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 20 Years and older. Per ClinicalTrials.gov, last updated 2018-04-17.
Sponsored by Translational Research Center for Medical Innovation, Kobe, Hyogo, Japan · Not applicable, Interventional, and Treatment
This is a prospective, randomized crossover study for evaluation of the efficacy and safety of long-term nocturnal high-flow nasal cannula therapy with the myAIRVO2® in stable COPD patients with stage 2-4 of the Global Initiative for Chronic Obstructive Lung Disease (GOLD) and hypercapnia who require home oxygen therapy (HOT). The total duration of subject participation will be 52 weeks, consisting of 12-week treatment period and 40-week continuation period. Subjects who satisfy all inclusion and exclusion criteria will be randomly assigned to one of two treatment arms, Arm A (week 1-6: the myAIRVO2® therapy plus HOT, week 7-12: HOT only) or Arm B (week 1-6: HOT only, week 7-12: the myAIRVO2® therapy plus HOT). All subjects will receive nocturnal high-flow nasal cannula therapy with the myAIRVO2®, in addition to their current HOT. After treatment period, the willing subjects can continue the myAIRVO2® therapy plus HOT for week 13-52 regardless of treatment arm assignment. The end of the study is defined as the treatment period or continuation period end date of the last participant, whichever is later. Subjects will primarily be assessed by the St. George's Respiratory Questionnaire for COPD Patients (SGRQ-C) at week 0, 6, 12, 24 and 52.
3,303 studies on the registry are indexed under Lung Diseases; 355 are open to participants now.
This study's planned enrollment of 30 is below the median of 72 across 2,118 interventional studies indexed under Lung Diseases.
Browse Lung Diseases studies →Translational Research Center for Medical Innovation, Kobe, Hyogo, Japan is the lead sponsor of 55 studies on the registry; 2 are open to participants now.
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Exclusion Criteria:
Subjects will receive the myAIRVO2® therapy plus HOT for week 1-6 and HOT only for week 7-12. After treatment period (week 1-12), willing subjects can continue the myAIRVO2® therapy plus HOT for week 13-52 regardless of treatment arm assignment.
Device: High-flow nasal cannula therapy · Device: Home oxygen therapy (HOT)
Subjects will receive HOT only for week 1-6 and the myAIRVO2® therapy plus HOT for week 7-12. After treatment period (week 1-12), willing subjects can continue the myAIRVO2® therapy plus HOT for week 13-52 regardless of treatment arm assignment.
Device: High-flow nasal cannula therapy · Device: Home oxygen therapy (HOT)
All subjects will receive nocturnal high-flow nasal cannula therapy with the myAIRVO2®, in addition to their current 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 HOT which kept original usage conditions at the time of enrollment throughout the entire duration of the study regardless of treatment arm assignment.
Changes from baseline in the St. George's Respiratory Questionnaire for COPD patients (SGRQ-C) total score at week 6 and 12
Time frame: Week 0, 6 and 12
Quality-adjusted life year (QALY) by Japanese version of the EQ-5D-5L value sets
Quality-adjusted life year (QALY) of subjects will be assessed by Japanese version of the EQ-5D-5L value sets at week 6 and 12, including assessment of changes from baseline in the EQ-5D-5L utility index scores and visual analogue scale scores at week 6, 12 and 52.
Time frame: Week 0, 6, 12 and 52
Changes from baseline in symptom, activity and impact scores of the St. George's respiratory questionnaire for COPD patients (SGRQ-C) at week 6 and 12
Time frame: Week 0, 6 and 12
Changes from baseline in the modified medical research council (mMRC) scale at week 6 and 12
Time frame: Week 0, 6 and 12
Changes from baseline in potential hydrogen (pH), partial pressure of oxygen (PaO2), and partial pressure of carbon dioxide (PaCO2) of the arterial blood gas analysis at week 6 and 12
Time frame: Week 0, 6 and 12
Changes from baseline in oxygen saturation (SpO2) at week 6 and 12
Time frame: Week 0, 6 and 12
Changes from baseline in transcutaneous carbon dioxide (PtcCO2) levels and the median - 95th percentile of nocturnal transcutaneous carbon dioxide (PtcCO2) at week 6 and 12
Time frame: Week 0, 6 and 12
Changes from baseline in the pulmonary function tests at week 6 and 12
Lung function of 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, diffusion capacity to carbon monoxide (DLCO, %DLCO), residual volume (RV, %RV), functional residual capacity (FRC, %FRC) and total lung capacity (TLC, %TLC).
Time frame: Week 0, 6 and 12
Changes from baseline in the 6-minute walk test (6MWT) scores at week 6 and 12
Functional exercise capacity of subjects will be assessed by the 6MWT in the following indicators: the 6MWT distance (m), changes in pre- and post-6MWT pulse oximeter (SpO2), and post-6MWT modified borg scale.
Time frame: Week 0, 6 and 12
Changes from baseline in physical activity by the Lifecorder® at week 6 and 12
Physical activity of subjects will be assessed by the Lifecorder® in the daily average of the following indicators: energy consumption (kcal/day), step-counts (steps/d) and activity time (h/d). The indicators will be calculated by 7 days records just before each assessment day.
Time frame: Week 0, 6 and 12
COPD exacerbation in both week 1-6 and week 7-12
Time frame: Week 1-6 and week 7-12
Medication change
Time frame: Week 1-52
Oxygen flow rate at pre- and post-myAIRVO2® therapy in treatment period (week 1-12)
Time frame: Week 1-12
Total flow rates at pre- and post-myAIRVO2® therapy in treatment period (week 1-12)
Time frame: Week 1-12
Hours of receiving the myAIRVO2® therapy in treatment period (week 1-12)
Time frame: Week 1-12
Adverse events with an undeniable causal relationship to the myAIRVO2® therapy
Time frame: Week 1-52
The ratio of subjects received the myAIRVO2® therapy plus HOT at least 1 day in continuation period (week 13-52) in subjects who completed treatment period (week 1-12)
Time frame: Week 13-52
Duration from initial date of continuation period (week 13-52) until the date of first COPD exacerbation
Time frame: Week 13-52
Chronological changes of symptom, activity and impact scores of the St. George's respiratory questionnaire for COPD patients (SGRQ-C) in subjects having a full data set at week 0, 6, 12, 24 and 52
Time frame: Week 0, 6, 12, 24 and 52
Chronological changes of the modified medical research council (mMRC) scale in subjects having a full data set at week 0, 6, 12, 24 and 52
Time frame: Week 0, 6, 12, 24 and 52
Chronological changes of potential hydrogen (pH), partial pressure of oxygen (PaO2), and partial pressure of carbon dioxide (PaCO2) of the arterial blood gas analysis in subjects having a full data set at week 0, 6, 12, 24 and 52
Time frame: Week 0, 6, 12, 24 and 52
Chronological changes of oxygen saturation (SpO2) in subjects having a full data set at week 0, 6, 12, 24 and 52
Time frame: Week 0, 6, 12, 24 and 52
Chronological changes of transcutaneous carbon dioxide (PtcCO2) levels and the median - 95th percentile of nocturnal transcutaneous carbon dioxide (PtcCO2) in subjects having a full data set at week 0, 6, 12, 24 and 52
Time frame: Week 0, 6, 12, 24 and 52
Chronological changes of the pulmonary function tests in subjects having a full data set at week 0, 6, 12, 24 and 52
Time frame: Week 0, 6, 12, 24 and 52
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Translational Research Center for Medical Innovation, Kobe, Hyogo, Japan