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

Primary Purpose

COPD

Status

Not yet recruiting

Phase

Not Applicable

Locations

Study Type

Interventional

Intervention

BiPAP EFL

About this trial

This is an interventional treatment trial for COPD

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept 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.

Sites / Locations

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

BPAP EFL

Arm Description

Phase 1: use device for 2 months Phase 2: use device for 12 months

Outcomes

Primary Outcome Measures

The nightly duration of Non-Invasive Ventilation use

(Phase 1) Measured in hours and minutes.

S3-NIV (Non-Invasive Ventilation) questionnaire score

NIV-related symptoms (Phase 1) Dupuis-Lozeron E, Gex G, Pasquina P, et al. Development and validation of a simple tool for the assessment of home noninvasive ventilation: the S3-NIV questionnaire. Eur Respir J 2018; 52: 1801182. The lowest score corresponds to highest adverse impact of disease and treatment.

The number of hospitalizations during the study period, compared with year prior to inclusion

(phase 2)

Secondary Outcome Measures

Full Information

NCT ID

NCT05109754

First Posted

October 27, 2021

Last Updated

August 22, 2022

Sponsor

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

Collaborators

University of Calgary

1. Study Identification

Unique Protocol Identification Number

NCT05109754

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

August 2022

Overall Recruitment Status

Not yet recruiting

Study Start Date

October 2022 (Anticipated)

Primary Completion Date

December 2024 (Anticipated)

Study Completion Date

June 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

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

Collaborators

University of Calgary

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

COPD

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Sequential Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

48 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

BPAP EFL

Arm Type

Experimental

Arm Description

Phase 1: use device for 2 months Phase 2: use device for 12 months

Intervention Type

Device

Intervention Name(s)

BiPAP EFL

Intervention Description

Non-invasive ventilation using a novel ventilatory mode targeting expiratory flow limitation in COPD

Primary Outcome Measure Information:

Title

The nightly duration of Non-Invasive Ventilation use

Description

(Phase 1) Measured in hours and minutes.

Time Frame

2 months

Title

S3-NIV (Non-Invasive Ventilation) questionnaire score

Description

Time Frame

2 months

Title

The number of hospitalizations during the study period, compared with year prior to inclusion

Description

(phase 2)

Time Frame

12 months

10. Eligibility

Sex

All

Accepts Healthy Volunteers

Eligibility Criteria

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.

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Francine Noel, MD

Phone

514-934-1934

francine.noel@muhc.mcgill.ca

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Marta Kaminska, MD, MSc

Organizational Affiliation

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

Official's Role

Principal Investigator

12. IPD Sharing Statement

Learn more about this trial

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

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