NCT03584269

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
45

participants targeted

Target at P25-P50 for not_applicable chronic-obstructive-pulmonary-disease

Timeline
Completed

Started Jun 2018

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 22, 2018

Completed
5 months until next milestone

Study Start

First participant enrolled

June 28, 2018

Completed
11 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 9, 2018

Completed
3 days until next milestone

First Posted

Study publicly available on registry

July 12, 2018

Completed
1.2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

September 23, 2019

Completed
Last Updated

February 10, 2021

Status Verified

February 1, 2021

Enrollment Period

11 days

First QC Date

January 22, 2018

Last Update Submit

February 9, 2021

Conditions

Chronic Obstructive Pulmonary Disease

Keywords

COPDOxygenation Long termNon invasive VentilationNocturnal Hypoventilation

Outcome Measures

Primary Outcomes (1)

  • Nocturnal transcutaneous pressure CO2 (PtCO2)

    Measurement of nocturnal PtCO2 using the SenTec system

    3 months

Secondary Outcomes (17)

  • Saint George's Respiratory Questionnaire

    3 months

  • FEV1

    3 months

  • Vital capacity

    3 months

  • PaO2

    3 months

  • PaCO2

    3 months

  • +12 more secondary outcomes

Study Arms (2)

NIV Device + LTOT

EXPERIMENTAL

administration of ventilary support, without using an invasive artificial airway

Device: NIV Device + LTOT

LTOT

ACTIVE COMPARATOR

standard treatment, without NIV

Device: LTOT

Interventions

NIV Device + LTOTDEVICE

Respiratory assistance by a facial mask without intubation or tracheotomy

NIV Device + LTOT
LTOTDEVICE

Long term oxygenatory tyherapy without NIV

LTOT

Eligibility Criteria

Age18 Years - 85 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • chronic obstructive pulmonary disease (COPD)
  • on long term oxygen therapy (LTOT)
  • affiliated to French social security system or equivalent
  • informed consent signed

You may not qualify if:

  • Diurnal PtCO2 \>55mmHg
  • Pregnant or breathfeeding women
  • Prisonners or persons who require protection by the law
  • Persons who, according to the investigator, are expected no to meet all study obligations

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Hospital Grenoble

La Tronche, 38700, France

Location

Related Publications (5)

  • 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.

    PMID: 27028990RESULT

  • 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.

    PMID: 27698560RESULT

  • 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.

    PMID: 24912564RESULT

  • 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.

    PMID: 25066329RESULT

  • 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.

    PMID: 7633704RESULT

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Condition Hierarchy (Ancestors)

Lung Diseases, ObstructiveLung DiseasesRespiratory Tract DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Jean-Louis Pépin, Pr, PhD

    University Grenoble Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 22, 2018

First Posted

July 12, 2018

Study Start

June 28, 2018

Primary Completion

July 9, 2018

Study Completion

September 23, 2019

Last Updated

February 10, 2021

Record last verified: 2021-02

Data Sharing

IPD Sharing
Will not share

Locations

FR(1)