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

Chronic Obstructive Pulmonary Disease Clinical Trial

— INOV-LTOT  

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT03584269
• Other study ID #: 38RC17.117
• Status: Terminated
• Phase: N/A
• Start date: June 28, 2018
• Est. completion date: September 23, 2019

Study information

• Verified date: February 2021
• Source: University Hospital, Grenoble
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 45
• Est. completion date: September 23, 2019
• Est. primary completion date: July 9, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 85 Years

Eligibility

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

Related Conditions & MeSH terms

• Chronic Obstructive Pulmonary Disease
• Hypoventilation
• Lung Diseases
• Lung Diseases, Obstructive
• Pulmonary Disease, Chronic Obstructive

Intervention

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

Locations

Country	Name	City	State
France	University Hospital Grenoble	La Tronche

Sponsors (3)

Lead Sponsor	Collaborator
University Hospital, Grenoble	AGIR à Dom, ResMed

Country where clinical trial is conducted

France, 

References & Publications (5)

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 — View 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. — View 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. Review. — View Citation

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 obstruct — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Nocturnal transcutaneous pressure CO2 (PtCO2)	Measurement of nocturnal PtCO2 using the SenTec system	3 months
Secondary	Saint George's Respiratory Questionnaire	Measure of quality of life	3 months
Secondary	FEV1	Pulmonary function tests	3 months
Secondary	Vital capacity	Pulmonary function tests	3 months
Secondary	PaO2	Blood gases	3 months
Secondary	PaCO2	Blood gases	3 months
Secondary	Steps per day	Physical activity measured at home (one week)	3 months
Secondary	Time in supine and sitting positions	Physical activity measured at home (one week)	3 months
Secondary	Energy expenditure	Physical activity measured at home (one week)	3 months
Secondary	Heart Rate	Physiological responses during the Semi paced 3-min Chair rise test	3 months
Secondary	SaO2	Physiological responses during the Semi paced 3-min Chair rise test	3 months
Secondary	Dyspnea score	Symptoms during the Semi paced 3-min Chair rise test	3 months
Secondary	Fatigue score	Symptoms during the Semi paced 3-min Chair rise test	3 months
Secondary	Cholesterol	Biological parameters	3 months
Secondary	Triglycerides	Biological parameters	3 months
Secondary	Fasting Glucose	Biological parameters	3 months
Secondary	CRPus	Biological parameters	3 months
Secondary	HBA1c	Biological parameters	3 months