Chronic Obstructive Pulmonary DiseasePPR-NHFNCT03882372
Nasal High Flow to Maintain the Benefits of Pulmonary Rehabilitation in Chronic Obstructive Pulmonary Disease Patients
A study testing Nasal high flow in people with Chronic Obstructive Pulmonary Disease, run by ADIR Association at 1 site in France.
Trial summary
Chronic obstructive pulmonary disease (COPD) is a major cause of disability and mortality worldwide. This systemic disease progressively leads to dyspnea and exercise capacity impairment. Pulmonary rehabilitation effectively improves exercise capacity, dyspnea and quality of life in patients with COPD. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Chronic Obstructive Pulmonary Disease
- What is being tested?
- Nasal high flow
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2 participants
- Where
- 1 siteFrance
- Study dates
- 22 Jul 2019to 1 Sep 2023
- 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
- Chronic obstructive pulmonary disease stage III to IV;
- With or without long-term oxygen therapy;
- Having completed a course of pulmonary rehabilitation within the last 4 weeks (at least 18 sessions).
Who cannot join
- Did not complete a course of pulmonary rehabilitation;
- Using noninvasive ventilation or constant positive airway pressure treatment;
- Tracheostomy;
- Nasal high flow intolerance;
- Pregnancy or likely to be;
- Unable to consent;
- Patients under guardianship.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Nasal High Flow to Maintain the Benefits of Pulmonary Rehabilitation in Patients With Severe to Very Severe Chronic Obstructive Pulmonary Disease - A Randomized Controlled Study
Chronic obstructive pulmonary disease (COPD) is a major cause of disability and mortality worldwide. This systemic disease progressively leads to dyspnea and exercise capacity impairment. Pulmonary rehabilitation effectively improves exercise capacity, dyspnea and quality of life in patients with COPD. However, its benefits progressively fade over time due to several factors such as the lack of regular exercise activity, dyspnea, airway secretions, hematosis impairment and acute exacerbations which can lead to hospitalization and accelerated muscle wasting.
Nasal high flow (NHF) is a support used to deliver heated and humidified high flow air (up to 60 L/min) through nasal canula providing promising physiological benefits such as positive airway pressure or upper airway carbon dioxide washout. It can be used in association with oxygen and offers the advantage to overtake the patient's inspiratory flow, providing a stable inspired fraction of oxygen. Nasal high flow has widely been studied in pediatric and adult intensive care units and seems better than conventional oxygen therapy and as effective as noninvasive ventilation with regards to mortality to treat hypoxemic acute respiratory failure.
Read more
More recently, several studies have shown that long-term nasal high flow could contribute to improve exercise capacity, dyspnea, airway secretion removal, hematosis, reduced acute exacerbations and subsequent hospitalizations in patients with COPD.
Based on these results, the primary aim of this study is to assess whether long-term nasal high flow treatment can help COPD patients to better maintain their endurance capacity following a course of pulmonary rehabilitation.
Read the detailed description
Experimental design:
Patients achieving their last pulmonary rehabilitation session will be approached to participate in this study.
Eligible patients who agree to participate in the study and sign informed consent will perform two baseline visit assessments:
First visit: Incremental cardiopulmonary exercise testing. Second visit: Other baseline assessment (see outcome section), including a constant workload exercise testing at 75% of the maximal workload achieved during the incremental exercise testing.
Then, patients will then be randomized to one of the following two arms:
- Nasal high flow,
- Usual care.
After 6 months, patients will be invited to perform the same assessment as during the second baseline visit.
- Conditions
- Chronic Obstructive Pulmonary Disease
- Being tested
- Nasal high flow
- Keywords
- Chronic obstructive pulmonary disease, Pulmonary rehabilitation, Nasal high flow
- 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.
Nasal high flowDevice
See arm description.
| Study group | Role | What they receive |
|---|---|---|
| Nasal high flow | Experimental | Following baseline assessment, patients randomized to the nasal high flow arm will be equipped with a nasal high flow device (myAIRVO2) administrated through the Optiflow nasal canula. Flow will be set at the highest flow tolerated (20-30 L/min): initially 30 L/min, progressively decrease if not tolerated. Temperature will be set between 34-37°C according to the tolerance : initially 37°C and decreased if not tolerated. Patients will be asked to use the device 8h per day.
Patients under long-term oxygen will preserve their usual flow. The usual prescribed oxygen flow will then be titrated during nasal high flow to maintain the same baseline transcutaneous oxygen saturation as their conventional oxygen therapy (≥ 90%) to prevent any oxygen dilution effect of nasal high flow. Receives: Device: Nasal high flow |
| Usual care | No intervention | Patient randomized to the control group will have no other specific intervention than their usual care. Patients under long-term oxygen will preserve their usual flow. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Endurance capacity
Patients will perform a constant workload exercise testing at 75% of the maximal workload achieved during the incremental cardiopulmonary exercise testing.
Measured: The endurance capacity will be assessed at baseline
Endurance capacity
Patients will perform a constant workload exercise testing at 75% of the maximal workload achieved during the incremental cardiopulmonary exercise testing.
Measured: The endurance capacity will be assessed post-intervention (after 6months)
Secondary outcomes (29)
Quality of life: Saint George's Respiratory Questionnaire
Quality of life will be assessed using the Saint George's Respiratory Questionnaire. The score range from 0 (worst quality of life) to 100 (optimal quality of life).
Measured: The quality of life will be assessed at baseline
Quality of life: Saint George's Respiratory Questionnaire
Quality of life will be assessed using the Saint George's Respiratory Questionnaire. The score range from 0 (worst quality of life) to 100 (optimal quality of life).
Measured: The quality of life will be assessed at post-intervention (after 6months)
Quality of life: Chronic Obstructive Pulmonary Disease Assessement Test
Quality of life will be assessed using the Chronic Obstructive Pulmonary Disease Assessement Test
Measured: The quality of life will be assessed at baseline and post-intervention for a total time frame of 6month
Quality of life: Chronic Obstructive Pulmonary Disease Assessement Test
Quality of life will be assessed using the Chronic Obstructive Pulmonary Disease Assessement Test
Measured: The quality of life will be assessed post-intervention (after 6months)
Exacerbations
The number of chronic obstructive pulmonary disease self reported exacerbations experienced by the participants during the 6 months period of follow-up will be assessed.
Measured: The number of exacerbations will be assessed for a total time frame of 6month
Hospitalizations
The number of chronic obstructive pulmonary disease related hospitalizations experienced by the participants during the 6 months period of follow-up will be assessed.
Measured: The number of hospitalizations will be assessed for a total time frame of 6month
Muscle function (1) : quadriceps muscle (rectus femoris) cross-sectional area
The quadriceps muscle thickness will be assessed using echographies.
Measured: The quadriceps muscle thickness will be assessed at baseline
Muscle function (1) : quadriceps muscle (rectus femoris) cross-sectional area
The quadriceps muscle thickness will be assessed using echographies.
Measured: The quadriceps muscle thickness will be assessed at baseline and post-intervention for a total time frame of 6month
Muscle function (2) : bioimpedance
The overall muscle function will be assessed using bioimpedance (free fat mass minus total body water)
Measured: The overall muscle function using bioimpedance will be assessed post-intervention (after 6months)
Exercise capacity
Exercise capacity will be assessed using the six minutes walk test distance.
Measured: The distance performed during the six-minute walk test will be assessed at baseline
Exercise capacity
Exercise capacity will be assessed using the six minutes walk test distance.
Measured: The distance performed during the six-minute walk test will be assessed post-intervention (after 6months)
Respiratory muscle function (1) : maximal inspiratory pressure
Measured: Maximal inspiratory pressure will be assessed at baseline
Respiratory muscle function (1) : maximal inspiratory pressure
Measured: Maximal inspiratory pressure will be assessed post-intervention (after 6months)
Respiratory muscle function (2) : maximal expiratory pressure
Measured: Maximal expiratory pressure will be assessed at baseline
Respiratory muscle function (2) : maximal expiratory pressure
Measured: Maximal expiratory pressure will be assessed post-intervention (after 6months)
Respiratory muscle function (3) : sniff test
Measured: Sniff test will be assessed at baseline
Respiratory muscle function (3) : sniff test
Measured: Sniff test will be assessed post-intervention (after 6months)
Parasternal electromyogram
Parasternal electromyogram will be used to assess central output during maximal inspiratory and expiratory pressure measurement as during the sniff test. Moreover, parasternal electromyogram will be assessed both at rest and during nasal high flow (30L/min, 34°C).
Measured: Parasternal electromyogram will be assessed at baseline
Parasternal electromyogram
Parasternal electromyogram will be used to assess central output during maximal inspiratory and expiratory pressure measurement as during the sniff test. Moreover, parasternal electromyogram will be assessed both at rest and during nasal high flow (30L/min, 34°C).
Measured: Parasternal electromyogram will be assessed post-intervention (after 6months)
Physical activity (1) : steps per day
The number of steps per day will be recorded over a course of 14 week days using an activity monitor.
Measured: Steps per day will be assessed during 14 days following inclusion
Physical activity (1) : steps per day
The number of steps per day will be recorded over a course of 14 week days using an activity monitor.
Measured: Steps per day will be assessed during 14 days after 6months of intervention
Physical activity (2) : time spent during activities superior to 3 metabolic equivalent per day
The time spent during activities superior to 3 metabolic equivalent per day will be over a course of 14 week days
Measured: The time spent during activities superior to 3 metabolic equivalent per day will be assessed 14 days following inclusion
Physical activity (2) : time spent during activities superior to 3 metabolic equivalent per day
The time spent during activities superior to 3 metabolic equivalent per day will be over a course of 14 week days
Measured: The time spent during activities superior to 3 metabolic equivalent per day will be assessed during 14 days after 6months of intervention
Quality of sleep (1) : Visual Analogue Scale
The quality of sleep will be assessed using a aVisual Analogue Scale (ranging from 0 to 10 with 10 indicating higher sleep quality).
Measured: The quality of sleep using a Visual Analogue Scale will be assessed at baseline
Quality of sleep (1) : Visual Analogue Scale
The quality of sleep will be assessed using a aVisual Analogue Scale (ranging from 0 to 10 with 10 indicating higher sleep quality).
Measured: The quality of sleep using a Visual Analogue Scale will be assessed post-intervention (after 6months)
Quality of sleep (2) : pittsburgh scale
The quality of sleep will be assessed using the pittsburgh scale which has been validated to assess sleep quality. The scale range from 0 (major sleep difficulties) to 21 (no difficulty).
Measured: The quality of sleep using the pittsburgh scale will be assessed at baseline
Quality of sleep (2) : pittsburgh scale
The quality of sleep will be assessed using the pittsburgh scale which has been validated to assess sleep quality. The scale range from 0 (major sleep difficulties) to 21 (no difficulty).
Measured: The quality of sleep using the pittsburgh scale will be assessed post-intervention (after 6months)
Adherence to treatment : days of utilization during the follow-up
The data will be retrieved from the nasal high flow device
Measured: The number of days that the nasal high flow device was used throughout the follow-up will be assessed post-intervention in the nasal high flow arm for a total time frame of 6 months
Adherence to treatment : hours of utilization per day
The data will be retrieved from the nasal high flow device
Measured: The number of hours of utilization per day throughout the follow-up will be assessed post-intervention in the nasal high flow arm for a total time frame of 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Mar 2019
- Study start22 Jul 2019
- Primary completion1 Sep 2023
- Study completion1 Sep 2023
Why it stopped: Recruitment failure
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Obstructive Pulmonary DiseaseStudies 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
- Model description
- Single blind randomized study.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 2 participants (actual)
Sponsor and investigators
- Lead sponsor
- ADIR Association
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Antoine Cuvelier, MD, PhD, Prof, Principal investigator, Normandie University, UNIROUEN, UPRES EA 3830, Haute Normandie Research and Biomedical Innovation, Rouen, France ; Pulmonary, Thoracic Oncology and Respiratory Intensive Care Department, Rouen University Hospital, Rouen, FranceJean-François Muir, MD, Prof, Study chair, ADIR Association, Rouen University Hospital, Rouen, France ; Normandie University, UNIROUEN, UPRES EA 3830, Haute Normandie Research and Biomedical Innovation, Rouen, FranceMaxime Patout, MD, Msc, Study chair, Normandie University, UNIROUEN, UPRES EA 3830, Haute Normandie Research and Biomedical Innovation, Rouen, France ; Pulmonary, Thoracic Oncology and Respiratory Intensive Care Department, Rouen University Hospital, Rouen, FranceTristan Bonnevie, Msc, Study chair, ADIR Association, Rouen University Hospital, Rouen, France ; Normandie University, UNIROUEN, UPRES EA 3830, Haute Normandie Research and Biomedical Innovation, Rouen, FranceFrancis-Edouard Gravier, Msc, Study chair, ADIR Association, Rouen University Hospital, Rouen, France ; Normandie University, UNIROUEN, UPRES EA 3830, Haute Normandie Research and Biomedical Innovation, Rouen, France ; Pulmonary, Thoracic Oncology and Respiratory I
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03882372
- Sponsor's protocol ID
- PPR-NHF
- Acronym
- PPR-NHF
- Status last verified
- Nov 2023
- First submitted
- 18 Mar 2019
- Last updated
- 15 Nov 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Nasal High Flow to Maintain the Benefits of Pulmonary Rehabilitation in Patients With Severe to Very Severe Chronic Obstructive Pulmonary Disease - A Randomized Controlled Study
- ClinicalTrials.gov ID
- NCT03882372
- Acronym / sponsor ID
- PPR-NHF / PPR-NHF
- Conditions
- Chronic Obstructive Pulmonary Disease
- Keywords
- Chronic obstructive pulmonary disease, Pulmonary rehabilitation, Nasal high flow
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Recruitment failure
- Enrolment
- 2 participants (actual)
- Lead sponsor
- ADIR AssociationUniversity, hospital or other
- Study start
- 22 Jul 2019 (actual)
- Primary completion
- 1 Sep 2023 (actual)
- Study completion
- 1 Sep 2023 (actual)
- First posted
- 20 Mar 2019 (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.
Chronic obstructive pulmonary disease (COPD) is a major cause of disability and mortality worldwide. This systemic disease progressively leads to dyspnea and exercise capacity impairment. Pulmonary rehabilitation effectively improves exercise capacity, dyspnea and quality of life in patients with COPD. However, its benefits progressively fade over time due to several factors such as the lack of regular exercise activity, dyspnea, airway secretions, hematosis impairment and acute exacerbations which can lead to hospitalization and accelerated muscle wasting.
Nasal high flow (NHF) is a support used to deliver heated and humidified high flow air (up to 60 L/min) through nasal canula providing promising physiological benefits such as positive airway pressure or upper airway carbon dioxide washout. It can be used in association with oxygen and offers the advantage to overtake the patient's inspiratory flow, providing a stable inspired fraction of oxygen. Nasal high flow has widely been studied in pediatric and adult intensive care units and seems better than conventional oxygen therapy and as effective as noninvasive ventilation with regards to mortality to treat hypoxemic acute respiratory failure.
More recently, several studies have shown that long-term nasal high flow could contribute to improve exercise capacity, dyspnea, airway secretion removal, hematosis, reduced acute exacerbations and subsequent hospitalizations in patients with COPD.
Based on these results, the primary aim of this study is to assess whether long-term nasal high flow treatment can help COPD patients to better maintain their endurance capacity following a course of pulmonary rehabilitation.
Detailed description
Experimental design:
Patients achieving their last pulmonary rehabilitation session will be approached to participate in this study.
Eligible patients who agree to participate in the study and sign informed consent will perform two baseline visit assessments:
First visit: Incremental cardiopulmonary exercise testing. Second visit: Other baseline assessment (see outcome section), including a constant workload exercise testing at 75% of the maximal workload achieved during the incremental exercise testing.
Then, patients will then be randomized to one of the following two arms:
- Nasal high flow,
- Usual care.
After 6 months, patients will be invited to perform the same assessment as during the second baseline visit.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Single blind randomized study.
| Arm | Type | Receives |
|---|---|---|
| Nasal high flow | Experimental | Device: Nasal high flowFollowing baseline assessment, patients randomized to the nasal high flow arm will be equipped with a nasal high flow device (myAIRVO2) administrated through the Optiflow nasal canula. Flow will be set at the highest flow tolerated (20-30 L/min): initially 30 L/min, progressively decrease if not tolerated. Temperature will be set between 34-37°C according to the tolerance : initially 37°C and decreased if not tolerated. Patients will be asked to use the device 8h per day. Patients under long-term oxygen will preserve their usual flow. The usual prescribed oxygen flow will then be titrated during nasal high flow to maintain the same baseline transcutaneous oxygen saturation as their conventional oxygen therapy (≥ 90%) to prevent any oxygen dilution effect of nasal high flow. |
| Usual care | No intervention | –Patient randomized to the control group will have no other specific intervention than their usual care. Patients under long-term oxygen will preserve their usual flow. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Chronic obstructive pulmonary disease stage III to IV;
- With or without long-term oxygen therapy;
- Having completed a course of pulmonary rehabilitation within the last 4 weeks (at least 18 sessions).
Key exclusion criteria (7 listed)
- Did not complete a course of pulmonary rehabilitation;
- Using noninvasive ventilation or constant positive airway pressure treatment;
- Tracheostomy;
- Nasal high flow intolerance;
- Pregnancy or likely to be;
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 flowSee arm description. | Device | Nasal high flow |
Primary outcome
Endurance capacity
Time frame: The endurance capacity will be assessed at baseline
Patients will perform a constant workload exercise testing at 75% of the maximal workload achieved during the incremental cardiopulmonary exercise testing.
Endurance capacity
Time frame: The endurance capacity will be assessed post-intervention (after 6months)
Patients will perform a constant workload exercise testing at 75% of the maximal workload achieved during the incremental cardiopulmonary exercise testing.
29 secondary outcomes
Quality of life: Saint George's Respiratory Questionnaire
Time frame: The quality of life will be assessed at baseline
Quality of life: Saint George's Respiratory Questionnaire
Time frame: The quality of life will be assessed at post-intervention (after 6months)
Quality of life: Chronic Obstructive Pulmonary Disease Assessement Test
Time frame: The quality of life will be assessed at baseline and post-intervention for a total time frame of 6month
Quality of life: Chronic Obstructive Pulmonary Disease Assessement Test
Time frame: The quality of life will be assessed post-intervention (after 6months)
Exacerbations
Time frame: The number of exacerbations will be assessed for a total time frame of 6month
Hospitalizations
Time frame: The number of hospitalizations will be assessed for a total time frame of 6month
Muscle function (1) : quadriceps muscle (rectus femoris) cross-sectional area
Time frame: The quadriceps muscle thickness will be assessed at baseline
Muscle function (1) : quadriceps muscle (rectus femoris) cross-sectional area
Time frame: The quadriceps muscle thickness will be assessed at baseline and post-intervention for a total time frame of 6month
Muscle function (2) : bioimpedance
Time frame: The overall muscle function using bioimpedance will be assessed post-intervention (after 6months)
Exercise capacity
Time frame: The distance performed during the six-minute walk test will be assessed at baseline
Exercise capacity
Time frame: The distance performed during the six-minute walk test will be assessed post-intervention (after 6months)
Respiratory muscle function (1) : maximal inspiratory pressure
Time frame: Maximal inspiratory pressure will be assessed at baseline
Respiratory muscle function (1) : maximal inspiratory pressure
Time frame: Maximal inspiratory pressure will be assessed post-intervention (after 6months)
Respiratory muscle function (2) : maximal expiratory pressure
Time frame: Maximal expiratory pressure will be assessed at baseline
Respiratory muscle function (2) : maximal expiratory pressure
Time frame: Maximal expiratory pressure will be assessed post-intervention (after 6months)
Respiratory muscle function (3) : sniff test
Time frame: Sniff test will be assessed at baseline
Respiratory muscle function (3) : sniff test
Time frame: Sniff test will be assessed post-intervention (after 6months)
Parasternal electromyogram
Time frame: Parasternal electromyogram will be assessed at baseline
Parasternal electromyogram
Time frame: Parasternal electromyogram will be assessed post-intervention (after 6months)
Physical activity (1) : steps per day
Time frame: Steps per day will be assessed during 14 days following inclusion
Physical activity (1) : steps per day
Time frame: Steps per day will be assessed during 14 days after 6months of intervention
Physical activity (2) : time spent during activities superior to 3 metabolic equivalent per day
Time frame: The time spent during activities superior to 3 metabolic equivalent per day will be assessed 14 days following inclusion
Physical activity (2) : time spent during activities superior to 3 metabolic equivalent per day
Time frame: The time spent during activities superior to 3 metabolic equivalent per day will be assessed during 14 days after 6months of intervention
Quality of sleep (1) : Visual Analogue Scale
Time frame: The quality of sleep using a Visual Analogue Scale will be assessed at baseline
Quality of sleep (1) : Visual Analogue Scale
Time frame: The quality of sleep using a Visual Analogue Scale will be assessed post-intervention (after 6months)
Quality of sleep (2) : pittsburgh scale
Time frame: The quality of sleep using the pittsburgh scale will be assessed at baseline
Quality of sleep (2) : pittsburgh scale
Time frame: The quality of sleep using the pittsburgh scale will be assessed post-intervention (after 6months)
Adherence to treatment : days of utilization during the follow-up
Time frame: The number of days that the nasal high flow device was used throughout the follow-up will be assessed post-intervention in the nasal high flow arm for a total time frame of 6 months
Adherence to treatment : hours of utilization per day
Time frame: The number of hours of utilization per day throughout the follow-up will be assessed post-intervention in the nasal high flow arm for a total time frame of 6 months
Results and safety
The study was stopped early (reason given: Recruitment failure). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Nov 2023.
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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.
Antoine Cuvelier, MD, PhD, Prof principal investigator
Normandie University, UNIROUEN, UPRES EA 3830, Haute Normandie Research and Biomedical Innovation, Rouen, France ; Pulmonary, Thoracic Oncology and Respiratory Intensive Care Department, Rouen University Hospital, Rouen, France
Jean-François Muir, MD, Prof study chair
ADIR Association, Rouen University Hospital, Rouen, France ; Normandie University, UNIROUEN, UPRES EA 3830, Haute Normandie Research and Biomedical Innovation, Rouen, France
Maxime Patout, MD, Msc study chair
Normandie University, UNIROUEN, UPRES EA 3830, Haute Normandie Research and Biomedical Innovation, Rouen, France ; Pulmonary, Thoracic Oncology and Respiratory Intensive Care Department, Rouen University Hospital, Rouen, France
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 in people with Chronic Obstructive Pulmonary Disease, run by ADIR Association 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 3 inclusion and 7 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 15 Nov 2023. 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: Recruitment failure). 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?
Endurance capacity (time frame: The endurance capacity will be assessed at baseline). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 15 Nov 2023.