COPD study: MyAirvo3 vs Pulse oximeter
Official title myAirvo 3 (High Flow Nasal Therapy; HFNT) for COPD Patients in the Home
ClinicalTrials.gov ID: NCT05204888
What this study is testing
- What it's testing
- This study is testing whether adding high flow nasal therapy at home helps people with severe COPD.
- Who it's for
- You may be able to join if you have GOLD Grade D COPD, stages II‑IV, and were hospitalized for a severe flare in the past 6 weeks.
- What's involved
- You would use the myAirvo 3 device at home along with your usual COPD medicines. You will have regular check‑ins for up to two years.
- Time commitment
- The study lasts up to two years with visits every few months.
Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 30 and older
You may be able to join if
- Provision of signed and dated informed consent form
- Stated willingness to comply with all study procedures and availability for the duration of the study
- Male or female, aged 30 years or greater
- FEV1/FVC of \< 70% and an FEV1 of \< 80% (GOLD stages II - IV, Grade E)
- Spirometry performed during the screening visit will be used to confirm GOLD stage.
You likely can't join if
- Current self-reported chronic use of positive airway pressure (PAP) therapy
- A STOPBang Questionnaire score \> 5\
- Pregnancy or lactation
- Treatment with another investigational drug or other intervention within the previous 30 days
- Life expectancy less than 12 months due to COPD or other comorbid condition.
- Recent upper airway surgery (within the previous month)
See the full eligibility criteria
- Provision of signed and dated informed consent form
- Stated willingness to comply with all study procedures and availability for the duration of the study
- Male or female, aged 30 years or greater
- FEV1/FVC of \< 70% and an FEV1 of \< 80% (GOLD stages II - IV, Grade E)
- Spirometry performed during the screening visit will be used to confirm GOLD stage. A prior spirometric test within the past 6 months can be substituted if available.
- MRC ≥ 2 or CAT ≥ 10
- Former smokers or current smokers and never-smokers are eligible for study inclusion
- Current smokers must refrain from smoking when using supplemental oxygen or the myAirvo-3 device
- History of a severe COPD exacerbation requiring hospitalization in the previous six weeks
- Clinically stable condition and have had no parenteral therapy for 24 hours.
- Inhaled bronchodilators are required less than four-hourly.
- Oxygen delivery has ceased for 24 hours (unless home oxygen is indicated).
- If previously able, the patient is ambulating safely and independently, and performing activities of daily living.
- The patient can eat and sleep without significant episodes of dyspnea.
- The patient or caregiver understands and can administer medications.
- Follow-up and home care arrangements (e.g., home oxygen, homecare, Meals on Wheels, community nurse, allied health, GP, specialist) have been completed.
- Willing to adhere to the daily use of the myAirvo 3 regimen for at least 8 hours each day preferably at night following being shown and using the device
- Willing to record daily symptoms and pulse oximetry and heart rate on daily basis
- An approved hormonal contraceptive such as oral contraceptives, emergency contraception used as directed, patches, implants, injections, rings or intrauterine devices
- Able to read and communicate in English
- Have a home environment suitable for myAirvo 3 use.
- Agreement to adhere to Lifestyle Considerations (see section 5.3) throughout study duration - refraining from smoking while receiving supplemental oxygen or the myAirvo-3 device
- Current self-reported chronic use of positive airway pressure (PAP) therapy; continuous positive airway pressure (CPAP), or non-invasive positive pressure ventilation (NPPV)
- A STOPBang Questionnaire score \> 5\
- Pregnancy or lactation
- Treatment with another investigational drug or other intervention within the previous 30 days
- Life expectancy less than 12 months due to COPD or other comorbid condition.
- Recent upper airway surgery (within the previous month)
- Recent head or neck trauma (within the previous month)
- Inability to tolerate nasal prongs
- Requirement of oxygen greater than 15 L/min
- people with a STOPBang questionnaire score of \> 5 may be eligible if a recent sleep study (within the previous 3 months) shows the absence of obstructive sleep apnea or the subject has, or is at risk of OSA, but...
The study team makes the final eligibility decision.
Where it is enrolling
- Birmingham, Alabama, United States
- Scottsdale, Arizona, United States
- Jacksonville, Florida, United States
- Kissimmee, Florida, United States
- Miami, Florida, United States
- Palmetto Bay, Florida, United States
- Chicago, Illinois, United States
- West Des Moines, Iowa, United States
- Baltimore, Maryland, United States
- Boston, Massachusetts, United States
- Burlington, Massachusetts, United States
- Detroit, Michigan, United States
- Minneapolis, Minnesota, United States
- Cincinnati, Ohio, United States
- Cleveland, Ohio, United States
- Columbus, Ohio, United States
- Bethlehem, Pennsylvania, United States
- DuBois, Pennsylvania, United States
- Philadelphia, Pennsylvania, United States
- Pittsburgh, Pennsylvania, United States
+ 5 more site(s).
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part, but confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 30 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
This study is enrolling now at Birmingham, Alabama, United States; Scottsdale, Arizona, United States; Jacksonville, Florida, United States; Kissimmee, Florida, United States; Miami, Florida, United States; Palmetto Bay, Florida, United States and 19 more locations. Enter your location above to see the nearest enrolling site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool that is independent of the study sponsor. Details come from ClinicalTrials.gov. The study team decides eligibility, and your own doctor gives medical advice.