Digital inhaler management and breathing exercises for severe COPD

Plain-English translation of NCT06958666 on ClinicalTrials.gov ↗ ·

What is this trial?

This trial is testing two treatments — digital inhaler management (a smartphone-connected device that reminds you to use your inhaler and gives you feedback) and inspiratory muscle training (exercises to strengthen your breathing muscles) — to see if they can help people with severe COPD have fewer dangerous flare-ups and stay out of the hospital. You'll be in one of four groups: one getting the digital device alone, one doing breathing exercises alone, one getting both treatments, or one getting standard care only.

People with severe COPD often have flare-ups that land them in the hospital, and their symptoms can make daily life very difficult. This study wants to find out whether better inhaler use (with digital help) and stronger breathing muscles can prevent these serious flare-ups and improve quality of life.

Do you qualify?

You likely qualify if…

you have been diagnosed with COPD according to current medical guidelines
you are 40 years or older
you have moderate to severe airflow limitation in your lungs (FEV1/FVC < 60%)
you have significant COPD symptoms (a CAT score of 10 or higher, or difficulty with physical activity) or you've had at least 2 moderate flare-ups or 1 hospitalization in the past year
you are currently taking one of these maintenance medications: Breztri Aerosphere, Trelegy Ellipta, or Anoro Ellipta

You likely don't qualify if…

you have unstable heart disease or severe irregular heartbeats
you have severe weakness or fatigue from heart failure or recent cancer treatment
you have untreated mental illness or thoughts of harming yourself or others
you have severe memory problems or a progressive nerve disease that affects muscles
you are pregnant or breastfeeding

What participation looks like

You'll attend study visits at the start, then at 3 months, 6 months, and 12 months. Depending on which group you're in, you may receive training on using a digital inhaler device with a smartphone app that sends you reminders, practice breathing exercises using special equipment, or receive standard inhaler technique training. You'll complete questionnaires about your symptoms and quality of life, and have lung function tests to measure how well your lungs are working.

Digital inhaler management and breathing exercises for severe COPD

What is this trial?

Do you qualify?

What participation looks like

Trial locations(9 sites)