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

NCT05109754 | Suspended

• 1 other identifier: 2022-8261
• Study Type: interventional
• Target: 48
• Locations: 1 country
• Sites: 1

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.

Conditions

COPD

Outcome Measures

Primary Outcomes (3)

• The nightly duration of Non-Invasive Ventilation use

  (Phase 1) Measured in hours and minutes.

  2 months

• 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.

  2 months

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

  (phase 2)

  12 months

Study Arms (1)

BPAP EFL

EXPERIMENTAL

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

Device: BiPAP EFL

Interventions

BiPAP EFL DEVICE

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

BPAP EFL

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• McGill University Health Centre/Research Institute of the McGill University Health Centre: lead
• University of Calgary: collaborator

Study Sites (1)

MUHC

Montreal, Quebec, H4A 3J1, Canada

Location

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Marta Kaminska, MD, MSc

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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Scientist

Study Record Dates

• First Submitted: October 27, 2021
• First Posted: November 5, 2021
• Study Start: October 1, 2025
• Primary Completion (Estimated): December 1, 2027
• Study Completion (Estimated): December 1, 2027
• Last Updated: March 15, 2024

Record last verified: 2024-03

Locations

CA (1)