Clinical trial NCT03584269: Innovation in NOn Invasive Ventilation in COPD Patients Treated by Long Term Oxygen Therapy
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
Overall status: TERMINATED
Phase: NA
Conditions: Chronic Obstructive Pulmonary Disease
Keywords: COPD
Oxygenation Long term
Non invasive Ventilation
Nocturnal Hypoventilation
Lead sponsor: University Hospital, Grenoble
Sponsor class: OTHER
Collaborators: name: AGIR à Dom
name: ResMed
First posted: 2018-07-12
Enrollment: 45
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Nocturnal transcutaneous pressure CO2 (PtCO2)
timeFrame: 3 months
Secondary outcomes:
measure: Saint George's Respiratory Questionnaire
timeFrame: 3 months
measure: FEV1
timeFrame: 3 months
measure: Vital capacity
timeFrame: 3 months
measure: PaO2
timeFrame: 3 months
measure: PaCO2
timeFrame: 3 months
measure: Steps per day
timeFrame: 3 months
measure: Time in supine and sitting positions
timeFrame: 3 months
measure: Energy expenditure
timeFrame: 3 months
measure: Heart Rate
timeFrame: 3 months
measure: SaO2
timeFrame: 3 months
measure: Dyspnea score
timeFrame: 3 months
measure: Fatigue score
timeFrame: 3 months
measure: Cholesterol
timeFrame: 3 months
measure: Triglycerides
timeFrame: 3 months
measure: Fasting Glucose
timeFrame: 3 months
measure: CRPus
timeFrame: 3 months
measure: HBA1c
timeFrame: 3 months
Other outcomes:
Locations:
city: La Tronche
country: France
facility: University Hospital Grenoble
Study officials:
affiliation: University Grenoble Hospital
name: Jean-Louis Pépin, Pr, PhD
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.
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.
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.
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.