Overview

This trial is active, not recruiting.

Condition chronic obstructive pulmonary disease (copd)
Treatments high-flow nasal cannula therapy, home oxygen therapy (hot)
Sponsor Translational Research Informatics Center, Kobe, Hyogo, Japan
Collaborator Kobe City Medical Center General Hospital
Start date July 2015
End date July 2017
Trial size 30 participants
Trial identifier NCT02545855, TRIRES1507, UMIN000017639

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model crossover assignment
Masking open label
Primary purpose treatment
Arm
(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.
high-flow nasal cannula therapy myAIRVO2®
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.
home oxygen therapy (hot)
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.
(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.
high-flow nasal cannula therapy myAIRVO2®
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.
home oxygen therapy (hot)
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.

Primary Outcomes

Measure
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

Secondary Outcomes

Measure
Quality-adjusted life year (QALY) by Japanese version of the EQ-5D-5L value sets
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
time frame: Week 0, 6 and 12
Changes from baseline in the 6-minute walk test (6MWT) scores at week 6 and 12
time frame: Week 0, 6 and 12
Changes from baseline in physical activity by the Lifecorder® at week 6 and 12
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

Eligibility Criteria

Male or female participants at least 20 years old.

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

Additional Information

Official title Long-term High-flow Nasal Cannula Therapy in Patients With Stable COPD: a Prospective, Randomized Crossover Study
Principal investigator Keisuke Tomii, MD, Ph.D.
Trial information was received from ClinicalTrials.gov and was last updated in July 2016.
Information provided to ClinicalTrials.gov by Translational Research Informatics Center, Kobe, Hyogo, Japan.