NCT05109754

Home Non-Invasive Ventilation Targeting Expiratory Flow Limitation in Severe Hypercapnic COPD.

• Status: Suspended
• Phase: N/A
• Study type: Interventional
• Enrollment: 48 (estimated)
• Sponsor: McGill University Health Centre/Research Institute of the McGill University Health Centre · Academic / Other
• Sex: All
• Age: —
• Healthy volunteers: Not accepted

Summary

In this 2-phase pilot study, the BiPAP A40 EFL will be evaluated in patients with severe COPD requiring home non-invasive ventilatory support with respect to patient-related and physiologic outcomes.

Detailed description

Objective phase 1: in patients with COPD already established on home NIV, to assess the effect of 2 months of the A40EFL on ventilator parameters, physiologic and patient-related outcomes (PRO), in comparison to the patients' usual settings as prescribed by their treating physician. The two primary outcomes will be the nightly duration of NIV use and NIV-related symptoms (S3-NIV questionnaire). Patient preference will be a secondary outcome. Objective phase 2 : In hypercapnic patients with COPD with a prior hypercapnic exacerbation requiring NIV in hospital, to obtain preliminary data regarding the impact of home NIV using the A40EFL on COPD exacerbations and physiologic and patient-related outcomes. The primary outcome will be the number of hospitalizations over 12 months on A40EFL. Secondary outcomes will include descriptive data on number of exacerbations not requiring hospitalization but treated with antibiotics or prednisone. Additional secondary outcomes, physiologic and PRO, for both phases 1 \& 2, will be evaluated.

Conditions

• COPD

Interventions

Type	Name	Description
DEVICE	BiPAP EFL	Non-invasive ventilation using a novel ventilatory mode targeting expiratory flow limitation in COPD

Timeline

• Start date: 2025-10-01
• Primary completion: 2027-12-01
• Completion: 2027-12-01
• First posted: 2021-11-05
• Last updated: 2024-03-15

Locations

1 site across 1 country: Canada