COPD Trial, Recruiting NCT05204888 Sponsor: Temple University Condition: COPD
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COPD Trial, Recruiting

NCT05204888
Recruiting Not Applicable

Who may be able to join

AI generated eligibility summary. Written by an AI model from the official source data and checked on a sample basis. It can contain mistakes, so confirm anything important against the original source. How we use AI

Who might be able to join this trial:

  • People who are willing and able to sign and date a consent form agreeing to take part
  • People who are willing to follow all study procedures and are available for the full duration of the study
  • People aged 30 years or older (any gender)
  • People with breathing test results confirming a moderate-to-very-severe level of COPD (known as GOLD stages II–IV, Grade E); a breathing test done within the past 6 months may be accepted in place of a new one
  • People whose breathlessness or COPD symptoms score above a certain level on standard questionnaires (MRC score of 2 or higher, or CAT score of 10 or higher)
  • People who are current smokers, former smokers, or who have never smoked — though current smokers must not smoke while using the study device or any supplemental oxygen
  • People who were hospitalised for a serious COPD flare-up within the previous six weeks
  • People whose COPD has settled and stabilised after that hospitalisation, meaning they no longer need injected or drip medications, are using inhalers less frequently, have not needed oxygen for at least 24 hours (unless home oxygen was already in place), are able to move around safely and independently if they were able to before, can eat and sleep without severe breathlessness, and have home care and follow-up arrangements in place
  • People who are willing to use the study breathing device (myAirvo 3) for at least 8 hours each day, preferably overnight
  • People who are willing to record their daily symptoms, blood oxygen levels, and heart rate each day
  • Women of childbearing potential who have been using a highly effective form of contraception for at least one month before the screening visit and who agree to continue using one throughout the study (examples include tubal ligation, the contraceptive pill, patches, implants, injections, rings, or intrauterine devices)
  • People who are able to read and communicate in English
  • People whose home is suitable for using the study device
  • People who agree to follow the study's lifestyle guidelines, including not smoking while using the device or supplemental oxygen

Who may not be able to join:

  • People who currently use PAP therapy, CPAP, or non-invasive ventilation on an ongoing basis
  • People who score higher than 5 on the STOPBang questionnaire (a screening tool for sleep apnea), unless a sleep study done within the past 3 months shows no obstructive sleep apnea, or the person has or may have sleep apnea but declines to use a sleep apnea device and meets all other criteria (confirm with trial site)
  • People who are currently pregnant or breastfeeding
  • People who have taken part in another clinical trial or received an experimental treatment within the past 30 days
  • People whose life expectancy is less than 12 months due to COPD or another serious health condition
  • People who have had upper airway surgery within the past month
  • People who have had a head or neck injury within the past month
  • People who are unable to tolerate wearing nasal prongs (the small tubes that sit at the entrance to the nostrils)
  • People who require oxygen delivered at a rate greater than 15 litres per minute

Important: Always verify eligibility with the trial site directly before applying.

Based on publicly available eligibility criteria from ClinicalTrials.gov. Verify directly with the trial site before acting. This is not medical advice.

This is a simplified plain English summary of the eligibility criteria. Full criteria are set by the trial investigators and may include additional requirements not shown here. Never self-exclude from a trial based on this summary. Contact the trial site directly to confirm your eligibility.
Last synced 12 July 2026
This study is not part of the standard drug-approval phase pathway (for example an observational, device, behavioural, or registry study), so a phase success rate does not apply.

Contact this trial

Phone: 215-707-8113

Contact details sourced from ClinicalTrials.gov. Verify directly with the trial site before attending.

GP referral letter

Print a one-page summary to share with your doctor.

Trial details

Status
Recruiting
Phase
Not Applicable
Sponsor
Temple University
Registry
ClinicalTrials.gov
Start date
2 February 2022
Est. completion
1 January 2027

Where this trial is recruiting

🇨🇦 Canada 🇺🇸 United States

Primary endpoints

To determine if myAirvo 3 use increases the time to first moderate exacerbation/severe exacerbation (hospitalization)/all-cause mortality in patients with moderate to very severe COPD.

Can't join this trial?

Expanded access pathways

If this trial is not available to you, other access pathways may exist. In Australia, the TGA Special Access Scheme allows access to unapproved therapeutic goods for individual patients.

TGA Special Access Scheme information

Find other recruiting trials on ClinicalTrials.gov

Data last synced from ClinicalTrials.gov: 12 July 2026. Trial status can change. Always verify current status directly with the trial site before making any decision.

Trial recruitment status can change without notice between our nightly data updates. Always contact the trial site directly to confirm current recruitment status before making any decisions or travel arrangements.

View original record on ClinicalTrials.gov