Back to resultsStudy of Long-term HFNC for COPD Patients With HOT (FLOCOP)
Primary Purpose
Chronic Obstructive Pulmonary Disease (COPD)
Status
Completed
Phase
Not Applicable
Locations
Japan
Study Type
Interventional
Intervention
High-flow nasal cannula therapy
Home oxygen therapy (HOT)
Sponsored by
About this trial
This is an interventional treatment trial for Chronic Obstructive Pulmonary Disease (COPD) focused on measuring myAIRVO2, high-flow nasal cannula therapy, home oxygen therapy, HOT, COPD
Eligibility Criteria
Inclusion Criteria:
- Patients who are diagnosed with the global initiative on obstructive lung disease (GOLD) stage 2-4 COPD.
- Patients who have received nocturnal HOT 16 hours or more per day for 1 month or more at the time of the informed consent.
- Patients with PaCO2 >= 45 Torr and pH >= 7.35 at screening.
- Patients with COPD exacerbation (Moderate or Severe; judged by the investigators) within the past 1 year prior to the informed consent.
- Patients who are more than 40 years old at the time of the informed consent.
- Patients who agree to participate in the study with the written informed consent.
Exclusion Criteria:
- Patients with severe kidney, liver or cardiovascular disease.
- Patients with active malignant tumor.
- Patients with acute disease.
- Patients who are diagnosed with asthma. (Excluding COPD patients with history of asthma).
- Patients who have any history of obstructive sleep apnea syndrome (OSAS) or are highly-suspected cases in the clinical. (Excluding patients who are denied the diagnosis of OSAS by the result of overnight polysomnography.)
- Patients with diseases that affecting the efficacy endpoints (for example: active pulmonary infection, clinically significant pulmonary fibrosis and bronchiectasis, α-1-antitrypsin deficiency etc.,) and are regarded as inadequate for the study by the investigators.
- Patients who have experienced a COPD exacerbation (any Severity: judged by the investigators) within the past 4 weeks prior to the informed consent.
- Patients who are receiving nocturnal noninvasive positive pressure ventilation (NPPV), or who had been received it within 4 weeks prior to the informed consent.
- Patients who have used HFNC at home within the past 1 year prior to the informed consent, or are using any HFNC. (Excluding patients who used HFNC during hospitalization due to acute respiratory failure within 1 year prior to the informed consent.)
- Patients with history of tracheotomy, severe pharyngeal surgery or severe nasal cavity surgery within the past 6 months prior to the informed consent.
- Patients who are pregnant.
- Patients with cognitive impairment or mental disorder who are regarded as inadequate to evaluate for the study by the investigators.
- Patients who are regarded as being unable to operate the myAIRVO2 adequately at home by the investigators.
- Patients who have participated in the other study at the time of the informed consent, or will participate in the other study.
- Any other cases who are regarded as inadequate for the study enrollment by the investigators.
Sites / Locations
- Kobe City Medical Center General Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Arm A(myAIRVO2® + HOT)
Arm B(HOT)
Arm Description
Subjects receive following protocol treatment; Home oxygen therapy (HOT) plus nocturnal high-flow nasal cannula therapy with the myAIRVO2 within 52weeks.
Subjects receive following protocol treatment; Home oxygen therapy (HOT) only within 52weeks.
Outcomes
Primary Outcome Measures
Frequency (the number of occurrences per year) of COPD exacerbation (Moderate or Severe)
COPD exacerbation will be assessed by the disease diary which is kept by each patient within the term of intervention.
Secondary Outcome Measures
Term from enrollment to the date of first COPD exacerbation (Moderate or Severe)
The term from enrollment to the date of first COPD exacerbation is a duration from the start of intervention (Week0) to the date of first COPD exacerbation or death from any cause which ever comes first.
The date of first COPD exacerbation will be assessed by the disease diary which is kept by each patient within the term of intervention.
Term from enrollment to death from any cause
Term from enrollment to death from any cause is a duration from the start of intervention (Week0) to death from any cause.
Frequency (the number of occurrences per year) of COPD exacerbation (All Severity and Severe only)
COPD exacerbation will be assessed by the disease diary which is kept by each patient within the term of intervention.
Total St. George's respiratory questionnaire (SGRQ-C) score, and each components score (symptom score, activity score, and impact score)
SGRQ-C score will be assessed by Japanese version of the SGRQ-C value sets including each components score (symptom score, activity score, and impact score).
Quality-adjusted life year (QALY) by mapping the EQ-5D-5L utility scores
Quality-adjusted life year (QALY) of the subjects will be assessed by Japanese version of the EQ-5D-5L value sets including assessment of changes from baseline in the EQ-5D-5L utility index scores and visual analogue scale scores.
Total SRI (Severe Respiratory Insufficiency Questionnaire) score
Total SRI score will be assessed by Japanese version of the SRI value sets.
Total PSQI-J(Japanese version of the Pittsburgh Sleep Quality Index) score
Total PSQI-J score will be assessed by Japanese version of the PSQI value sets.
Dyspnea intensity: the modified medical research council (mMRC) score
Dyspnea intensity will be evaluated by the modified medical research council (mMRC) score.
Arterial blood gas analysis (ABG): pH, PaO2, PaCO2, HCO3-, BE
ABG will be evaluated by the blood gas analysis equipment.
Oxygen Saturation (SpO2)
SpO2 will be evaluated by Pulse Oximeter.
Pulmonary functions: FVC, FEV1, FEV1%
Lung function of the subjects will be assessed by the pulmonary function tests in the following indicators: vital capacity (VC, %VC), forced vital capacity (FVC, %FVC), forced expiratory volume in 1 second (FEV1, ％FEV1), FEV1/FVC.
6-minute walk test (6MWT)
6MWT for the respiration rehabilitation is defined as the functional exercise capacity which is assessed by the following indicators: the distance (m), changes in pre- and post-6MWT pulse oximeter (SpO2), and post-6MWT modified borg scale.
Term from enrollment to the date of long-term (more than 1month) NPPV(Noninvasive Positive Pressure Ventilation) usage
The term from the start of intervention (Week0) to the date of Long-term NPPV usage.
Long-term NPPV usage is defined as more than 1month NPPV usage.
Flow rate(Oxygen / Total) (Arm A only)
Oxygen flow rate / Total flow rate will be confirmed by the record of numerical value displayed on the device.
Total hours of myAIRVO2-use (Arm A only)
Total hours of myAIRVO2-use will be confirmed by the record of numerical value displayed on the device.
Adverse events
Adverse events will be determined by the latest version of MedDRA/J （Medical Dictionary for Regulatory Activities/J）at the time of Database lock.
Full Information
NCT ID
NCT03282019
First Posted
September 7, 2017
Last Updated
January 5, 2021
Sponsor
Translational Research Center for Medical Innovation, Kobe, Hyogo, Japan
Collaborators
Kobe City Medical Center General Hospital
1. Study Identification
Unique Protocol Identification Number
NCT03282019
Brief Title
Study of Long-term HFNC for COPD Patients With HOT
Acronym
FLOCOP
Official Title
Efficacy and Safety of Long-term High-flow Nasal Cannula Oxygen Therapy in Stable COPD Patients With Home Oxygen Therapy (HOT): a Multicenter, Prospective, Randomized Controlled Study
Study Type
Interventional
2. Study Status
Record Verification Date
January 2021
Overall Recruitment Status
Completed
Study Start Date
September 6, 2017 (Actual)
Primary Completion Date
October 28, 2020 (Actual)
Study Completion Date
October 28, 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Translational Research Center for Medical Innovation, Kobe, Hyogo, Japan
Collaborators
Kobe City Medical Center General Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
This is a prospective, randomized parallel study for evaluation of the efficacy and safety of long-term nocturnal high-flow nasal cannula therapy (HFNC: with the myAIRVO2 as HFNC in this study) in stable COPD patients with the global initiative for chronic obstructive lung disease (GOLD) stage 2-4, PaCO2 >= 45 Torr and hypercapnia who require home oxygen therapy (HOT) using COPD exacerbation (Moderate or Severe).
Detailed Description
An abroad study of the stable COPD patients was reported that HFNC usage decreased the frequency of COPD exacerbation.
In addition, the result of the pilot study (NCT02545855) of the stable COPD patient in Japan is indicated that HOT with HFNC improved their QOL and PaCO2 by comparing to HOT only.
Therefore, this study is planned to indicate the efficacy of HFNC which can increase the ventilation efficiency and have the function of heated humidification, by comparing HOT with HFNC to HOT only.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Obstructive Pulmonary Disease (COPD)
Keywords
myAIRVO2, high-flow nasal cannula therapy, home oxygen therapy, HOT, COPD
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
120 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Arm A(myAIRVO2® + HOT)
Arm Type
Experimental
Arm Description
Subjects receive following protocol treatment; Home oxygen therapy (HOT) plus nocturnal high-flow nasal cannula therapy with the myAIRVO2 within 52weeks.
Arm Title
Arm B(HOT)
Arm Type
Active Comparator
Arm Description
Subjects receive following protocol treatment; Home oxygen therapy (HOT) only within 52weeks.
Intervention Type
Device
Intervention Name(s)
High-flow nasal cannula therapy
Other Intervention Name(s)
myAIRVO2®
Intervention Description
Subjects will receive nocturnal high-flow nasal cannula therapy with the myAIRVO2®, in addition to their current Home oxygen therapy (HOT). The myAIRVO2® is used for at least 4 hours per day with flow rates in the range 30-40 L/min. The investigator can adjust the nocturnal oxygen flow rates to keep SpO2 88-92% stably. If the subjects report discomfort, the investigator can adjust the flow rates in the range at least 20 L/min.
Intervention Type
Device
Intervention Name(s)
Home oxygen therapy (HOT)
Intervention Description
All subjects will continue their current Home oxygen therapy (HOT) which kept original usage conditions at the time of enrollment throughout the entire duration of the study regardless of treatment arm assignment.
Primary Outcome Measure Information:
Title
Frequency (the number of occurrences per year) of COPD exacerbation (Moderate or Severe)
Description
COPD exacerbation will be assessed by the disease diary which is kept by each patient within the term of intervention.
Time Frame
52weeks
Secondary Outcome Measure Information:
Title
Term from enrollment to the date of first COPD exacerbation (Moderate or Severe)
Description
The term from enrollment to the date of first COPD exacerbation is a duration from the start of intervention (Week0) to the date of first COPD exacerbation or death from any cause which ever comes first.
The date of first COPD exacerbation will be assessed by the disease diary which is kept by each patient within the term of intervention.
Time Frame
up to 52 weeks
Title
Term from enrollment to death from any cause
Description
Term from enrollment to death from any cause is a duration from the start of intervention (Week0) to death from any cause.
Time Frame
up to 52 weeks
Title
Frequency (the number of occurrences per year) of COPD exacerbation (All Severity and Severe only)
Description
COPD exacerbation will be assessed by the disease diary which is kept by each patient within the term of intervention.
Time Frame
52weeks
Title
Total St. George's respiratory questionnaire (SGRQ-C) score, and each components score (symptom score, activity score, and impact score)
Description
SGRQ-C score will be assessed by Japanese version of the SGRQ-C value sets including each components score (symptom score, activity score, and impact score).
Time Frame
at 0, 12, 24 and 52 weeks
Title
Quality-adjusted life year (QALY) by mapping the EQ-5D-5L utility scores
Description
Quality-adjusted life year (QALY) of the subjects will be assessed by Japanese version of the EQ-5D-5L value sets including assessment of changes from baseline in the EQ-5D-5L utility index scores and visual analogue scale scores.
Time Frame
at 0, 12, 24 and 52 weeks
Title
Total SRI (Severe Respiratory Insufficiency Questionnaire) score
Description
Total SRI score will be assessed by Japanese version of the SRI value sets.
Time Frame
at 0, 12, 24 and 52 weeks
Title
Total PSQI-J(Japanese version of the Pittsburgh Sleep Quality Index) score
Description
Total PSQI-J score will be assessed by Japanese version of the PSQI value sets.
Time Frame
at 0, 12, 24 and 52 weeks
Title
Dyspnea intensity: the modified medical research council (mMRC) score
Description
Dyspnea intensity will be evaluated by the modified medical research council (mMRC) score.
Time Frame
52weeks
Title
Arterial blood gas analysis (ABG): pH, PaO2, PaCO2, HCO3-, BE
Description
ABG will be evaluated by the blood gas analysis equipment.
Time Frame
52weeks
Title
Oxygen Saturation (SpO2)
Description
SpO2 will be evaluated by Pulse Oximeter.
Time Frame
52weeks
Title
Pulmonary functions: FVC, FEV1, FEV1%
Description
Lung function of the subjects will be assessed by the pulmonary function tests in the following indicators: vital capacity (VC, %VC), forced vital capacity (FVC, %FVC), forced expiratory volume in 1 second (FEV1, ％FEV1), FEV1/FVC.
Time Frame
52weeks
Title
6-minute walk test (6MWT)
Description
6MWT for the respiration rehabilitation is defined as the functional exercise capacity which is assessed by the following indicators: the distance (m), changes in pre- and post-6MWT pulse oximeter (SpO2), and post-6MWT modified borg scale.
Time Frame
at 0, 12, 24 and 52 weeks
Title
Term from enrollment to the date of long-term (more than 1month) NPPV(Noninvasive Positive Pressure Ventilation) usage
Description
The term from the start of intervention (Week0) to the date of Long-term NPPV usage.
Long-term NPPV usage is defined as more than 1month NPPV usage.
Time Frame
52weeks
Title
Flow rate(Oxygen / Total) (Arm A only)
Description
Oxygen flow rate / Total flow rate will be confirmed by the record of numerical value displayed on the device.
Time Frame
52weeks
Title
Total hours of myAIRVO2-use (Arm A only)
Description
Total hours of myAIRVO2-use will be confirmed by the record of numerical value displayed on the device.
Time Frame
52weeks
Title
Adverse events
Description
Adverse events will be determined by the latest version of MedDRA/J （Medical Dictionary for Regulatory Activities/J）at the time of Database lock.
Time Frame
52weeks
Other Pre-specified Outcome Measures:
Title
Correlation between frequency of COPD exacerbation (All Severity and Severe only) and amount of ABG change
Description
Amount of ABG change will be calculated by the ABG value at before and after the intervention.
Time Frame
52weeks
Title
Correlation between frequency of COPD exacerbation (All Severity and Severe only) and amount of SpO2 change
Description
Amount of SpO2 change will be calculated by the ABG value of before and after the intervention.
Time Frame
52weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Patients who are diagnosed with the global initiative on obstructive lung disease (GOLD) stage 2-4 COPD.
Patients who have received nocturnal HOT 16 hours or more per day for 1 month or more at the time of the informed consent.
Patients with PaCO2 >= 45 Torr and pH >= 7.35 at screening.
Patients with COPD exacerbation (Moderate or Severe; judged by the investigators) within the past 1 year prior to the informed consent.
Patients who are more than 40 years old at the time of the informed consent.
Patients who agree to participate in the study with the written informed consent.
Exclusion Criteria:
Patients with severe kidney, liver or cardiovascular disease.
Patients with active malignant tumor.
Patients with acute disease.
Patients who are diagnosed with asthma. (Excluding COPD patients with history of asthma).
Patients who have any history of obstructive sleep apnea syndrome (OSAS) or are highly-suspected cases in the clinical. (Excluding patients who are denied the diagnosis of OSAS by the result of overnight polysomnography.)
Patients with diseases that affecting the efficacy endpoints (for example: active pulmonary infection, clinically significant pulmonary fibrosis and bronchiectasis, α-1-antitrypsin deficiency etc.,) and are regarded as inadequate for the study by the investigators.
Patients who have experienced a COPD exacerbation (any Severity: judged by the investigators) within the past 4 weeks prior to the informed consent.
Patients who are receiving nocturnal noninvasive positive pressure ventilation (NPPV), or who had been received it within 4 weeks prior to the informed consent.
Patients who have used HFNC at home within the past 1 year prior to the informed consent, or are using any HFNC. (Excluding patients who used HFNC during hospitalization due to acute respiratory failure within 1 year prior to the informed consent.)
Patients with history of tracheotomy, severe pharyngeal surgery or severe nasal cavity surgery within the past 6 months prior to the informed consent.
Patients who are pregnant.
Patients with cognitive impairment or mental disorder who are regarded as inadequate to evaluate for the study by the investigators.
Patients who are regarded as being unable to operate the myAIRVO2 adequately at home by the investigators.
Patients who have participated in the other study at the time of the informed consent, or will participate in the other study.
Any other cases who are regarded as inadequate for the study enrollment by the investigators.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Keisuke Tomii, MD, Ph.D.
Organizational Affiliation
Kobe City Medical Center General Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Kobe City Medical Center General Hospital
City
Kobe
State/Province
Hyogo
ZIP/Postal Code
6500047
Country
Japan
12. IPD Sharing Statement
Plan to Share IPD
Undecided
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Study of Long-term HFNC for COPD Patients With HOT
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