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Home Non-Invasive Ventilation Targeting Expiratory Flow Limitation in Severe Hypercapnic COPD. | Clinical Trials | Clareo Health

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

NCT05109754•McGill University Health Centre/Research Institute of the McGill University Health Centre

View on ClinicalTrials.gov

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.

Eligibility

Age

All ages

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Phase 1:
•severe COPD with FEV1\<50%, using home NIV successfully for at least 2 months through the Quebec National Program for Home Ventilatory Assistance (NPHVA).
•Phase 2:
•severe COPD with FEV1\<50%; pCO2\>= 52 on arterial or capillary blood gas measured 2-4 weeks after acute NIV use and discontinuation

Exclusion Criteria

•Phase 1
•COPD exacerbation requiring treatment (including hospitalization) within the last 6 weeks; surgical procedure or major illness within the last 3 months; kyphoscoliosis, neuromuscular disease, other lung disease (e.g. fibrosis); active cancer; expected survival \< 2 months; listed on the transplant list.
•Phase 2:
•any additional condition potentially predisposing to hypercapnia such as: obesity (BMI\> 30kg/m2), kyphoscoliosis, neuromuscular disease, other lung disease (e.g. fibrosis), severe obstructive sleep apnea (AHI\>30/h on prior testing if available, but will not test as part of the study); active cancer; expected survival \< 2 months; listed on the transplant list at start of study.

Locations (1)

MUHC

Montreal, Quebec, Canada

Key Dates

Start Date

October 1, 2025

Primary Completion Date

December 1, 2027

Completion Date

December 1, 2027

Last Updated

March 15, 2024

Enrollment

ESTIMATED participants

Conditions

COPD

Interventions

BiPAP EFL

DEVICE

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Chronic Obstructive Pulmonary Disease (COPD)

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: March 15, 2024Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

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

Inclusion Criteria

Exclusion Criteria

cfMSC Stem Cell Therapy Targeting COPD

Effect of Telenursing on Oral Health

Emotional-distress-based Integrated Care Programme in Patients With an Acute Exacerbation of COPD

Probiotics in Pulmonaty Rehabilitation for COPD

Effects of Eccentric Exercise Training in Patients With COPD

A Clinical Study of Inhaled Nitric Oxide in Patients With Chronic Obstructive Pulmonary Disease