Stopped: Philips placed the study on hold in August 2022 due to the awareness of a potential device functionality issue. Philips has shifted business priorities and has decided to cancel the trial.
This prospective observational multicenter registry study will include adults greater than 40 years old, diagnosed with chronic obstructive pulmonary disease, requiring home noninvasive ventilation as part of standard medical care. For the purposes of this study, chronic obstructive pulmonary disease is defined as chronic respiratory failure consisting of historical spirometry vales (FEV1 \<60% predicted and FEV1/VC \< 0.7) and chronic increased daytime carbon dioxide levels greater than 6.0 kPa or 45 mmHg. In addition, participants diagnosed with major organ system diseases or obstructive sleep apnea will be excluded. At least 100 men and women who consent and meet the inclusion/exclusion criteria will be asked to participate. The anticipated study duration will be 6 months. The study will involve an initial visit for the standard of care initiation of home noninvasive ventilation. At this time, potential participants will be screened for participation. If eligible once consented, medical history will be collected and baseline questionnaires related to their respiratory disease will be completed. The registry study will include 6 month of home use of the noninvasive ventilator using the BiPAP A40 EFL device. Study staff will reach out to participants on a monthly basis to review any issues, medication changes, unscheduled visits, and device data download. Additional phone calls and or visits may occur on an as needed basis if issues arise. The final visit will be an in facility visit. The primary endpoint will be the overall prevalence of Expiratory Flow Limitation (EFL) in ventilated hypercapnic COPD patients, as defined as the percentage participants exhibiting a DeltaXrs value greater than or equal to 2.8 during one or more nights of therapy.
Age range
40 Years – 85 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
Screening Expiratory flow limitation
Timeframe: Screening
Expiratory flow limitation post therapy
Timeframe: 6 months