Innovation in NOn Invasive Ventilation in COPD Patients Treated by Long Term Oxygen Therapy

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

TERMINATED

Clinical Phase

NA

Total Enrollment

45 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-06-28

Study Completion Date

2019-09-23

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

The aim of this study is to investigate the efficacy of non-invasive ventilation (NIV) on nocturnal hypoventilation in patients with chronic obstructive pulmonary disease (COPD) who are on long term oxygen therapy (LTOT) at home.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Efficacy of an Advanced Auto-titrating NIV in COPD

NCT04848012

Chronic Obstructive Pulmonary Disease Severe

SUSPENDED NA

Non-invasive Ventilation in Severe Chronic Obstructive Pulmonary Disease(COPD)

NCT00710541

Chronic Obstructive Pulmonary Disease Hypercapnia

TERMINATED NA

Home Non Invasive Ventilation for COPD Patients

NCT03221101

Chronic Obstructive Pulmonary Disease Hypercapnic Respiratory Failure

RECRUITING NA

Exacerbation Prevention GOLD IV COPD With Non Invasive Mechanical Ventilation

NCT01481727

Chronic Obstructive Pulmonary Disease

UNKNOWN PHASE4

Cohort of Respiratory Failure Patients Treated for the First Time With Non-Invasive Ventilation at Home

NCT02346305

Respiratory Insufficiency

UNKNOWN

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

This is a prospective, randomized, open labelled study. The primary outcome is nocturnal transcutaneous CO2 (PtCO2) after 3 months of non-invasive ventilation. Three hundred COPD patients on LTOT will be screened and assessed by pulmonary function tests, blood gases and nocturnal PtCO2 at their home. This will allow the determination of the prevalence of nocturnal hypoventilation in COPD patients on LTOT (a secondary outcome) and to select patients who meet the inclusion criteria for the RCT and randomization to NIV + LTOT or to continue LTOT alone (n=38). Patients will undergo the same assessments at the end of the three-month intervention period.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Chronic Obstructive Pulmonary Disease

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

NIV Device + LTOT

administration of ventilary support, without using an invasive artificial airway

Group Type EXPERIMENTAL

NIV Device + LTOT

Intervention Type DEVICE

Respiratory assistance by a facial mask without intubation or tracheotomy

LTOT

standard treatment, without NIV

Group Type ACTIVE_COMPARATOR

LTOT

Intervention Type DEVICE

Long term oxygenatory tyherapy without NIV

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

NIV Device + LTOT

Respiratory assistance by a facial mask without intubation or tracheotomy

Intervention Type DEVICE

LTOT

Long term oxygenatory tyherapy without NIV

Intervention Type DEVICE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* chronic obstructive pulmonary disease (COPD)

* on long term oxygen therapy (LTOT)
* affiliated to French social security system or equivalent
* informed consent signed

Exclusion Criteria

* Diurnal PtCO2 \>55mmHg
* Patient who has had an exacerbation of COPD requiring a change in management or treatment in the last 4 weeks prior to the inclusion visit.
* Pregnant or breathfeeding women
* Prisonners or persons who require protection by the law
* Exclusion period from another study
* Persons who, according to the investigator, are expected no to meet all study obligations

Minimum Eligible Age

18 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No