HFNT (20-35 L/min) on gas exchange in hypercapnic COPD patients during hospitalization for COPD exacerbation. We hypothesized that HFNT use would be safe and well tolerated in individuals hospitalized for COPD exacerbation regardless of the degree of hypercapnia.

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] To compare the safety and efficacy of transnasal high-flow oxygen therapy (HFNT) and noninvasive positive pressure ventilation (NIV) in the treatment of chronic obstructive pulmonary disease (COPD) with type II respiratory failure.

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] Label="Purpose">This study aimed to evaluate the clinical outcomes of high-flow nasal cannula (HFNC) compared with conventional oxygen therapy (COT) in patients with hypercapnic chronic obstructive pulmonary disease (COPD), including arterial partial pressure of carbon dioxide (PaCO2), arterial partial pressure of oxygen (PaO2), respiratory rate (RR), treatment failure, exacerbation rates, adverse events and comfort evaluation.

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

The Mechanisms of Benefit of High-Flow Nasal Therapy in Stable COPD. [2020] High-flow nasal therapy (HFNT) is a unique system that delivers humidified, heated oxygen-enriched air via nasal cannula at high flow rates. It is a promising therapy for chronic obstructive pulmonary disease (COPD) patients. Several studies have examined the physiologic effects of this therapy in the patient population and have revealed that it improves mucociliary clearance, reduces nasopharyngeal dead space, and subsequently increases CO2 washout. It also improves alveolar recruitment and gas exchange. These mechanisms may explain the promising results observed in recently published studies that examined the role of HFNT in stable COPD patients.

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

Effectiveness of high-flow nasal oxygen therapy in management of acute hypoxemic and hypercapnic respiratory failure. [2022] High-flow nasal oxygen therapy (HFNOT) therapy has been increasingly used in patients with acute hypoxemic (Type I) respiratory failure (RF). Meanwhile indications and clinical effectiveness of HFNOT in patients with hypercapnic (Type II) RF remain controversial. The aim of our study was to evaluate the outcomes of primary HFTNOT in patients with hypoxemic and hypercapnic RF.

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

The Use of High-Flow Nasal Cannula Oxygen Outside the ICU. [2020] High-flow nasal cannula (HFNC) oxygen therapy is a routine, evidence-based treatment in the ICU. Due to its ease of application, non-evidence-based use of HFNC has spread to non-ICU wards. This study reports on the experience with HFNC outside the ICU.

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

Noninvasive ventilation versus oxygen therapy in patients with acute respiratory failure. [2020] High-flow nasal cannula oxygen therapy (HFOT) is becoming an alternative to noninvasive ventilation (NIV) and standard oxygen in management of patients with acute respiratory failure.