Chronic Obstructive Pulmonary Disease (COPD)
Conditions
Interventions
Arm A (1-12 weeks): The treatment cycle is 6 weeks and is continued for up to 2 cycles (12 weeks). Subjects receive HOT plus nocturnal high-flow nasal cannula therapy with the myAIRVO2 for the 1st cy
s current treatment at starting the study.
Arm B (1-12 weeks): The treatment cycle is 6 weeks and is continued for up to 2 cycles (12 weeks). Subjects receive HOT only with the myAIRVO2 for the 1st c
s current treatment at starting the study.
Continuation period (13-52 weeks): If subjects wish, HOT plus the myAIRVO2 is continued for total up to 52 weeks after the 2nd cycle.
Sponsors
Kobe City Medical Center General Hospital Department of Respiratory Medicine
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Patients who are diagnosed with the global initiative on obstructive lung disease (GOLD) stage 2-4 COPD. 2. Patients who have received nocturnal HOT 16 hours or more per day for 1 month or more at the time of the informed consent. 3. Patients with PaCO2 <= 60 torr and >= 45 torr at screening. 4. Patients who agree to participate in the study with the written informed consent.
Exclusion criteria
Exclusion criteria: 1. Patients with severe kidney, liver or cardiovascular disease. 2. Patients with active malignant tumor. 3. Patients with acute disease. 4. Patients with any history of obstructive sleep apnea syndrome. 5. Patients with diseases affecting the efficacy endpoints who are regarded as inadequate for the study by the investigators. 6. Patients who have experienced a COPD exacerbation within the past 6 weeks prior to the informed consent. 7. Patients who have received nocturnal noninvasive positive pressure ventilation (NPPV), or had received it within 6 weeks prior to the informed consent. 8. Patients with history of tracheotomy, severe pharyngeal surgery or severe nasal cavity surgery within the last 6 months. 9. Patients who are pregnant. 10. Patients with cognitive impairment or mental disorder who are regarded as inadequate to evaluate for the study by the investigators. 11. Patients who are regarded as being unable to operate the myAIRVO2 inadequately at home by the investigators. 12. Patients who have participated in the other study at the time of the informed consent, or will participate in the other study. 13. Any other cases who are regarded as inadequate for the study enrollment by the investigators.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. Total St. George's respiratory questionnaire (SGRQ-C) score. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Quality-adjusted life year (QALY) by mapping the EQ-5D-5L utility scores 2. SGRQ-C: symptom score, activity score, impact score 3. Dyspnea intensity: the modified medical research council (mMRC) score 4. Arterial blood gas analysis (ABG): pH, PaO2, PaCO2 5. Oxygen Saturation (SpO2) 6. Nocturnal PtcCO2: median and 95th percentile 7. Pulmonary functions: VC, FVC, FEV1, FEV1/FVC, DLCO, RV, FRC, TLC 8. 6 minutes walk test (6MWT): 6- minute walk test distance, SpO2, modified borg scale (mBS) 9. Physical activity: calorie consumption, step-counts, activity time 10. Hospitalization for exacerbation 11. Medication change 12. Oxygen flow rate 13. Total flow rate 14. Adverse events | — |
Countries
Japan
Contacts
Public ContactKazuma Nagata
Kobe City Medical Center General Hospital Department of Respiratory Medicine
Outcome results
None listed