Chronic Obstructive Pulmonary DiseaseNCT03890224
Respiratory Support in Chronic Obstructive Pulmonary Disease (COPD) Patients
A study testing home ventilators in people with Chronic Obstructive Pulmonary Disease and COPD Exacerbation, run by Clinact at 1 site in France.
Trial summary
The hypothesis of this study is that any of 3 modalities of home non- invasive ventilation (NIV) compared to 'no NIV' (=hospital NIV) will reduce re-admission to hospital or death in COPD patients who remain persistently hypercapnic following an exacerbation requiring NIV. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Obstructive Pulmonary Disease, COPD Exacerbation
- What is being tested?
- home ventilators
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 400 participants
- Where
- 1 siteFrance
- Study dates
- 4 Jul 2019to 28 Feb 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 1) Patients with COPD, GOLD C or D and Forced expiratory volume in one second (FEV1)<65%;
- 2) AHRF (pH<7,35 and PaCO2≥45mm Hg (≥6kPa) treated more than 24h with Ventilation (non-invasive or invasive);
- 3) 48h to 2 weeks with pH>7.35, and PaCO2>45 (>6kPa) after NIV withdrawal, during daytime at rest without oxygen or ventilatory support (or with O2 if patients are not able to avoid O2 with immediate desaturation below 80%).
Who cannot join
- Patient treated with chronic NIV or continuous positive airway pressure (CPAP) device, with ongoing treatment;
- Primary diagnosis of restrictive lung disease causing hypercapnia i.e. obesity hypoventilation and chest wall disease, however these patients will be included if the "FEV1/Forced vital capacity (FVC)" ratio is <60% and the FEV1 <50% if the predominant defect is considered to be obstructive by the center clinician;
- BMI > 35 kg/m2;
- Sedative medication causing hypercapnia (> 3 drugs or more than 20mg of morphine/day);
- Polygraphic diagnosis of Obstructive Sleep Apnoea Syndrome (AHI>30/h (French criteria);
- Cognitive impairment that would prevent informed consent into the trial
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- Pregnancy;
- Tobacco use < 10 pack-year;
- Psychiatric disease necessitating anti-psychotic medication, ongoing treatment for drug or alcohol addiction, persons of no fixed abode post-discharge;
- Unstable coronary artery syndrome;
- Age <18 years;
- Inability to comply with the protocol;
- Expected survival<12 months due to any situation other than COPD disease;
- Duration of ICU stay>10 days;
- No affiliated to national health insurance;
- Measure of legal protection (guardianship, wardship or judicial protection) for patients over the age of majority.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site, 1 recruiting
- Recruiting
Groupe Hospitalier Pitié Salpêtrière-Charles Foix
Paris, Île-de-France Region, 75651
Jesus² GONZALES-EBERMEJO, Professor, +33 1 42 16 78 59, jesus.gonzalez@aphp.fr
About this study
Official title: Respiratory Support in Chronic Obstructive Pulmonary Disease (COPD) Patients After Acute Exacerbation With Monitoring the Quality of Support
The hypothesis of this study is that any of 3 modalities of home non- invasive ventilation (NIV) compared to 'no NIV' (=hospital NIV) will reduce re-admission to hospital or death in COPD patients who remain persistently hypercapnic following an exacerbation requiring NIV.
Read the detailed description
By 2020, chronic obstructive pulmonary disease (COPD) is expected to be the 3rd leading cause of death in the world, especially in countries of middle to high income, like EU. Despite the improvements in survival by using acute non- invasive ventilation (NIV) to treat patients with exacerbations of COPD complicated by acute hypercapnic respiratory failure (AHRF), these patients are at high risk of re-admission and further life-threatening events. Furthermore, in a recent study of 110 patients who had AHRF (RESCUE study, Struik, Thorax 2014), at one year after discharge 65% had another life-threatening event, and 49% had died. New recent data suggests that NIV at home can reduce re-admissions (HMV-LTOT, Murphy, JAMA 2017), but in a small proportion of patients, and with a high level of expertise. There is an urgent need to develop strategies to reduce the number and severity of exacerbations of COPD. With healthcare objectives and budget constraints, telemonitoring of COPD patients is an important challenge in most European countries. RESCUE2-Monitor is the next step. This European trial (currently, France, Spain and Portugal) will test the hypothesis that home NIV, with a highly adapted ventilatory strategy (hereafter referred to as 'TARGETED VENTILATION'), compared to no home NIV (only hospital NIV), to non-targeted home NIV or to rescue home NIV will reduce re-admission to hospital or death in COPD patients, is possible using e-medicine, and will reduce costs of health.
- Being tested
- home ventilators
- Keywords
- Respiratory Support
- 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.
home ventilatorsDevice
The 3 test treatments are home non-targeted NIV, home targeted NIV and rescue home NIV. COPD patients will be equipped with home ventilators and fitted with either nasal, oronasal or facial masks. All the ventilators used will be CE marked.
| Study group | Role | What they receive |
|---|---|---|
| Control group | No intervention | no home non-invasive ventilation (NIV), only hospital NIV |
| Non-targeted home NIV | Active comparator | Nocturnal home non-invasive ventilation (NIV) Receives: Device: home ventilators |
| Targeted home NIV | Active comparator | Nocturnal home non-invasive ventilation (NIV) with high monitoring Receives: Device: home ventilators |
| Rescue home NIV | Active comparator | home non-invasive ventilation (NIV) on demand Receives: Device: home ventilators |
What is being measured
The primary outcome is the main question the study is designed to answer.
admission-free survival
defined as time from randomisation to hospital admission in relation with severe exacerbation of COPD or death from any cause, whichever event occurred first, estimated using the Kaplan-Meier method. If neither event occurs, then time will be taken from day randomisation to the last known follow up visit. If withdrawal occurs prior to death, time will be taken from the day of randomisation to day of withdrawal.
Measured: 0-36 months
Secondary outcomes (15)
Overall survival
estimated using the Kaplan-Meier method
Measured: 0-36 months
Frequency of exacerbations requiring hospitalization
The number of patients that experience one or more exacerbations resulting in hospitalisation
Measured: 12 months
Frequency of exacerbations resulting in physician directed treatment
The number of patients that experience an exacerbation resulting in physician directed treatment, self-management or no treatment change;
Measured: 12 months
Assessment of Exacerbation based on changes in arterial pressure of carbon dioxide
Change in arterial partial pressure of carbon dioxide (PaCO2) in mmHg
Measured: 0, 1, 3, 6, 12, 18, 24, 30 and 36 months
Assessment of Exacerbation based on changes in arterial partial pressure of oxygen
Change in arterial partial pressure of oxygen (PaO2) severe respiratory insufficiency in mmHg
Measured: 0, 1, 3, 6, 12, 18, 24, 30 and 36 months
Assessment of Quality of life with St George's respiratory questionnaire
Evolution of scores obtained at the St George's respiratory questionnaire. Scores are expressed as a percentage of overall impairment where 100 represents worst possible health status and 0 indicates best possible health status.
Measured: 0,1, 3, 6, 24 and 36 months
Assessment of Quality of life with Severe Respiratory Insufficiency Questionnaire
Evolution of scores obtained at the Severe Respiratory Insufficiency Questionnaire The SRI consists of seven subscales covering 49 items: Respiratory Complaints (SRI-RC), Physical Functioning (SRI-PF), Attendant Symptoms and Sleep (SRI-AS), Social Relationships (SRI-SR), Anxiety (SRI-AX), Psychological Well-Being (SRI-WB), and Social Functioning (SRI-SF). These seven subscales can be summarised to one Summary Scale (SRI-SS). All items relate to the patients' circumstances of the last week. Rating for each item is provided by a five-point Likert-scale, a scaling method which measures either positive or negative responses to a given statement with five possible grading steps ranging from "strongly agree" to "strongly disagree". Higher scores are attributed to better Health Related Quality of life.
Measured: 0,1, 3, 6, 24 and 36 months
Assessment of Quality of life with SF-36
Evolution of scores obtained at SF-36 questionnaire. The Short Form (36) Health Survey is a 36-item, patient-reported survey of patient health. The lower the score the more disability. The higher the score the less disability i.e., a score of zero is equivalent to maximum disability and a score of 100 is equivalent to no disability.
Measured: 0,1, 3, 6, 24 and 36 months
Assessment of Quality of life with the 5-level EQ-5D version
Evolution of scores obtained at the EQ5D5L, a standardised measure of health status developed by the EuroQol Group in order to provide a simple, generic measure of health for clinical and economic appraisal1
Measured: 0,1, 3, 6, 24 and 36 months
Assessment of Quality of life with the Charlson Comorbidity Index
Evolution of the Charlson Comorbidity Index, a method of categorizing comorbidities of patients based on the International Classification of Diseases (ICD). A score of zero indicates that no comorbidities were found. The higher the score, the more likely the predicted outcome will result in mortality or higher resource use.
Measured: 0,1, 3, 6, 24 and 36 months
Assessment of Quality of life with the COPD Assessment Test (CAT)
Evolution of the CAT score. The COPD Assessment Test (CAT) is a questionnaire for people with COPD. It is designed to measure the impact of COPD on a person's life, and how this changes over time.
Measured: 0,1, 3, 6, 24 and 36 months
Assessment of Quality of sleep with Pittsburgh Sleep Quality Index
Evolution of the Pittsburgh Sleep Quality Index. The Pittsburgh Sleep Quality Index (PSQI) is a self-report questionnaire that assesses sleep quality over a 1-month time interval. The measure consists of 19 individual items, creating 7 components that produce one global score. Each item is weighted on a 0-3 interval scale. The global PSQI score is then calculated by totaling the seven component scores, providing an overall score ranging from 0 to 21, where lower scores denote a healthier sleep quality.
Measured: 0,1, 3, 6, 24 and 36 months
Assessment of Quality of sleep with Epworth Sleepiness Scale
Evolution of the score of Epworth Sleepiness Scale. The questionnaire asks the subject to rate his or her probability of falling asleep on a scale of increasing probability from 0 to 3 for eight different situations that most people engage in during their daily lives, though not necessarily every day. The scores for the eight questions are added together to obtain a single number. A number in the 0-9 range is considered to be normal while a number in the 10-24 range indicates that expert medical advice should be sought
Measured: 0,1, 3, 6, 24 and 36 months
Assessment of dyspnea with Modified Medical Research Council (mMRC) scale
Evolution of the mMRC score. Dyspnea in daily living was evaluated by the mMRC scale which consists in five statements that describe almost the entire range of dyspnea from none (Grade 0) to almost complete incapacity (Grade 4)
Measured: 0,1, 3, 6, 24 and 36 months
Adverse events (AEs) frequency
Serious adverse events (SAEs) occurrence rate.
Measured: 0, 3, 6, 12, 18, 24 and 36 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Mar 2019
- Study start4 Jul 2019
- Primary completion15 Jun 2024 (estimated)
- Study completion28 Feb 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Sequential
- Model description
- Rescue2-monitor is an open-label, prospective randomized, controlled, superiority clinical trial, performed in patients with hypercapnic chronic obstructive pulmonary disease post-acute hypercapnic exacerbation. Four arms (distributed between groups at a ratio of 1:1:1:1) will be compared: no home NIV 'hospital NIV' (control group) versus any of 3 modalities of home NIV (experimental groups). The 3 experimental treatments are Nocturnal home NIV 'non-targeted home NIV', Nocturnal home NIV with high monitoring 'targeted home NIV', and 'rescue home NIV'.
- Masking
- None (open label)
- Enrolment
- 400 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Clinact
- Sponsor type
- University, hospital or other
- Collaborators
- Assistance Publique - Hôpitaux de Paris, Fondation du Souffle
- Responsible party
- Sponsor
- Investigators
- Jesus Gonzalez, MD, Principal investigator, Hôpital Pitié Salpêtrière-Charles Foix, Paris, France ,
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03890224
- Sponsor's protocol ID
- R2M
- Other IDs
- 2018-A01872-53
- Status last verified
- Jun 2024
- First submitted
- 15 Mar 2019
- Last updated
- 20 Jun 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Rescue2-monitor group. Respiratory support in COPD patients after acute exacerbation with monitoring the quality of support (Rescue2-monitor): an open-label, prospective randomized, controlled, superiority clinical trial comparing hospital- versus home-based acute non-invasive ventilation for patients with hypercapnic chronic obstructive pulmonary disease. Trials. 2020 Oct 22;21(1):877. doi: 10.1186/s13063-020-04672-w.
PubMed 33092618
Study at a glance
From the registry record, last updated by the sponsor on 20 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Respiratory Support in Chronic Obstructive Pulmonary Disease (COPD) Patients After Acute Exacerbation With Monitoring the Quality of Support
- ClinicalTrials.gov ID
- NCT03890224
- Acronym / sponsor ID
- R2M
- Keywords
- Respiratory Support
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 400 participants (estimated)
- Lead sponsor
- ClinactUniversity, hospital or other
- Collaborators
- Assistance Publique - Hôpitaux de Paris, Fondation du Souffle
- Study start
- 4 Jul 2019 (actual)
- Primary completion
- 15 Jun 2024 (estimated)
- Study completion
- 28 Feb 2027 (estimated)
- First posted
- 26 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.
The hypothesis of this study is that any of 3 modalities of home non- invasive ventilation (NIV) compared to 'no NIV' (=hospital NIV) will reduce re-admission to hospital or death in COPD patients who remain persistently hypercapnic following an exacerbation requiring NIV.
Detailed description
By 2020, chronic obstructive pulmonary disease (COPD) is expected to be the 3rd leading cause of death in the world, especially in countries of middle to high income, like EU. Despite the improvements in survival by using acute non- invasive ventilation (NIV) to treat patients with exacerbations of COPD complicated by acute hypercapnic respiratory failure (AHRF), these patients are at high risk of re-admission and further life-threatening events. Furthermore, in a recent study of 110 patients who had AHRF (RESCUE study, Struik, Thorax 2014), at one year after discharge 65% had another life-threatening event, and 49% had died. New recent data suggests that NIV at home can reduce re-admissions (HMV-LTOT, Murphy, JAMA 2017), but in a small proportion of patients, and with a high level of expertise. There is an urgent need to develop strategies to reduce the number and severity of exacerbations of COPD. With healthcare objectives and budget constraints, telemonitoring of COPD patients is an important challenge in most European countries. RESCUE2-Monitor is the next step. This European trial (currently, France, Spain and Portugal) will test the hypothesis that home NIV, with a highly adapted ventilatory strategy (hereafter referred to as 'TARGETED VENTILATION'), compared to no home NIV (only hospital NIV), to non-targeted home NIV or to rescue home NIV will reduce re-admission to hospital or death in COPD patients, is possible using e-medicine, and will reduce costs of health.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 4
- Model description
- Rescue2-monitor is an open-label, prospective randomized, controlled, superiority clinical trial, performed in patients with hypercapnic chronic obstructive pulmonary disease post-acute hypercapnic exacerbation. Four arms (distributed between groups at a ratio of 1:1:1:1) will be compared: no home NIV 'hospital NIV' (control group) versus any of 3 modalities of home NIV (experimental groups). The 3 experimental treatments are Nocturnal home NIV 'non-targeted home NIV', Nocturnal home NIV with high monitoring 'targeted home NIV', and 'rescue home NIV'.
| Arm | Type | Receives |
|---|---|---|
| Control group | No intervention | –no home non-invasive ventilation (NIV), only hospital NIV |
| Non-targeted home NIV | Active comparator | Device: home ventilatorsNocturnal home non-invasive ventilation (NIV) |
| Targeted home NIV | Active comparator | Device: home ventilatorsNocturnal home non-invasive ventilation (NIV) with high monitoring |
| Rescue home NIV | Active comparator | Device: home ventilatorshome non-invasive ventilation (NIV) on demand |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 1) Patients with COPD, GOLD C or D and Forced expiratory volume in one second (FEV1)<65%;
- 2) AHRF (pH<7,35 and PaCO2≥45mm Hg (≥6kPa) treated more than 24h with Ventilation (non-invasive or invasive);
- 3) 48h to 2 weeks with pH>7.35, and PaCO2>45 (>6kPa) after NIV withdrawal, during daytime at rest without oxygen or ventilatory support (or with O2 if patients are not able to avoid O2 with immediate desaturation below 80%).
Key exclusion criteria (16 listed)
- Patient treated with chronic NIV or continuous positive airway pressure (CPAP) device, with ongoing treatment;
- Primary diagnosis of restrictive lung disease causing hypercapnia i.e. obesity hypoventilation and chest wall disease, however these patients will be included if the "FEV1/Forced vital capacity (FVC)" ratio is <60% and the FEV1 <50% if the predominant defect is considered to be obstructive by the center clinician;
- BMI > 35 kg/m2;
- Sedative medication causing hypercapnia (> 3 drugs or more than 20mg of morphine/day);
- Polygraphic diagnosis of Obstructive Sleep Apnoea Syndrome (AHI>30/h (French criteria);
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 |
|---|---|---|
| home ventilatorsThe 3 test treatments are home non-targeted NIV, home targeted NIV and rescue home NIV. COPD patients will be equipped with home ventilators and fitted with either nasal, oronasal or facial masks. All the ventilators used will be CE marked. | Device | Non-targeted home NIV, Rescue home NIV, Targeted home NIV |
Primary outcome
admission-free survival
Time frame: 0-36 months
defined as time from randomisation to hospital admission in relation with severe exacerbation of COPD or death from any cause, whichever event occurred first, estimated using the Kaplan-Meier method. If neither event occurs, then time will be taken from day randomisation to the last known follow up visit. If withdrawal occurs prior to death, time will be taken from the day of randomisation to day of withdrawal.
15 secondary outcomes
Overall survival
Time frame: 0-36 months
Frequency of exacerbations requiring hospitalization
Time frame: 12 months
Frequency of exacerbations resulting in physician directed treatment
Time frame: 12 months
Assessment of Exacerbation based on changes in arterial pressure of carbon dioxide
Time frame: 0, 1, 3, 6, 12, 18, 24, 30 and 36 months
Assessment of Exacerbation based on changes in arterial partial pressure of oxygen
Time frame: 0, 1, 3, 6, 12, 18, 24, 30 and 36 months
Assessment of Quality of life with St George's respiratory questionnaire
Time frame: 0,1, 3, 6, 24 and 36 months
Assessment of Quality of life with Severe Respiratory Insufficiency Questionnaire
Time frame: 0,1, 3, 6, 24 and 36 months
Assessment of Quality of life with SF-36
Time frame: 0,1, 3, 6, 24 and 36 months
Assessment of Quality of life with the 5-level EQ-5D version
Time frame: 0,1, 3, 6, 24 and 36 months
Assessment of Quality of life with the Charlson Comorbidity Index
Time frame: 0,1, 3, 6, 24 and 36 months
Assessment of Quality of life with the COPD Assessment Test (CAT)
Time frame: 0,1, 3, 6, 24 and 36 months
Assessment of Quality of sleep with Pittsburgh Sleep Quality Index
Time frame: 0,1, 3, 6, 24 and 36 months
Assessment of Quality of sleep with Epworth Sleepiness Scale
Time frame: 0,1, 3, 6, 24 and 36 months
Assessment of dyspnea with Modified Medical Research Council (mMRC) scale
Time frame: 0,1, 3, 6, 24 and 36 months
Adverse events (AEs) frequency
Time frame: 0, 3, 6, 12, 18, 24 and 36 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jun 2024.
- Derived from this study: PubMed 33092618Rescue2-monitor group. Respiratory support in COPD patients after acute exacerbation with monitoring the quality of support (Rescue2-monitor): an open-label, prospective randomized, controlled, superiority clinical trial comparing hospital- versus home-based acute non-invasive ventilation for patients with hypercapnic chronic obstructive pulmonary disease. Trials. 2020 Oct 22;21(1):877. doi: 10.1186/s13063-020-04672-w.
- 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.
Jesus Gonzalez, MD principal investigator
Hôpital Pitié Salpêtrière-Charles Foix, Paris, 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 home ventilators in people with Chronic Obstructive Pulmonary Disease and COPD Exacerbation, run by Clinact 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 16 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: looking for participants now, as of the sponsor's last update on 20 Jun 2024. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Angèle Guilbot (+33-180-13-15-19, angele.guilbot@multihealthgroup.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
admission-free survival (time frame: 0-36 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 NCT03890224, which also lists 1 linked publication.
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 20 Jun 2024.