High-Flow Air + Oxygen Therapy for Lung Disease

No longer recruiting at 1 trial location

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Johns Hopkins University

Disqualifiers: Pregnancy, Unstable angina, others

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

Compensation: Varies

Number of Visits: 2

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests different methods of providing oxygen therapy to individuals with specific lung diseases, such as COPD, ILD, or Pulmonary Hypertension. The goal is to determine if adding high-flow air to oxygen therapy (nasal delivery of high-flow air and oxygen therapy) helps maintain a healthy oxygen level more effectively than oxygen alone. Participants will try various combinations of oxygen and high-flow air delivered nasally while resting. Suitable candidates have a diagnosis of one of these lung diseases and require oxygen therapy at rest. As an unphased trial, this study offers a unique opportunity to explore innovative oxygen therapy methods that could enhance quality of life.

Will I have to stop taking my current medications?

The trial information does not specify if you need to stop taking your current medications. However, it does mention that you cannot participate if you've been treated with another investigational drug or intervention within the last three months.

What prior data suggests that this method is safe for lung disease patients?

Research has shown that high-flow nasal cannula (HFNC) therapy is safe and well-tolerated for individuals with various breathing problems. One study found that HFNC is effective and safe for those with chronic obstructive pulmonary disease (COPD), regardless of whether their carbon dioxide levels are normal or elevated. Another study confirmed that HFNC is commonly used to treat severe respiratory issues in critically ill patients and is generally well-tolerated. Although the details of this new trial are not provided, existing research suggests that high-flow air and oxygen therapy is safe for individuals. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the High-Flow Air + Oxygen Therapy for lung disease because it offers a novel delivery method that combines high-flow air with oxygen, potentially providing faster and more effective relief for patients. Unlike traditional oxygen therapy, which typically uses a constant flow of low oxygen levels, this approach uses high-flow rates and pulsed delivery, enhancing oxygen uptake and reducing work for the lungs. This method could lead to improved breathing comfort and better overall lung function, making it a promising alternative to standard oxygen therapy.

What evidence suggests that this trial's treatments could be effective for lung disease?

Research has shown that high-flow nasal cannula (HFNC) oxygen therapy can aid in managing lung conditions such as COPD, ILD, and PH. Studies indicate that HFNC stabilizes vital signs and improves breathing in individuals with respiratory issues. For those with COPD, it lowers breathing rates and reduces carbon dioxide levels in the blood while enhancing lung function. Additionally, research suggests it may extend the lives of people with severe breathing problems. HFNC can also facilitate exercise and daily activities for those with lung diseases. Overall, these findings suggest that HFNC with oxygen effectively relieves low blood oxygen levels in patients with these conditions. This trial will evaluate different methods of delivering high-flow air and oxygen therapy to identify the most effective approach for improving patient outcomes. ^{1 6 7 8 9}

Who Is on the Research Team?

Sonye Danoff, MD, PhD

Principal Investigator

Johns Hopkins University

Are You a Good Fit for This Trial?

This trial is for adults aged 30 or older with certain lung diseases like COPD, ILD, or PH who need oxygen therapy at rest. They must have a history of stable heart rate and blood pressure, not be pregnant or breastfeeding, and haven't had recent cardiovascular issues.

Inclusion Criteria

My blood oxygen level is above 80% without extra oxygen.

You have had a pulmonary function test in the last three months.

I am 30 years old or older.

Exclusion Criteria

I have had recent heart or stroke issues.

Pregnancy or lactation

Treatment with another investigational drug or other intervention within three months

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Baseline Titration

Participants perform baseline titration with oxygen only to determine the required oxygen flow rate to maintain 95% SpO2.

Approximately 15 minutes

1 visit (in-person)

Intervention

Participants are titrated with six different delivery methods, including Out-of-Phase pulsed high-flow air and oxygen, and Continuous high-flow air with pulsed oxygen.

4-5 hours

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

1-2 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Nasal Delivery of High-Flow Air and Oxygen Therapy
• Nasal Delivery of Oxygen Therapy

Trial Overview The study compares standard oxygen therapy to two new methods: one combines high-flow air with oxygen, and the other alternates between them. The goal is to see which method best maintains an oxygen saturation level of 95% during rest.

How Is the Trial Designed?

Group I: Baseline followed by intervention 2f Experimental Treatment 2 Interventions

Subjects perform baseline titration with oxygen only first. Subjects are then titrated with six different delivery methods. The subjects will be first delivered Out-of-Phase pulsed high-flow air and oxygen (order of high-flow air flow rate: 25 L/min, 20 L/min, 15 L/min) and then Continuous high-flow air with pulsed oxygen (order of high-flow air flow rate: 25 L/min, 20 L/min, 15 L/min).

Group II: Baseline followed by intervention 2e Experimental Treatment 2 Interventions

Subjects perform baseline titration with oxygen only first. Subjects are then titrated with six different delivery methods. The subjects will be first delivered Out-of-Phase pulsed high-flow air and oxygen (order of high-flow air flow rate: 25 L/min, 15 L/min, 20 L/min) and then Continuous high-flow air with pulsed oxygen (order of high-flow air flow rate: 25 L/min, 15 L/min, 20 L/min).

Group III: Baseline followed by intervention 2d Experimental Treatment 2 Interventions

Subjects perform baseline titration with oxygen only first. Subjects are then titrated with six different delivery methods. The subjects will be first delivered Out-of-Phase pulsed high-flow air and oxygen (order of high-flow air flow rate: 20 L/min, 25 L/min, 15 L/min) and then Continuous high-flow air with pulsed oxygen (order of high-flow air flow rate: 20 L/min, 25 L/min, 15 L/min).

Group IV: Baseline followed by intervention 2c Experimental Treatment 2 Interventions

Subjects perform baseline titration with oxygen only first. Subjects are then titrated with six different delivery methods. The subjects will be first delivered Out-of-Phase pulsed high-flow air and oxygen order of high-flow air flow rate: 20 L/min, 15 L/min, 25 L/min) and then Continuous high-flow air with pulsed oxygen (order of high-flow air flow rate: 20 L/min, 15 L/min, 25 L/min).

Group V: Baseline followed by intervention 2b Experimental Treatment 2 Interventions

Subjects perform baseline titration with oxygen only first. Subjects are then titrated with six different delivery methods. The subjects will be first delivered Out-of-Phase pulsed high-flow air and oxygen (order of high-flow air flow rate: 15 L/min, 25 L/min, 20 L/min) and then Continuous high-flow air with pulsed oxygen (order of high-flow air flow rate: 15 L/min, 25 L/min, 20 L/min).

Group VI: Baseline followed by intervention 2a Experimental Treatment 2 Interventions

Subjects perform baseline titration with oxygen only first. Subjects are then titrated with six different delivery methods. The subjects will be first delivered Out-of-Phase pulsed high-flow air and oxygen (order of high-flow air flow rate: 15 L/min, 20 L/min, 25 L/min) and then Continuous high-flow air with pulsed oxygen (order of high-flow air flow rate: 15 L/min, 20 L/min, 25 L/min).

Group VII: Baseline followed by intervention 1f Experimental Treatment 2 Interventions

Subjects perform baseline titration with oxygen only first. Subjects are then titrated with six different delivery methods. The subjects will be first delivered Out-of-Phase pulsed high-flow air and oxygen (order of high-flow air flow rate: 25 L/min, 20 L/min, 15 L/min) and then Continuous high-flow air with pulsed oxygen (order of high-flow air flow rate: 25 L/min, 20 L/min, 15 L/min).

Group VIII: Baseline followed by intervention 1e Experimental Treatment 2 Interventions

Subjects perform baseline titration with oxygen only first. Subjects are then titrated with six different delivery methods. The subjects will be first delivered Out-of-Phase pulsed high-flow air and oxygen (order of high-flow air flow rate: 25 L/min, 15 L/min, 20 L/min) and then Continuous high-flow air with pulsed oxygen (order of high-flow air flow rate: 25 L/min, 15 L/min, 20 L/min).

Group IX: Baseline followed by intervention 1d Experimental Treatment 2 Interventions

Subjects perform baseline titration with oxygen only first. Subjects are then titrated with six different delivery methods. The subjects will be first delivered Continuous high-flow air with pulsed oxygen (order of high-flow air flow rate: 20 L/min, 25 L/min, 15 L/min) and then Out-of-Phase pulsed high-flow air and oxygen (order of high-flow air flow rate: 20 L/min, 25 L/min, 15 L/min).

Group X: Baseline followed by intervention 1c Experimental Treatment 2 Interventions

Subjects perform baseline titration with oxygen only first. Subjects are then titrated with six different delivery methods. The subjects will be first delivered Continuous high-flow air with pulsed oxygen (order of high-flow air flow rate: 20 L/min, 15 L/min, 25 L/min) and then Out-of-Phase pulsed high-flow air and oxygen (order of high-flow air flow rate: 20 L/min, 15 L/min, 25 L/min).

Group XI: Baseline followed by intervention 1b Experimental Treatment 2 Interventions

Subjects perform baseline titration with oxygen only first. Subjects are then titrated with six different delivery methods. The subjects will be first delivered Continuous high-flow air with pulsed oxygen (order of high-flow air flow rate: 15 L/min, 25 L/min, 20 L/min) and then Out-of-Phase pulsed high-flow air and oxygen (order of high-flow air flow rate: 15 L/min, 25 L/min, 20 L/min).

Group XII: Baseline followed by intervention 1a Experimental Treatment 2 Interventions

Subjects perform baseline titration with oxygen only first. Subjects are then titrated with six different delivery methods. The subjects will be first delivered Continuous high-flow air with pulsed oxygen (order of high-flow air flow rate: 15 L/min, 20 L/min, 25 L/min) and then Out-of-Phase pulsed high-flow air and oxygen (order of high-flow air flow rate: 15 L/min, 20 L/min, 25 L/min).

Who Is Running the Clinical Trial?

Johns Hopkins University

Lead Sponsor

Trials

2,366

Recruited

15,160,000+

American College of Chest Physicians

Collaborator

Trials

10

Recruited

2,200+

CHEST Foundation

Collaborator

Trials

4

Recruited

190+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC5864634/

Effectiveness of high-flow nasal cannula oxygen therapy ... This study revealed that HFNC oxygen therapy was beneficial even in the patients with acute hypercapnic respiratory failure. The vital signs were stabilized and ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11375959/

A Comprehensive Review on High-Flow Nasal Cannula ... Notably, in patients with COVID-19-related respiratory failure, HFNO has shown promising survival benefits, with some studies reporting survival ...

3. sciencedirect.com sciencedirect.com/science/article/pii/S2667100X24001233

Physiological effects and clinical evidence of high-flow ... Nasal high flow oxygen therapy in patients with COPD reduces respiratory rate and tissue carbon dioxide while increasing tidal and end-expiratory lung ...

4. journals.lww.com journals.lww.com/anesthesia-analgesia/fulltext/2025/11000/high_flow_nasal_oxygen_versus_mechanical.27.aspx

High-Flow Nasal Oxygen versus Mechanical Ventilation... ... Based on these data, we estimated a 95% success rate both for HFNO and laryngeal mask ventilation. For a unilateral 95% CI and a power of 90%, 82 was the ...

5. journalpulmonology.org journalpulmonology.org/pt-clinical-evidence-on-high-flow-articulo-S0873215913000391

Clinical evidence on high flow oxygen therapy and active ... This study shows that the use of high-flow oxygen via both transtracheal catheter and nasal prongs significantly increased exercise tolerance in COPD patients ...

6. accjournal.org accjournal.org/journal/view.php?doi=10.4266/acc.2021.01571

High-flow nasal cannula for respiratory failure in adult ... HFNC has been successfully used in critically ill patients with several conditions, such as hypoxemic respiratory failure, hypercapneic ...

7. archbronconeumol.org archbronconeumol.org/en-separ-position-paper-on-use-avance-S0300289625001462

SEPAR Position Paper on the Use of High Flow Nasal ... Efficacy and tolerability of high-flow nasal cannula oxygen therapy for hypoxemic respiratory failure in patients with interstitial lung disease ...

8. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0140673616302458

High-flow oxygen therapy and other inhaled ... In this Series paper, we review the current evidence for the use of high-flow oxygen therapy, inhaled gases, and aerosols in the care of critically ill ...

9. bmcpulmmed.biomedcentral.com bmcpulmmed.biomedcentral.com/articles/10.1186/s12890-017-0486-3

Efficacy and safety of nasal high-flow oxygen in COPD patients Summary. Short-term nasal highflow oxygen therapy (HFOT) is safe and efficacious in normocapnic and hypercapnic COPD patients.