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

Overview

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 Title of Study: “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

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: None (Open Label)
  • Study Primary Completion Date: October 10, 2019

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.

Interventions

  • Device: NIV Device + LTOT
    • Respiratory assistance by a facial mask without intubation or tracheotomy
  • Device: LTOT
    • Long term oxygenatory tyherapy without NIV

Arms, Groups and Cohorts

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

Clinical Trial Outcome Measures

Primary Measures

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

Secondary Measures

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

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: 85 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • University Hospital, Grenoble
  • Collaborator
    • AGIR à Dom
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Jean-Louis Pépin, Pr, PhD, Principal Investigator, University Grenoble Hospital
  • Overall Contact(s)
    • Jean-Louis Pépin, Pr, PhD, +33 476 768 473, JPepin@chu-grenoble.fr

Citations Reporting on Results

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. Review.

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. eCollection 2016. Review.

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.

Köhnlein T, Windisch W, Köhler D, Drabik A, Geiseler J, Hartl S, Karg O, Laier-Groeneveld G, Nava S, Schönhofer B, Schucher B, Wegscheider K, Criée 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.

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.

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