Chronic Obstructive Pulmonary DiseaseINOV-LTOTNCT03584269
Innovation in NOn Invasive Ventilation in COPD Patients Treated by Long Term Oxygen Therapy
A study testing NIV Device + LTOT and LTOT in people with Chronic Obstructive Pulmonary Disease, run by University Hospital, Grenoble at 1 site in France.
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. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Chronic Obstructive Pulmonary Disease
- What is being tested?
- NIV Device + LTOT and LTOT
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 45 participants
- Where
- 1 siteFrance
- Study dates
- 28 Jun 2018to 23 Sep 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- chronic obstructive pulmonary disease (COPD)
- on long term oxygen therapy (LTOT)
- affiliated to French social security system or equivalent
- informed consent signed
Who cannot join
- 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
- Persons who, according to the investigator, are expected no to meet all study obligations
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
Read the 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.
- Conditions
- Chronic Obstructive Pulmonary Disease
- Being tested
- NIV Device + LTOT, LTOT
- Keywords
- COPD, Oxygenation Long term, Non invasive Ventilation, Nocturnal Hypoventilation
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NIV Device + LTOTDevice
Respiratory assistance by a facial mask without intubation or tracheotomy
LTOTDevice
Long term oxygenatory tyherapy without NIV
| Study group | Role | What they receive |
|---|---|---|
| NIV Device + LTOT | Experimental | administration of ventilary support, without using an invasive artificial airway Receives: Device: NIV Device + LTOT |
| LTOT | Active comparator | standard treatment, without NIV Receives: Device: LTOT |
What is being measured
The primary outcome is the main question the study is designed to answer.
Nocturnal transcutaneous pressure CO2 (PtCO2)
Measurement of nocturnal PtCO2 using the SenTec system
Measured: 3 months
Secondary outcomes (17)
Saint George's Respiratory Questionnaire
Measure of quality of life
Measured: 3 months
FEV1
Pulmonary function tests
Measured: 3 months
Vital capacity
Pulmonary function tests
Measured: 3 months
PaO2
Blood gases
Measured: 3 months
PaCO2
Blood gases
Measured: 3 months
Steps per day
Physical activity measured at home (one week)
Measured: 3 months
Time in supine and sitting positions
Physical activity measured at home (one week)
Measured: 3 months
Energy expenditure
Physical activity measured at home (one week)
Measured: 3 months
Heart Rate
Physiological responses during the Semi paced 3-min Chair rise test
Measured: 3 months
SaO2
Physiological responses during the Semi paced 3-min Chair rise test
Measured: 3 months
Dyspnea score
Symptoms during the Semi paced 3-min Chair rise test
Measured: 3 months
Fatigue score
Symptoms during the Semi paced 3-min Chair rise test
Measured: 3 months
Cholesterol
Biological parameters
Measured: 3 months
Triglycerides
Biological parameters
Measured: 3 months
Fasting Glucose
Biological parameters
Measured: 3 months
CRPus
Biological parameters
Measured: 3 months
HBA1c
Biological parameters
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jul 2018
- Study start28 Jun 2018
- Primary completion9 Jul 2018
- Study completion23 Sep 2019
Why it stopped: Recruiting difficulties
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Chronic Obstructive Pulmonary DiseaseStudies of the same condition, open and under way.
- More trials run by University Hospital, GrenobleThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 45 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Grenoble
- Sponsor type
- University, hospital or other
- Collaborators
- AGIR à Dom, ResMed
- Responsible party
- Sponsor
- Investigators
- Jean-Louis Pépin, Pr, PhD, Principal investigator, University Grenoble Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03584269
- Sponsor's protocol ID
- 38RC17.117
- Acronym
- INOV-LTOT
- Status last verified
- Feb 2021
- First submitted
- 22 Jan 2018
- Last updated
- 10 Feb 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 27028990Dretzke 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.
PubMed 27698560Borel 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.
PubMed 24912564Kohnlein 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.
PubMed 25066329Meecham 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.
PubMed 7633704
Study at a glance
From the registry record, last updated by the sponsor on 10 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03584269
- Acronym / sponsor ID
- INOV-LTOT / 38RC17.117
- Conditions
- Chronic Obstructive Pulmonary Disease
- Keywords
- COPD, Oxygenation Long term, Non invasive Ventilation, Nocturnal Hypoventilation
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Recruiting difficulties
- Enrolment
- 45 participants (actual)
- Lead sponsor
- University Hospital, GrenobleUniversity, hospital or other
- Collaborators
- AGIR à Dom, ResMed
- Study start
- 28 Jun 2018 (actual)
- Primary completion
- 9 Jul 2018 (actual)
- Study completion
- 23 Sep 2019 (actual)
- First posted
- 12 Jul 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| NIV Device + LTOT | Experimental | Device: NIV Device + LTOTadministration of ventilary support, without using an invasive artificial airway |
| LTOT | Active comparator | Device: LTOTstandard treatment, without NIV |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- chronic obstructive pulmonary disease (COPD)
Key exclusion criteria (5 listed)
- 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
- Persons who, according to the investigator, are expected no to meet all study obligations
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| NIV Device + LTOTRespiratory assistance by a facial mask without intubation or tracheotomy | Device | NIV Device + LTOT |
| LTOTLong term oxygenatory tyherapy without NIV | Device | LTOT |
Primary outcome
Nocturnal transcutaneous pressure CO2 (PtCO2)
Time frame: 3 months
Measurement of nocturnal PtCO2 using the SenTec system
17 secondary outcomes
Saint George's Respiratory Questionnaire
Time frame: 3 months
FEV1
Time frame: 3 months
Vital capacity
Time frame: 3 months
PaO2
Time frame: 3 months
PaCO2
Time frame: 3 months
Steps per day
Time frame: 3 months
Time in supine and sitting positions
Time frame: 3 months
Energy expenditure
Time frame: 3 months
Heart Rate
Time frame: 3 months
SaO2
Time frame: 3 months
Dyspnea score
Time frame: 3 months
Fatigue score
Time frame: 3 months
Cholesterol
Time frame: 3 months
Triglycerides
Time frame: 3 months
Fasting Glucose
Time frame: 3 months
CRPus
Time frame: 3 months
HBA1c
Time frame: 3 months
Results and safety
The study was stopped early (reason given: Recruiting difficulties). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Feb 2021.
- Results publication: PubMed 27028990Ko 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.
- Results publication: PubMed 27698560Dretzke 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.
- Results publication: PubMed 24912564Borel 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.
- Results publication: PubMed 25066329Kohnlein 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.
- Results publication: PubMed 7633704Meecham 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.
- Individual participant dataSharing planned: No
Related trials for Chronic Obstructive Pulmonary Disease
Active, not recruiting
Symptoms and Functions in Patients With COPD and Chronic Bronchitis Switching From CIG to THS
COPD, Smoking
Not yet recruitingPhase 2/3
An Open-Label Extension Study to Evaluate Inhaled Treprostinil SMI in Participants With Pulmonary Hypertension Associated With Chronic Obstructive Pulmonary Disease (PH-COPD)
Pulmonary Hypertension Associated With Chronic Obstructive Pulmonary Disease
Not yet recruiting
The Aim of the Study is to Decipher the Alterations in Signalling Pathways of Skeletal Muscle Stem Cells (Satellite Cells (SCs)) in Individuals With COPD, as Well as to Examine the Effect of Exercise Training on SCs.
COPD (Chronic Obstructive Pulmonary Disease), Sarcopenia in Elderly
Not yet recruitingPhase 2
Study of Treprostinil Administered Via Soft Mist Inhaler (SMI) in Participants With Pulmonary Hypertension Associated With Chronic Obstructive Pulmonary Disease (PH-COPD)
Pulmonary Hypertension Associated With Chronic Obstructive Pulmonary Disease
RecruitingPhase 3
A Study to Investigate the Efficacy and Safety of Belumosudil Compared With Best Available Therapy in Participants Aged 12 Years or Older With Chronic Graft-versus-host Disease
Chronic Graft Versus Host Disease
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jean-Louis Pépin, Pr, PhD principal investigator
University Grenoble Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing NIV Device + LTOT and LTOT in people with Chronic Obstructive Pulmonary Disease, run by University Hospital, Grenoble at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 10 Feb 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: Recruiting difficulties). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Nocturnal transcutaneous pressure CO2 (PtCO2) (time frame: 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03584269, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Feb 2021.