Chronic Obstructive Pulmonary Disease (COPD)
Conditions
Keywords
myAIRVO2, high-flow nasal cannula therapy, home oxygen therapy, HOT
Brief summary
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.
Interventions
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.
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.
Sponsors
Kobe City Medical Center General Hospital
Translational Research Center for Medical Innovation, Kobe, Hyogo, Japan
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
20 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Subjects with the Global Initiative for Obstructive Lung Disease (GOLD) stage 2-4 COPD 2. Subjects who have received HOT for at least 16 hours per day for at least 1 month at the time of informed consent 3. Subjects with PaCO2 \<= 60 torr, and \>= 45 torr at the time of screening 4. Subjects who have signed written informed consent to participate in this study
Exclusion criteria
1. Subjects with severe kidney, liver or cardiovascular disease 2. Subjects with active malignant tumor 3. Subjects with acute disease (i.e., acute myocardial infarction) 4. Subjects with a history of obstructive sleep apnea syndrome 5. Subjects with complications affecting efficacy endpoints and who are regarded by the investigator as inadequate for this study 6. Subjects who had experienced COPD exacerbation within the past 6 weeks prior to informed consent 7. Subjects who have been receiving nocturnal noninvasive positive pressure ventilation (NPPV) or had been received within the past 6 weeks prior to informed consent 8. Subjects with a history of tracheotomy or severe pharyngeal nasal cavity surgery within the past 6 months 9. Pregnant women 10. Subjects with cognitive impairment or mental disorder and who are regarded by the investigator as inadequate to be evaluated in this study 11. Subjects who are regarded by the investigator as being unable to operate the myAIRVO2 adequately at home 12. Subjects who are participating or wil participate in the another clinical trial at the time of informed consent 13. Any other cases who are regarded by the investigator as inadequate for enrollment
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Changes from baseline in the St. George's Respiratory Questionnaire for COPD patients (SGRQ-C) total score at week 6 and 12 | Week 0, 6 and 12 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Changes from baseline in oxygen saturation (SpO2) at week 6 and 12 | Week 0, 6 and 12 | — |
| Changes from baseline in the 6-minute walk test (6MWT) scores at week 6 and 12 | Week 0, 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. |
| Changes from baseline in physical activity by the Lifecorder® at week 6 and 12 | Week 0, 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. |
| COPD exacerbation in both week 1-6 and week 7-12 | Week 1-6 and week 7-12 | — |
| Medication change | Week 1-52 | — |
| Oxygen flow rate at pre- and post-myAIRVO2® therapy in treatment period (week 1-12) | Week 1-12 | — |
| Total flow rates at pre- and post-myAIRVO2® therapy in treatment period (week 1-12) | Week 1-12 | — |
| Hours of receiving the myAIRVO2® therapy in treatment period (week 1-12) | Week 1-12 | — |
| Adverse events with an undeniable causal relationship to the myAIRVO2® therapy | Week 1-52 | — |
| Quality-adjusted life year (QALY) by Japanese version of the EQ-5D-5L value sets | Week 0, 6, 12 and 52 | 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. |
| 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 | Week 0, 6 and 12 | — |
| Changes from baseline in the modified medical research council (mMRC) scale at week 6 and 12 | 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 | 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 | Week 0, 6 and 12 | — |
| Changes from baseline in the pulmonary function tests at week 6 and 12 | Week 0, 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). |
Other
| Measure | Time frame |
|---|---|
| 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 | 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 | 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 | 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 | 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 | 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 | Week 0, 6, 12, 24 and 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) | Week 13-52 |
| Duration from initial date of continuation period (week 13-52) until the date of first COPD exacerbation | Week 13-52 |
Countries
Japan
Outcome results
None listed