Innovation in NOn Invasive Ventilation in COPD Patients Treated by Long Term Oxygen Therapy (INOV-LTOT)

February 9, 2021 updated by: University Hospital, Grenoble

Non Invasive Ventilation and Nocturnal Alveolar Hypoventilation in Patients With Chronic Obstructive Pulmonary Disease (COPD) Treated by Long Term Oxygen Therapy at Home

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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Interventional

Enrollment (Actual)

45

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • La Tronche, France, 38700
        • University Hospital Grenoble

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 85 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: NIV Device + LTOT
administration of ventilary support, without using an invasive artificial airway
Device: NIV Device + LTOT
Respiratory assistance by a facial mask without intubation or tracheotomy
ACTIVE_COMPARATOR: LTOT
standard treatment, without NIV
Device: LTOT
Long term oxygenatory tyherapy without NIV

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Nocturnal transcutaneous pressure CO2 (PtCO2)
Time Frame: 3 months
Measurement of nocturnal PtCO2 using the SenTec system
3 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Saint George's Respiratory Questionnaire
Time Frame: 3 months
Measure of quality of life
3 months
FEV1
Time Frame: 3 months
Pulmonary function tests
3 months
Vital capacity
Time Frame: 3 months
Pulmonary function tests
3 months
PaO2
Time Frame: 3 months
Blood gases
3 months
PaCO2
Time Frame: 3 months
Blood gases
3 months
Steps per day
Time Frame: 3 months
Physical activity measured at home (one week)
3 months
Time in supine and sitting positions
Time Frame: 3 months
Physical activity measured at home (one week)
3 months
Energy expenditure
Time Frame: 3 months
Physical activity measured at home (one week)
3 months
Heart Rate
Time Frame: 3 months
Physiological responses during the Semi paced 3-min Chair rise test
3 months
SaO2
Time Frame: 3 months
Physiological responses during the Semi paced 3-min Chair rise test
3 months
Dyspnea score
Time Frame: 3 months
Symptoms during the Semi paced 3-min Chair rise test
3 months
Fatigue score
Time Frame: 3 months
Symptoms during the Semi paced 3-min Chair rise test
3 months
Cholesterol
Time Frame: 3 months
Biological parameters
3 months
Triglycerides
Time Frame: 3 months
Biological parameters
3 months
Fasting Glucose
Time Frame: 3 months
Biological parameters
3 months
CRPus
Time Frame: 3 months
Biological parameters
3 months
HBA1c
Time Frame: 3 months
Biological parameters
3 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Grenoble

Collaborators

ResMed
AGIR à Dom

Investigators

  • Principal Investigator: Jean-Louis Pépin, Pr, PhD, University Grenoble Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

June 28, 2018

Primary Completion (ACTUAL)

July 9, 2018

Study Completion (ACTUAL)

September 23, 2019

Study Registration Dates

First Submitted

January 22, 2018

First Submitted That Met QC Criteria

July 10, 2018

First Posted (ACTUAL)

July 12, 2018

Study Record Updates

Last Update Posted (ACTUAL)

February 10, 2021

Last Update Submitted That Met QC Criteria

February 9, 2021

Last Verified

February 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 38RC17.117

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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