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| ID | Type | Description | Link |
|---|---|---|---|
| UMIN000017639 | Other Identifier | UMIN-CTR |
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| Name | Class |
|---|---|
| Kobe City Medical Center General Hospital | UNKNOWN |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm A (myAIRVO2® + HOT, HOT) | Experimental | 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. |
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| Arm B (HOT, myAIRVO2® + HOT) | Experimental | 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| High-flow nasal cannula therapy | Device | 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. |
| Measure | Description | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Week 0, 6, 12 and 52 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Keisuke Tomii, MD, Ph.D. | Kobe City Medical Center General Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Kobe City Medical Center General Hospital | Kobe | Hyōgo | 650-0047 | Japan |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 29283682 | Derived | Nagata K, Kikuchi T, Horie T, Shiraki A, Kitajima T, Kadowaki T, Tokioka F, Chohnabayashi N, Watanabe A, Sato S, Tomii K. Domiciliary High-Flow Nasal Cannula Oxygen Therapy for Patients with Stable Hypercapnic Chronic Obstructive Pulmonary Disease. A Multicenter Randomized Crossover Trial. Ann Am Thorac Soc. 2018 Apr;15(4):432-439. doi: 10.1513/AnnalsATS.201706-425OC. |
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| ID | Term |
|---|---|
| D029424 | Pulmonary Disease, Chronic Obstructive |
| ID | Term |
|---|---|
| D008173 | Lung Diseases, Obstructive |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D002908 | Chronic Disease |
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| Home oxygen therapy (HOT) | Device | 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. |
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| 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 oxygen saturation (SpO2) 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 | 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). | 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. | 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. | Week 0, 6 and 12 |
| 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 |
| 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 | 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 |
| D020969 |
| Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |