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

Primary Purpose

Chronic Obstructive Pulmonary Disease

Status
Terminated
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
NIV Device + LTOT
LTOT
Sponsored by
University Hospital, Grenoble
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Chronic Obstructive Pulmonary Disease focused on measuring COPD, Oxygenation Long term, Non invasive Ventilation, Nocturnal Hypoventilation

Eligibility Criteria

18 Years - 85 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • University Hospital Grenoble

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

NIV Device + LTOT

LTOT

Arm Description

administration of ventilary support, without using an invasive artificial airway

standard treatment, without NIV

Outcomes

Primary Outcome Measures

Nocturnal transcutaneous pressure CO2 (PtCO2)
Measurement of nocturnal PtCO2 using the SenTec system

Secondary Outcome Measures

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

Full Information

First Posted
January 22, 2018
Last Updated
February 9, 2021
Sponsor
University Hospital, Grenoble
Collaborators
AGIR à Dom, ResMed
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1. Study Identification

Unique Protocol Identification Number
NCT03584269
Brief Title
Innovation in NOn Invasive Ventilation in COPD Patients Treated by Long Term Oxygen Therapy
Acronym
INOV-LTOT
Official Title
Non Invasive Ventilation and Nocturnal Alveolar Hypoventilation in Patients With Chronic Obstructive Pulmonary Disease (COPD) Treated by Long Term Oxygen Therapy at Home
Study Type
Interventional

2. Study Status

Record Verification Date
February 2021
Overall Recruitment Status
Terminated
Why Stopped
Recruiting difficulties
Study Start Date
June 28, 2018 (Actual)
Primary Completion Date
July 9, 2018 (Actual)
Study Completion Date
September 23, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Grenoble
Collaborators
AGIR à Dom, ResMed

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Obstructive Pulmonary Disease
Keywords
COPD, Oxygenation Long term, Non invasive Ventilation, Nocturnal Hypoventilation

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
45 (Actual)

8. Arms, Groups, and Interventions

Arm Title
NIV Device + LTOT
Arm Type
Experimental
Arm Description
administration of ventilary support, without using an invasive artificial airway
Arm Title
LTOT
Arm Type
Active Comparator
Arm Description
standard treatment, without NIV
Intervention Type
Device
Intervention Name(s)
NIV Device + LTOT
Intervention Description
Respiratory assistance by a facial mask without intubation or tracheotomy
Intervention Type
Device
Intervention Name(s)
LTOT
Intervention Description
Long term oxygenatory tyherapy without NIV
Primary Outcome Measure Information:
Title
Nocturnal transcutaneous pressure CO2 (PtCO2)
Description
Measurement of nocturnal PtCO2 using the SenTec system
Time Frame
3 months
Secondary Outcome Measure Information:
Title
Saint George's Respiratory Questionnaire
Description
Measure of quality of life
Time Frame
3 months
Title
FEV1
Description
Pulmonary function tests
Time Frame
3 months
Title
Vital capacity
Description
Pulmonary function tests
Time Frame
3 months
Title
PaO2
Description
Blood gases
Time Frame
3 months
Title
PaCO2
Description
Blood gases
Time Frame
3 months
Title
Steps per day
Description
Physical activity measured at home (one week)
Time Frame
3 months
Title
Time in supine and sitting positions
Description
Physical activity measured at home (one week)
Time Frame
3 months
Title
Energy expenditure
Description
Physical activity measured at home (one week)
Time Frame
3 months
Title
Heart Rate
Description
Physiological responses during the Semi paced 3-min Chair rise test
Time Frame
3 months
Title
SaO2
Description
Physiological responses during the Semi paced 3-min Chair rise test
Time Frame
3 months
Title
Dyspnea score
Description
Symptoms during the Semi paced 3-min Chair rise test
Time Frame
3 months
Title
Fatigue score
Description
Symptoms during the Semi paced 3-min Chair rise test
Time Frame
3 months
Title
Cholesterol
Description
Biological parameters
Time Frame
3 months
Title
Triglycerides
Description
Biological parameters
Time Frame
3 months
Title
Fasting Glucose
Description
Biological parameters
Time Frame
3 months
Title
CRPus
Description
Biological parameters
Time Frame
3 months
Title
HBA1c
Description
Biological parameters
Time Frame
3 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jean-Louis Pépin, Pr, PhD
Organizational Affiliation
University Grenoble Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
University Hospital Grenoble
City
La Tronche
ZIP/Postal Code
38700
Country
France

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
27028990
Citation
Ko FW, Chan KP, Hui DS, Goddard JR, Shaw JG, Reid DW, Yang IA. Acute exacerbation of COPD. Respirology. 2016 Oct;21(7):1152-65. doi: 10.1111/resp.12780. Epub 2016 Mar 30.
Results Reference
result
PubMed Identifier
27698560
Citation
Dretzke J, Moore D, Dave C, Mukherjee R, Price MJ, Bayliss S, Wu X, Jordan RE, Turner AM. The effect of domiciliary noninvasive ventilation on clinical outcomes in stable and recently hospitalized patients with COPD: a systematic review and meta-analysis. Int J Chron Obstruct Pulmon Dis. 2016 Sep 16;11:2269-2286. doi: 10.2147/COPD.S104238. eCollection 2016.
Results Reference
result
PubMed Identifier
24912564
Citation
Borel JC, Pepin JL, Pison C, Vesin A, Gonzalez-Bermejo J, Court-Fortune I, Timsit JF. Long-term adherence with non-invasive ventilation improves prognosis in obese COPD patients. Respirology. 2014 Aug;19(6):857-65. doi: 10.1111/resp.12327. Epub 2014 Jun 9.
Results Reference
result
PubMed Identifier
25066329
Citation
Kohnlein T, Windisch W, Kohler D, Drabik A, Geiseler J, Hartl S, Karg O, Laier-Groeneveld G, Nava S, Schonhofer B, Schucher B, Wegscheider K, Criee CP, Welte T. Non-invasive positive pressure ventilation for the treatment of severe stable chronic obstructive pulmonary disease: a prospective, multicentre, randomised, controlled clinical trial. Lancet Respir Med. 2014 Sep;2(9):698-705. doi: 10.1016/S2213-2600(14)70153-5. Epub 2014 Jul 24.
Results Reference
result
PubMed Identifier
7633704
Citation
Meecham Jones DJ, Paul EA, Jones PW, Wedzicha JA. Nasal pressure support ventilation plus oxygen compared with oxygen therapy alone in hypercapnic COPD. Am J Respir Crit Care Med. 1995 Aug;152(2):538-44. doi: 10.1164/ajrccm.152.2.7633704.
Results Reference
result

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

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