Status:
NOT_YET_RECRUITING
Portable Positive Pressure Therapy Device
Lead Sponsor:
Koronis Biomedical Technologies
Conditions:
COPD
Eligibility:
All Genders
21-85 years
Phase:
NA
Brief Summary
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 a...
Detailed Description
Study Overview: Potential subjects who are clinically stable COPD patients with 30% ≤ FEV1 \< 50% (COPD GOLD criteria stage 3), will be enrolled. Following consent procedures, interested participants ...
Eligibility Criteria
Inclusion
- 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.
Exclusion
- Subject is not fluent in written or spoken English
- Has physical impairment that prevents the subject from being able to walk or stand
- Is acutely ill/medically complicated, as determined by the investigator.
Key Trial Info
Start Date :
December 1 2026
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
August 1 2027
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT04452851
Start Date
December 1 2026
End Date
August 1 2027
Last Update
March 25 2025
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