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myAirvo 3 (High Flow Nasal Therapy; HFNT) for COPD patients in the home 鈥� a multi-center randomized controlled trial

  • Status
    Accepting Candidates
  • Age
    30 Years - NA Years
  • Sexes
    All
  • Healthy Volunteers
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Description

The purpose of this research is to learn if home use of high flow nasal therapy (HFNT) increases the time to rehospitalization in patients with chronic obstructive pulmonary disease (COPD). You will be randomly assigned to one of two groups. One group will receive usual medical care for COPD.聽 The other group will receive usual medical care for COPD and use a high-flow nasal therapy device for a minimum of 8 hours daily.聽 You will have up to six clinic visits and monthly phone calls.聽 You will complete daily COPD symptom reports. Taking part in this research will last for at least 12 months and up to 24 months if you are among the first to enroll in the study.

Details

Protocol number 20216340

Eligibility

Inclusion

Male or female, aged 30 years or greater MRC 鈮� 2 or CAT 鈮� 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 FEV1/FVC of < 70% and an FEV1 of < 80% (GOLD stages II 鈥� 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.

COPD in a stable condition after hospitalization in accordance to study criteria Willing to adhere to the daily use of the myAirvo 3 regimen for at least eight hours each day preferably at night following being shown and using the device Willing to record symptoms, pulse oximetry, and heart rate on a daily basis Have a home environment suitable for myAirvo 3 use Agreement to adhere to Lifestyle Considerations study duration 鈥搑efraining from smoking while receiving supplemental oxygen or the myAirvo-3 device

Exclusion

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

聽 聽

Lead researcher

  • Mehdi S Mirsaeidi, MD, MPH
    Pulmonologist, Critical Care Medicine Physician
    Languages: Persian

Participate in a study

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  1. Step
    1

    Contact the research team

    Call or email the research team listed within the specific clinical trial or study to let them know that you're interested. A member of the research team, such as the researcher or study coordinator, will be available to tell you more about the study and to answer any questions or concerns you may have.

    Primary contact

  2. Step
    2

    Get screened to confirm eligibility

    You may be asked to take part in prescreening to make sure you are eligible for a study. The prescreening process ensures it is safe for you to participate. During the prescreening process, you will be asked some questions and you may also be asked to schedule tests or procedures to confirm your eligibility.

  3. Step
    3

    Provide your consent to participate

    If you are eligible and want to join the clinical trial or study, a member of the research team will ask for your consent to participate. To give consent, you will be asked to read and sign a consent form for the study. This consent form explains the study's purpose, procedures, risks, benefits and provides other important information, such as the study team's contact information.

  4. Step
    4

    Participate

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