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

Grenoble Alpes University Hospital Center (CHU) logo

Grenoble Alpes University Hospital Center (CHU)

Status

Terminated

Conditions

Chronic Obstructive Pulmonary Disease

Treatments

Device: LTOT
Device: NIV Device + LTOT

Study type

Interventional

Funder types

Other
Industry

Identifiers

NCT03584269
38RC17.117

Details and patient eligibility

About

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.

Full 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.

Enrollment

45 patients

Sex

All

Ages

18 to 85 years old

Volunteers

No 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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

45 participants in 2 patient groups

NIV Device + LTOT
Experimental group
Description:
administration of ventilary support, without using an invasive artificial airway
Treatment:
Device: NIV Device + LTOT
LTOT
Active Comparator group
Description:
standard treatment, without NIV
Treatment:
Device: LTOT

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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