Back to resultsRespiratory Support in Chronic Obstructive Pulmonary Disease (COPD) Patients
Primary Purpose
Chronic Obstructive Pulmonary Disease, COPD Exacerbation
Status
Recruiting
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
home ventilators
Sponsored by
About this trial
This is an interventional supportive care trial for Chronic Obstructive Pulmonary Disease focused on measuring Respiratory Support
Eligibility Criteria
Inclusion Criteria:
- 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%).
Exclusion Criteria:
- 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
- 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.
Sites / Locations
- Groupe Hospitalier Pitié Salpêtrière-Charles FoixRecruiting
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm Type
No Intervention
Active Comparator
Active Comparator
Active Comparator
Arm Label
Control group
Non-targeted home NIV
Targeted home NIV
Rescue home NIV
Arm Description
no home non-invasive ventilation (NIV), only hospital NIV
Nocturnal home non-invasive ventilation (NIV)
Nocturnal home non-invasive ventilation (NIV) with high monitoring
home non-invasive ventilation (NIV) on demand
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Overall survival
estimated using the Kaplan-Meier method
Frequency of exacerbations requiring hospitalization
The number of patients that experience one or more exacerbations resulting in hospitalisation
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;
Assessment of Exacerbation based on changes in arterial pressure of carbon dioxide
Change in arterial partial pressure of carbon dioxide (PaCO2) in mmHg
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
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.
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.
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.
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
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.
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.
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.
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
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)
Adverse events (AEs) frequency
Serious adverse events (SAEs) occurrence rate.
Full Information
NCT ID
NCT03890224
First Posted
March 15, 2019
Last Updated
July 17, 2019
Sponsor
Clinact
Collaborators
Fondation du Souffle, Assistance Publique - Hôpitaux de Paris
1. Study Identification
Unique Protocol Identification Number
NCT03890224
Brief Title
Respiratory Support in Chronic Obstructive Pulmonary Disease (COPD) Patients
Official Title
Respiratory Support in Chronic Obstructive Pulmonary Disease (COPD) Patients After Acute Exacerbation With Monitoring the Quality of Support
Study Type
Interventional
2. Study Status
Record Verification Date
March 2019
Overall Recruitment Status
Recruiting
Study Start Date
July 4, 2019 (Actual)
Primary Completion Date
March 15, 2022 (Anticipated)
Study Completion Date
December 31, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Clinact
Collaborators
Fondation du Souffle, Assistance Publique - Hôpitaux de Paris
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Obstructive Pulmonary Disease, COPD Exacerbation
Keywords
Respiratory Support
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Sequential Assignment
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)
Allocation
Randomized
Enrollment
400 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Control group
Arm Type
No Intervention
Arm Description
no home non-invasive ventilation (NIV), only hospital NIV
Arm Title
Non-targeted home NIV
Arm Type
Active Comparator
Arm Description
Nocturnal home non-invasive ventilation (NIV)
Arm Title
Targeted home NIV
Arm Type
Active Comparator
Arm Description
Nocturnal home non-invasive ventilation (NIV) with high monitoring
Arm Title
Rescue home NIV
Arm Type
Active Comparator
Arm Description
home non-invasive ventilation (NIV) on demand
Intervention Type
Device
Intervention Name(s)
home ventilators
Intervention Description
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.
Primary Outcome Measure Information:
Title
admission-free survival
Description
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.
Time Frame
0-36 months
Secondary Outcome Measure Information:
Title
Overall survival
Description
estimated using the Kaplan-Meier method
Time Frame
0-36 months
Title
Frequency of exacerbations requiring hospitalization
Description
The number of patients that experience one or more exacerbations resulting in hospitalisation
Time Frame
12 months
Title
Frequency of exacerbations resulting in physician directed treatment
Description
The number of patients that experience an exacerbation resulting in physician directed treatment, self-management or no treatment change;
Time Frame
12 months
Title
Assessment of Exacerbation based on changes in arterial pressure of carbon dioxide
Description
Change in arterial partial pressure of carbon dioxide (PaCO2) in mmHg
Time Frame
0, 1, 3, 6, 12, 18, 24, 30 and 36 months
Title
Assessment of Exacerbation based on changes in arterial partial pressure of oxygen
Description
Change in arterial partial pressure of oxygen (PaO2) severe respiratory insufficiency in mmHg
Time Frame
0, 1, 3, 6, 12, 18, 24, 30 and 36 months
Title
Assessment of Quality of life with St George's respiratory questionnaire
Description
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.
Time Frame
0,1, 3, 6, 24 and 36 months
Title
Assessment of Quality of life with Severe Respiratory Insufficiency Questionnaire
Description
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.
Time Frame
0,1, 3, 6, 24 and 36 months
Title
Assessment of Quality of life with SF-36
Description
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.
Time Frame
0,1, 3, 6, 24 and 36 months
Title
Assessment of Quality of life with the 5-level EQ-5D version
Description
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
Time Frame
0,1, 3, 6, 24 and 36 months
Title
Assessment of Quality of life with the Charlson Comorbidity Index
Description
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.
Time Frame
0,1, 3, 6, 24 and 36 months
Title
Assessment of Quality of life with the COPD Assessment Test (CAT)
Description
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.
Time Frame
0,1, 3, 6, 24 and 36 months
Title
Assessment of Quality of sleep with Pittsburgh Sleep Quality Index
Description
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.
Time Frame
0,1, 3, 6, 24 and 36 months
Title
Assessment of Quality of sleep with Epworth Sleepiness Scale
Description
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
Time Frame
0,1, 3, 6, 24 and 36 months
Title
Assessment of dyspnea with Modified Medical Research Council (mMRC) scale
Description
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)
Time Frame
0,1, 3, 6, 24 and 36 months
Title
Adverse events (AEs) frequency
Description
Serious adverse events (SAEs) occurrence rate.
Time Frame
0, 3, 6, 12, 18, 24 and 36 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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%).
Exclusion Criteria:
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
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Angèle Guilbot
Phone
+33-180-13-15-19
Email
angele.guilbot@multihealthgroup.com
First Name & Middle Initial & Last Name or Official Title & Degree
Nathalie Gagne
Phone
+33-180-13-14-70
Email
nathalie.gagne@clinact.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jesus Gonzalez, MD
Organizational Affiliation
Hôpital Pitié Salpêtrière-Charles Foix, Paris, France ,
Official's Role
Principal Investigator
Facility Information:
Facility Name
Groupe Hospitalier Pitié Salpêtrière-Charles Foix
City
Paris
State/Province
Ile-de-France
ZIP/Postal Code
75651
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jesus² GONZALES-EBERMEJO, Professor
Phone
+33 1 42 16 78 59
Email
jesus.gonzalez@aphp.fr
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
33092618
Citation
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. Erratum In: Trials. 2020 Nov 23;21(1):961.
Results Reference
derived
Learn more about this trial
Respiratory Support in Chronic Obstructive Pulmonary Disease (COPD) Patients
We'll reach out to this number within 24 hrs