Adherence, TreatmentHIGH-FLOWNCT04281316
High-Flow in Hypercapnic Stable COPD Patients
A study testing Nasal High Flow installation, Non Invasive Ventilation and Training session in people with Adherence, Treatment, run by University Hospital, Grenoble at 1 site in France.
Trial summary
Monocentric, prospective, open, randomized 1:1, controlled study to evaluate the impact of nasal high-flow (NHF) on nocturnal transcutaneous PCO2 (PtCO2) compared to non-invasive ventilation ± Long-Term Oxygen Therapy (LTOT) in patients with a Chronic obstructive pulmonary disease (COPD)-related hypercapnic… Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Adherence, Treatment
- What is being tested?
- Nasal High Flow installation, Non Invasive Ventilation and Training session
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 3 participants
- Where
- 1 siteFrance
- Study dates
- 23 Sep 2020to 16 Dec 2021
- 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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diagnosed with COPD (FEV1/FVC < 70%) and long term indication for home NIV for initiated at least 3 months prior the inclusion.
- Compliance with NIV (less than 5 hours and more than 1 hour) per night on average during the last 3 months prior to inclusion.
- Naïve to Nasal High Flow (NHF) therapy, i.e. having not used NHF in the last 6 months prior to inclusion.
- Able to understand, follow objectives and methods of protocol in French language.
- Patient affiliated to social security insurance or beneficiary of social health insurance.
- Willing and able to give written Informed Consent and to comply with the requirements of the study protocol.
Who cannot join
- Significant uncontrolled cardiac disease (investigator judgment), and/or Left Ventricular Ejection Fraction (LVEF) < 45%.
- Known co-existing obstructive sleep apnea requiring expiratory pressure above 6 cmH20.
- Severe nasal obstruction, previous upper airway surgery preventing the usage of NHF, or, at the discretion of investigator, any other contraindication for using the NHF.
- Patients who are unable or unwilling to give informed consent.
- Participating in another research study.
- Patient protected by the Law, under guardianship or curators.
- Pregnancy and nursing mothers
- Patient not covered by a health insurance.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Impact of Nasal High Flow (NHF) Versus Home Non-invasive Ventilation (NIV) on Nocturnal Transcutaneous PCO2 (PtCO2) in Stable COPD Patients: A Non-inferiority Study
Monocentric, prospective, open, randomized 1:1, controlled study to evaluate the impact of nasal high-flow (NHF) on nocturnal transcutaneous PCO2 (PtCO2) compared to non-invasive ventilation ± Long-Term Oxygen Therapy (LTOT) in patients with a Chronic obstructive pulmonary disease (COPD)-related hypercapnic respiratory failure.
Read the detailed description
Chronic obstructive pulmonary disease (COPD) is a growing global health concern, causing considerable health-related costs and increased mortality. COPD is nowadays considered a complex, heterogeneous and systemic condition.
In the late stage of the disease, non-invasive ventilation (NIV) is widely prescribed either to treat acute hypercapnic respiratory failure during COPD exacerbations or for long term home management.
A meta-analysis has shown that higher daytime PaCO2 occurred in home NIV treated COPD patients when NIV compliance is less than 5 h/day. Thus, an optimal NIV adherence is a key target for controlling nocturnal and diurnal hypoventilation and improving prognosis.
COPD is the clinical scenario during which a good NIV adherence is difficult to achieve. Particularly, in COPDs exhibiting hyperinflation, NIV can aggravate dynamic hyperinflation resulting in unrewarded inspiratory efforts, poor sleep and low NIV compliance. Alternatives to NIV are then desirable in this specific subgroup of hypercapnic COPD with poor adherence to NIV.
During this trial, stable COPD patients treated by long term home Non-Invasive Ventilation (NIV) treatment following French national recommendations and exhibiting a NIV compliance of (less than 5 hours and more than 1 hour) per day in the last 3 months prior to inclusion will be randomized via a secure electronic website to either continue with their current NIV treatment or receive the nasal high flow (NHF) treatment delivered by myAirvo2 during 3 months Nasal High-Flow (NHF) is a treatment delivering heated, humidified, and optionally oxygen-enriched air at high flow rates through a nasal cannula. The main physiologic effects of NHF are an improvement in gas exchanges including a reduction in hypercapnia, an optimization in breathing patterns with a reduction of work of breathing. Nasal High-Flow (NHF) is delivered via a comfortable nasal interface and has demonstrated good treatment adherence.
The investigators hypothesize that in COPD-related hypercapnic chronic respiratory failure with limited compliance to NIV (less than 5 hours per night), nasal High-Flow (NHF) will be non-inferior for controlling nocturnal hypoventilation and might improve daytime subjective patients centered outcomes, physical activity and nocturnal adherence to treatment.
- Conditions
- Adherence, Treatment
- Being tested
- Nasal High Flow installation, Non Invasive Ventilation, Training session, Education session
- Keywords
- non-compliance, NIV, NHF, COPD, hypercapnic respiratory failure
- Medical subject headings
- Treatment Adherence and Compliance, Pulmonary Disease, Chronic Obstructive, Respiratory Insufficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nasal High Flow installationDevice
Also called MyAirvo Device
Participants randomized in NHF group will receive the nasal high flow (NHF) treatment delivered by myAirvo2.
Nasal High-Flow (NHF) is a treatment delivering heated, humidified, and optionally oxygen-enriched, air at high flow rates through a nasal cannula. The physiologic effects of NHF are an improvement in gas exchanges including a reduction in hypercarbia an optimization in breathing patterns with a reduction of work of breathing and high compliance as delivered via a comfortable nasal interface
Non Invasive VentilationDevice
Participants randomized in the Non Invasive Ventilation group will receive treatment as in their usual care.
Training sessionOther
The patients in the Nasal High Flow (MyAirvo) arm will receive two hours training adaptation session in the hospital
Education sessionOther
Participants randomized in the Non Invasive Ventilation group will receive an additional educational session of one hour for improving compliance.
| Study group | Role | What they receive |
|---|---|---|
| Non Invasive Ventilation device group | Active comparator | The patients in the NIV arm will receive treatment as in their usual care with an additional educational session of one hour for improving compliance. Receives: Device: Non Invasive Ventilation; Other: Education session |
| Nasal High Flow (MyAirvo) device group | Experimental | The patients in the NHF arm will receive NHF treatment and two hours training adaptation session will be conducted in the hospital. Receives: Device: Nasal High Flow installation; Other: Training session |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes on nocturnal parameters with the nasal high-flow (NHF) compared to non-invasive ventilation in patients with a COPD-related hypercapnic respiratory failure.
Differences in mean overnight transcutaneous PtCO2 measurement
Measured: between night at day 1 (baseline) and night at day 90 (3 months after)
Secondary outcomes (15)
Evaluation the impact of nasal high-flow (NHF) on other nocturnal parameters compared to non-invasive ventilation ± LTOT compared to non-invasive ventilation in patients with a COPD-related hypercapnic respiratory failure.
Maximum PtCO2
Measured: between night at day 1 (baseline) and night at day 90 (3 months after)
Treatment adherence
Treatment adherence measured objectively by download of NIV software data and for NHF (myAirvo2) by hour meter \& daily average of usage (screen display)
Measured: between night at day 1 (baseline) and night at day 90 (3 months after)
Daytime blood gas values in ambient air
PaCO2 \& PaO2 in ambient air will be measured by blood gas sample in NHF group compared de NIV group
Measured: between day 0 (inclusion) and day 97 (end of the study)
Other nocturnal parameter
Overnight Sp02 will be evaluated by nocturnal oximetry at home in order to determine: mean nocturnal SaO2, nadir nocturnal SaO2, cumulative time spent below 90% of SaO2 (CT<90%), Oxygen Desaturation Index.
Measured: between night at day 1 (baseline) and night at day 90 (3 months after)
Physical activity
An actimetry will allow evaluating physical activity (number of steps)
Measured: for 7 days from the day 1 and for 7 days from the day 90
Sleep activity
An actimetry will allow evaluating total sleep time in minutes
Measured: between night at day 1 (baseline) and night at day 90 (3 months after)
Sleep activity
An actimetry will allow evaluating sleep onset latency in minutes
Measured: between night at day 1 (baseline) and night at day 90 (3 months after)
Sleep activity
An actimetry will allow evaluating sleep efficiency
Measured: between night at day 1 (baseline) and night at day 90 (3 months after)
Pulmonary function tests
Pulmonary function will be evaluated by routine patient care spirometry and will measure Vital capacity (VC) in liters
Measured: between day 0 and day 97
Pulmonary function tests
Pulmonary function will be evaluated by routine patient care spirometry and will measure Forced vital capacity (FVC) in liters
Measured: between day 0 and day 97
Pulmonary function tests
Pulmonary function will be evaluated by routine patient care spirometry and will measure Forced expiratory volume (FEV) in liters
Measured: between day 0 and day 97
Health related quality of life
Subjective functioning and quality of life will be measured by self-reporting questionnaire EQ-5D-5L
Measured: between day 0 and day 97
Health related quality of life
Subjective functioning and quality of life will be measured by self-reporting questionnaire SGRQ
Measured: between day 0 and day 97
Cardiovasculary function
Blood pressure measurements will be done three times during rest at five minutes intervals to provide informations on systolic, diastolic and mean blood pressure
Measured: between day 0 and day 97
Number of participants with adverse events will be assessed in each group by interrogating patients in order to assess the safety of nasal high-flow (NHF) treatment
All safety data will be recorded through an Electronic Medical Record as reported by the patient or recorded by the research nurse
Measured: between day 0 and day 97
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Feb 2020
- Study start23 Sep 2020
- Primary completion16 Dec 2021
- Study completion16 Dec 2021
Why it stopped: lack enrollment
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (10)Papers the sponsor has linked to this study.
- Other trials for Adherence, TreatmentStudies of the same condition, open and under way.
- 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
- 3 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Grenoble
- Sponsor type
- University, hospital or other
- Collaborators
- Icadom, Fisher and Paykel Healthcare
- Responsible party
- Sponsor
- Investigators
- Jean-Louis Pépin, MD PhD, Principal investigator, Laboratoire EFCR, CHU de Grenoble
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04281316
- Sponsor's protocol ID
- 38R19.250
- Acronym
- HIGH-FLOW
- Status last verified
- May 2022
- First submitted
- 11 Feb 2020
- Last updated
- 24 May 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Biener AI, Decker SL, Rohde F. Prevalence and Treatment of Chronic Obstructive Pulmonary Disease (COPD) in the United States. JAMA. 2019 Aug 20;322(7):602. doi: 10.1001/jama.2019.10241. No abstract available.
PubMed 31429884Riley CM, Sciurba FC. Diagnosis and Outpatient Management of Chronic Obstructive Pulmonary Disease: A Review. JAMA. 2019 Feb 26;321(8):786-797. doi: 10.1001/jama.2019.0131.
PubMed 30806700Houben-Wilke S, Augustin IM, Vercoulen JH, van Ranst D, Bij de Vaate E, Wempe JB, Spruit MA, Wouters EFM, Franssen FME. COPD stands for complex obstructive pulmonary disease. Eur Respir Rev. 2018 Jun 6;27(148):180027. doi: 10.1183/16000617.0027-2018. Print 2018 Jun 30.
PubMed 29875138Suh ES, Murphy PB, Hart N. Home mechanical ventilation for chronic obstructive pulmonary disease: What next after the HOT-HMV trial? Respirology. 2019 Aug;24(8):732-739. doi: 10.1111/resp.13484. Epub 2019 Feb 7.
PubMed 30729638Crimi C, Noto A, Princi P, Cuvelier A, Masa JF, Simonds A, Elliott MW, Wijkstra P, Windisch W, Nava S. Domiciliary Non-invasive Ventilation in COPD: An International Survey of Indications and Practices. COPD. 2016 Aug;13(4):483-90. doi: 10.3109/15412555.2015.1108960. Epub 2016 Jan 8.
PubMed 26744042Kohnlein T, Windisch W, Wegscheider K, Welte T. Non-invasive positive pressure ventilation for severe COPD--Authors' reply. Lancet Respir Med. 2014 Oct;2(10):e19. doi: 10.1016/S2213-2600(14)70215-2. No abstract available.
PubMed 25298063Murphy AM, Thomas A, Crinion SJ, Kent BD, Tambuwala MM, Fabre A, Pepin JL, Roche HM, Arnaud C, Ryan S. Intermittent hypoxia in obstructive sleep apnoea mediates insulin resistance through adipose tissue inflammation. Eur Respir J. 2017 Apr 19;49(4):1601731. doi: 10.1183/13993003.01731-2016. Print 2017 Apr.
PubMed 28424360Vanfleteren LEGW, Spruit MA, Wouters EFM, Franssen FME. Management of chronic obstructive pulmonary disease beyond the lungs. Lancet Respir Med. 2016 Nov;4(11):911-924. doi: 10.1016/S2213-2600(16)00097-7. Epub 2016 Jun 2.
PubMed 27264777Borel 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 24912564Struik FM, Lacasse Y, Goldstein RS, Kerstjens HA, Wijkstra PJ. Nocturnal noninvasive positive pressure ventilation in stable COPD: a systematic review and individual patient data meta-analysis. Respir Med. 2014 Feb;108(2):329-37. doi: 10.1016/j.rmed.2013.10.007. Epub 2013 Oct 14.
PubMed 24157199
Study at a glance
From the registry record, last updated by the sponsor on 24 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Nasal High Flow (NHF) Versus Home Non-invasive Ventilation (NIV) on Nocturnal Transcutaneous PCO2 (PtCO2) in Stable COPD Patients: A Non-inferiority Study
- ClinicalTrials.gov ID
- NCT04281316
- Acronym / sponsor ID
- HIGH-FLOW / 38R19.250
- Conditions
- Adherence, Treatment
- Keywords
- non-compliance, NIV, NHF, COPD, hypercapnic respiratory failure
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: lack enrollment
- Enrolment
- 3 participants (actual)
- Lead sponsor
- University Hospital, GrenobleUniversity, hospital or other
- Collaborators
- Icadom, Fisher and Paykel Healthcare
- Study start
- 23 Sep 2020 (actual)
- Primary completion
- 16 Dec 2021 (actual)
- Study completion
- 16 Dec 2021 (actual)
- First posted
- 24 Feb 2020 (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.
Monocentric, prospective, open, randomized 1:1, controlled study to evaluate the impact of nasal high-flow (NHF) on nocturnal transcutaneous PCO2 (PtCO2) compared to non-invasive ventilation ± Long-Term Oxygen Therapy (LTOT) in patients with a Chronic obstructive pulmonary disease (COPD)-related hypercapnic respiratory failure.
Detailed description
Chronic obstructive pulmonary disease (COPD) is a growing global health concern, causing considerable health-related costs and increased mortality. COPD is nowadays considered a complex, heterogeneous and systemic condition.
In the late stage of the disease, non-invasive ventilation (NIV) is widely prescribed either to treat acute hypercapnic respiratory failure during COPD exacerbations or for long term home management.
A meta-analysis has shown that higher daytime PaCO2 occurred in home NIV treated COPD patients when NIV compliance is less than 5 h/day. Thus, an optimal NIV adherence is a key target for controlling nocturnal and diurnal hypoventilation and improving prognosis.
COPD is the clinical scenario during which a good NIV adherence is difficult to achieve. Particularly, in COPDs exhibiting hyperinflation, NIV can aggravate dynamic hyperinflation resulting in unrewarded inspiratory efforts, poor sleep and low NIV compliance. Alternatives to NIV are then desirable in this specific subgroup of hypercapnic COPD with poor adherence to NIV.
During this trial, stable COPD patients treated by long term home Non-Invasive Ventilation (NIV) treatment following French national recommendations and exhibiting a NIV compliance of (less than 5 hours and more than 1 hour) per day in the last 3 months prior to inclusion will be randomized via a secure electronic website to either continue with their current NIV treatment or receive the nasal high flow (NHF) treatment delivered by myAirvo2 during 3 months Nasal High-Flow (NHF) is a treatment delivering heated, humidified, and optionally oxygen-enriched air at high flow rates through a nasal cannula. The main physiologic effects of NHF are an improvement in gas exchanges including a reduction in hypercapnia, an optimization in breathing patterns with a reduction of work of breathing. Nasal High-Flow (NHF) is delivered via a comfortable nasal interface and has demonstrated good treatment adherence.
The investigators hypothesize that in COPD-related hypercapnic chronic respiratory failure with limited compliance to NIV (less than 5 hours per night), nasal High-Flow (NHF) will be non-inferior for controlling nocturnal hypoventilation and might improve daytime subjective patients centered outcomes, physical activity and nocturnal adherence to treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Non Invasive Ventilation device group | Active comparator | Device: Non Invasive Ventilation, Other: Education sessionThe patients in the NIV arm will receive treatment as in their usual care with an additional educational session of one hour for improving compliance. |
| Nasal High Flow (MyAirvo) device group | Experimental | Device: Nasal High Flow installation, Other: Training sessionThe patients in the NHF arm will receive NHF treatment and two hours training adaptation session will be conducted in the hospital. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Diagnosed with COPD (FEV1/FVC < 70%) and long term indication for home NIV for initiated at least 3 months prior the inclusion.
- Compliance with NIV (less than 5 hours and more than 1 hour) per night on average during the last 3 months prior to inclusion.
- Naïve to Nasal High Flow (NHF) therapy, i.e. having not used NHF in the last 6 months prior to inclusion.
- Able to understand, follow objectives and methods of protocol in French language.
- Patient affiliated to social security insurance or beneficiary of social health insurance.
Key exclusion criteria (8 listed)
- Significant uncontrolled cardiac disease (investigator judgment), and/or Left Ventricular Ejection Fraction (LVEF) < 45%.
- Known co-existing obstructive sleep apnea requiring expiratory pressure above 6 cmH20.
- Severe nasal obstruction, previous upper airway surgery preventing the usage of NHF, or, at the discretion of investigator, any other contraindication for using the NHF.
- Patients who are unable or unwilling to give informed consent.
- Participating in another research study.
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 |
|---|---|---|
| Nasal High Flow installationAlso: MyAirvo DeviceParticipants randomized in NHF group will receive the nasal high flow (NHF) treatment delivered by myAirvo2. Nasal High-Flow (NHF) is a treatment delivering heated, humidified, and optionally oxygen-enriched, air at high flow rates through a nasal cannula. The physiologic effects of NHF are an improvement in gas exchanges including a reduction in hypercarbia an optimization in breathing patterns with a reduction of work of breathing and high compliance as delivered via a comfortable nasal interface | Device | Nasal High Flow (MyAirvo) device group |
| Non Invasive VentilationParticipants randomized in the Non Invasive Ventilation group will receive treatment as in their usual care. | Device | Non Invasive Ventilation device group |
| Training sessionThe patients in the Nasal High Flow (MyAirvo) arm will receive two hours training adaptation session in the hospital | Other | Nasal High Flow (MyAirvo) device group |
| Education sessionParticipants randomized in the Non Invasive Ventilation group will receive an additional educational session of one hour for improving compliance. | Other | Non Invasive Ventilation device group |
Primary outcome
Changes on nocturnal parameters with the nasal high-flow (NHF) compared to non-invasive ventilation in patients with a COPD-related hypercapnic respiratory failure.
Time frame: between night at day 1 (baseline) and night at day 90 (3 months after)
Differences in mean overnight transcutaneous PtCO2 measurement
15 secondary outcomes
Evaluation the impact of nasal high-flow (NHF) on other nocturnal parameters compared to non-invasive ventilation ± LTOT compared to non-invasive ventilation in patients with a COPD-related hypercapnic respiratory failure.
Time frame: between night at day 1 (baseline) and night at day 90 (3 months after)
Treatment adherence
Time frame: between night at day 1 (baseline) and night at day 90 (3 months after)
Daytime blood gas values in ambient air
Time frame: between day 0 (inclusion) and day 97 (end of the study)
Other nocturnal parameter
Time frame: between night at day 1 (baseline) and night at day 90 (3 months after)
Physical activity
Time frame: for 7 days from the day 1 and for 7 days from the day 90
Sleep activity
Time frame: between night at day 1 (baseline) and night at day 90 (3 months after)
Sleep activity
Time frame: between night at day 1 (baseline) and night at day 90 (3 months after)
Sleep activity
Time frame: between night at day 1 (baseline) and night at day 90 (3 months after)
Pulmonary function tests
Time frame: between day 0 and day 97
Pulmonary function tests
Time frame: between day 0 and day 97
Pulmonary function tests
Time frame: between day 0 and day 97
Health related quality of life
Time frame: between day 0 and day 97
Health related quality of life
Time frame: between day 0 and day 97
Cardiovasculary function
Time frame: between day 0 and day 97
Number of participants with adverse events will be assessed in each group by interrogating patients in order to assess the safety of nasal high-flow (NHF) treatment
Time frame: between day 0 and day 97
Results and safety
The study was stopped early (reason given: lack enrollment). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 May 2022.
- Background: PubMed 31429884Biener AI, Decker SL, Rohde F. Prevalence and Treatment of Chronic Obstructive Pulmonary Disease (COPD) in the United States. JAMA. 2019 Aug 20;322(7):602. doi: 10.1001/jama.2019.10241. No abstract available.
- Background: PubMed 30806700Riley CM, Sciurba FC. Diagnosis and Outpatient Management of Chronic Obstructive Pulmonary Disease: A Review. JAMA. 2019 Feb 26;321(8):786-797. doi: 10.1001/jama.2019.0131.
- Background: PubMed 29875138Houben-Wilke S, Augustin IM, Vercoulen JH, van Ranst D, Bij de Vaate E, Wempe JB, Spruit MA, Wouters EFM, Franssen FME. COPD stands for complex obstructive pulmonary disease. Eur Respir Rev. 2018 Jun 6;27(148):180027. doi: 10.1183/16000617.0027-2018. Print 2018 Jun 30.
- Background: PubMed 30729638Suh ES, Murphy PB, Hart N. Home mechanical ventilation for chronic obstructive pulmonary disease: What next after the HOT-HMV trial? Respirology. 2019 Aug;24(8):732-739. doi: 10.1111/resp.13484. Epub 2019 Feb 7.
- Background: PubMed 26744042Crimi C, Noto A, Princi P, Cuvelier A, Masa JF, Simonds A, Elliott MW, Wijkstra P, Windisch W, Nava S. Domiciliary Non-invasive Ventilation in COPD: An International Survey of Indications and Practices. COPD. 2016 Aug;13(4):483-90. doi: 10.3109/15412555.2015.1108960. Epub 2016 Jan 8.
- Background: PubMed 25298063Kohnlein T, Windisch W, Wegscheider K, Welte T. Non-invasive positive pressure ventilation for severe COPD--Authors' reply. Lancet Respir Med. 2014 Oct;2(10):e19. doi: 10.1016/S2213-2600(14)70215-2. No abstract available.
- Background: PubMed 28424360Murphy AM, Thomas A, Crinion SJ, Kent BD, Tambuwala MM, Fabre A, Pepin JL, Roche HM, Arnaud C, Ryan S. Intermittent hypoxia in obstructive sleep apnoea mediates insulin resistance through adipose tissue inflammation. Eur Respir J. 2017 Apr 19;49(4):1601731. doi: 10.1183/13993003.01731-2016. Print 2017 Apr.
- Background: PubMed 27264777Vanfleteren LEGW, Spruit MA, Wouters EFM, Franssen FME. Management of chronic obstructive pulmonary disease beyond the lungs. Lancet Respir Med. 2016 Nov;4(11):911-924. doi: 10.1016/S2213-2600(16)00097-7. Epub 2016 Jun 2.
- Background: 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.
- Background: PubMed 24157199Struik FM, Lacasse Y, Goldstein RS, Kerstjens HA, Wijkstra PJ. Nocturnal noninvasive positive pressure ventilation in stable COPD: a systematic review and individual patient data meta-analysis. Respir Med. 2014 Feb;108(2):329-37. doi: 10.1016/j.rmed.2013.10.007. Epub 2013 Oct 14.
- Individual participant dataSharing planned: No
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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, MD PhD principal investigator
Laboratoire EFCR, CHU de Grenoble
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Nasal High Flow installation, Non Invasive Ventilation and Training session in people with Adherence, Treatment, 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 6 inclusion and 8 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 24 May 2022. 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: lack enrollment). 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?
Changes on nocturnal parameters with the nasal high-flow (NHF) compared to non-invasive ventilation in patients with a COPD-related hypercapnic respiratory failure. (time frame: between night at day 1 (baseline) and night at day 90 (3 months after)). 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 NCT04281316, which also lists 10 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 24 May 2022.