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

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ClinicalTrials.gov Identifier: NCT03584269
Recruitment Status : Recruiting
First Posted : July 12, 2018
Last Update Posted : July 12, 2018
Sponsor:
Collaborators:
AGIR à Dom
ResMed
Information provided by (Responsible Party):
University Hospital, Grenoble

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.

Condition or disease Intervention/treatment Phase
Chronic Obstructive Pulmonary Disease Device: NIV Device + LTOT Device: LTOT Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 38 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Actual Study Start Date : June 28, 2018
Estimated Primary Completion Date : October 10, 2019
Estimated Study Completion Date : April 10, 2020

Resource links provided by the National Library of Medicine


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




Primary Outcome Measures :
  1. Nocturnal transcutaneous pressure CO2 (PtCO2) [ Time Frame: 3 months ]
    Measurement of nocturnal PtCO2 using the SenTec system


Secondary Outcome Measures :
  1. Saint George's Respiratory Questionnaire [ Time Frame: 3 months ]
    Measure of quality of life

  2. FEV1 [ Time Frame: 3 months ]
    Pulmonary function tests

  3. Vital capacity [ Time Frame: 3 months ]
    Pulmonary function tests

  4. PaO2 [ Time Frame: 3 months ]
    Blood gases

  5. PaCO2 [ Time Frame: 3 months ]
    Blood gases

  6. Steps per day [ Time Frame: 3 months ]
    Physical activity measured at home (one week)

  7. Time in supine and sitting positions [ Time Frame: 3 months ]
    Physical activity measured at home (one week)

  8. Energy expenditure [ Time Frame: 3 months ]
    Physical activity measured at home (one week)

  9. Heart Rate [ Time Frame: 3 months ]
    Physiological responses during the Semi paced 3-min Chair rise test

  10. SaO2 [ Time Frame: 3 months ]
    Physiological responses during the Semi paced 3-min Chair rise test

  11. Dyspnea score [ Time Frame: 3 months ]
    Symptoms during the Semi paced 3-min Chair rise test

  12. Fatigue score [ Time Frame: 3 months ]
    Symptoms during the Semi paced 3-min Chair rise test

  13. Cholesterol [ Time Frame: 3 months ]
    Biological parameters

  14. Triglycerides [ Time Frame: 3 months ]
    Biological parameters

  15. Fasting Glucose [ Time Frame: 3 months ]
    Biological parameters

  16. CRPus [ Time Frame: 3 months ]
    Biological parameters

  17. HBA1c [ Time Frame: 3 months ]
    Biological parameters



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Ages Eligible for Study:   18 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03584269


Contacts
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Contact: Jean-Louis Pépin, Pr, PhD +33 476 768 473 JPepin@chu-grenoble.fr
Contact: Marjorie Dole, CRA, PhD +33 476 766 918 mdole2@chu-grenoble.fr

Locations
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France
University Hospital Grenoble Recruiting
La Tronche, France, 38700
Contact: Jean-Louis Pépin, Pr, PhD    +33 476 768 473    JPepin@chu-grenoble.fr   
Contact: Marjorie Dole, CRA    +33 476 766 918    mdole2@chu-grenoble.fr   
Principal Investigator: Christian Brambilla, Pr         
Sub-Investigator: Renaud Tamisier, Pr         
Sub-Investigator: Marie Destors, MD         
Sponsors and Collaborators
University Hospital, Grenoble
AGIR à Dom
ResMed
Investigators
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Principal Investigator: Jean-Louis Pépin, Pr, PhD University Grenoble Hospital

Publications of Results:
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Responsible Party: University Hospital, Grenoble
ClinicalTrials.gov Identifier: NCT03584269     History of Changes
Other Study ID Numbers: 38RC17.117
First Posted: July 12, 2018    Key Record Dates
Last Update Posted: July 12, 2018
Last Verified: June 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by University Hospital, Grenoble:
COPD
Oxygenation Long term
Non invasive Ventilation
Nocturnal Hypoventilation

Additional relevant MeSH terms:
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Lung Diseases
Lung Diseases, Obstructive
Pulmonary Disease, Chronic Obstructive
Hypoventilation
Respiratory Tract Diseases
Respiratory Insufficiency
Respiration Disorders
Signs and Symptoms, Respiratory
Signs and Symptoms