BridgeMD
New treatment option for COPD
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
- 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.
- 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
- To be eligible to participate in this study, an individual must meet all the following 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)
You likely can't join if
- An individual who meets any of the following criteria will be excluded from participation in this study:
- Current self-reported chronic use of positive airway pressure (PAP) therapy; continuous positive airway pressure (CPAP), or non-invasive positive...
- 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.
See the full eligibility criteria
- To be eligible to participate in this study, an individual must meet all the following 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
- COPD in a stable state after hospitalization defined as:
- 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
- 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 Highly effective contraception is...
- A tubal ligation:
- 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
- An individual who meets any of the following criteria will be excluded from participation in this study:
- 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's taking place
- 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 - 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?
Study sites include 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 location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.