NCT04452851Not yet recruiting
Portable Positive Pressure Therapy Device
Portable Non-invasive Positive Pressure Airway Device Therapy System Efficacy Study
Source: ClinicalTrials.gov · Last updated 25 Mar 2025 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
This study will assess the impact the BREATHE device provides on post-exertion recovery time in COPD patients when used during and/or after performing an Activity of Daily Living simulation. It will also establish equivalency with BiPAP machines.
- Status (registry)
- Not yet recruiting
- Study type
- Interventional
- Enrollment
- 20 (estimated)
- First submitted
- 24 Jun 2020
- Start date
- 1 Dec 2026
- Primary completion date
- 1 Aug 2027
- Lead sponsor
- Koronis Biomedical Technologies
- Diseases
- COPD
- NCT number
- NCT04452851
What you commit to
- Study type: Interventional
- Planned participants: 20
- From 1 Dec 2026 to the primary completion date, 1 Aug 2027
- No sites listed in no country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- Has physical impairment that prevents the subject from being able to walk or stand
Other
- Subject is not fluent in written or spoken English
- Is acutely ill/medically complicated, as determined by the investigator.
Who the study is looking for
- Subject is age 21 to 85
- Clinically stable
- Diagnosis of COPD following ERS-ATS guidelines 2011 update with GOLD criteria stage 3 ("Severe"), 30% ≤ FEV1 \< 50%
- Capable of giving informed consent
- Willing and able to comply with the test program as directed by staff.
Age in the registry: 21 years to 85 years · Sex: All · Does not accept healthy volunteers
This page is information, not medical advice. Discuss any trial with your doctor.