High-flow Nasal Cannula Therapy for Stable Chronic Obstructive Pulmonary Disease (COPD)

Translational Research Center for Medical Innovation, Kobe, Hyogo, Japan

Status: Completed

Conditions: Chronic Obstructive Pulmonary Disease (COPD)

Treatments: Device: Home oxygen therapy (HOT); Device: High-flow nasal cannula therapy

Study type: Interventional

Funder types: Other

Identifiers

NCT02545855

UMIN000017639 (Other Identifier)

TRIRES1507

Details and patient eligibility

About

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.

Enrollment: 30 estimated patients

Sex: All

Ages: 20+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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30 participants in 2 patient groups

Arm A (myAIRVO2® + HOT, HOT)

Experimental group

Description:

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.

Treatment:

Device: High-flow nasal cannula therapy

Device: Home oxygen therapy (HOT)

Arm B (HOT, myAIRVO2® + HOT)

Experimental group

Description:

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.

Treatment:

Device: High-flow nasal cannula therapy

Device: Home oxygen therapy (HOT)