An interventional study of High-flow nasal cannula therapy and Home oxygen therapy (HOT) in Chronic Obstructive Pulmonary Disease (COPD), sponsored by Translational Research Center for Medical Innovation, Kobe, Hyogo, Japan. Completed at 1 site in Japan. Open to participants aged 40 Years and older. Per ClinicalTrials.gov, last updated 2024-11-20.
Sponsored by Translational Research Center for Medical Innovation, Kobe, Hyogo, Japan · Not applicable, Interventional, and Treatment
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).
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.
Exclusion Criteria:
Subjects receive following protocol treatment; Home oxygen therapy (HOT) plus nocturnal high-flow nasal cannula therapy with the myAIRVO2 within 52weeks.
Device: High-flow nasal cannula therapy · Device: Home oxygen therapy (HOT)
Subjects receive following protocol treatment; Home oxygen therapy (HOT) only within 52weeks.
Device: Home oxygen therapy (HOT)
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.
Also known as: myAIRVO2®
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.
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.
Time frame: 52weeks
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.
Time frame: up to 52 weeks
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.
Time frame: up to 52 weeks
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.
Time frame: 52weeks
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).
Time frame: at 0, 12, 24 and 52 weeks
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.
Time frame: at 0, 12, 24 and 52 weeks
Total SRI (Severe Respiratory Insufficiency Questionnaire) score
Total SRI score will be assessed by Japanese version of the SRI value sets.
Time frame: at 0, 12, 24 and 52 weeks
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.
Time frame: at 0, 12, 24 and 52 weeks
Dyspnea intensity: the modified medical research council (mMRC) score
Dyspnea intensity will be evaluated by the modified medical research council (mMRC) score.
Time frame: 52weeks
Arterial blood gas analysis (ABG): pH, PaO2, PaCO2, HCO3-, BE
ABG will be evaluated by the blood gas analysis equipment.
Time frame: 52weeks
Oxygen Saturation (SpO2)
SpO2 will be evaluated by Pulse Oximeter.
Time frame: 52weeks
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.
Time frame: 52weeks
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.
Time frame: at 0, 12, 24 and 52 weeks
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.
Time frame: 52weeks
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.
Time frame: 52weeks
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.
Time frame: 52weeks
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.
Time frame: 52weeks
Correlation between frequency of COPD exacerbation (All Severity and Severe only) and amount of ABG change
Amount of ABG change will be calculated by the ABG value at before and after the intervention.
Time frame: 52weeks
Correlation between frequency of COPD exacerbation (All Severity and Severe only) and amount of SpO2 change
Amount of SpO2 change will be calculated by the ABG value of before and after the intervention.
Time frame: 52weeks
Plan to share: Undecided
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Translational Research Center for Medical Innovation, Kobe, Hyogo, Japan