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

NCT ID: NCT02545855

Last Updated: 2018-04-17

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-08-17
• Study Completion Date: 2017-04-30

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.

Conditions

Chronic Obstructive Pulmonary Disease (COPD)

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Arm A (myAIRVO2® + HOT, HOT)

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.

Group Type: EXPERIMENTAL

High-flow nasal cannula therapy

Intervention Type: 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.

Home oxygen therapy (HOT)

Intervention Type: 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.

Arm B (HOT, myAIRVO2® + HOT)

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.

Group Type: EXPERIMENTAL

High-flow nasal cannula therapy

Intervention Type: 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.

Home oxygen therapy (HOT)

Intervention Type: 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.

Interventions

High-flow nasal cannula therapy

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.

Intervention Type: DEVICE

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.

Intervention Type: DEVICE

Other Intervention Names

myAIRVO2®

Eligibility Criteria

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

• Minimum Eligible Age: 20 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Kobe City Medical Center General Hospital

UNKNOWN

Sponsor Role: collaborator

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

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Keisuke Tomii, MD, Ph.D.

Role: PRINCIPAL_INVESTIGATOR

Kobe City Medical Center General Hospital

Locations

Kobe City Medical Center General Hospital

Kobe, Hyōgo, Japan

Countries

Japan

References

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.

Reference Type: DERIVED

PMID: 29283682 (View on PubMed)

Other Identifiers

UMIN000017639

Identifier Type: OTHER

Identifier Source: secondary_id

TRIRES1507

Identifier Type: -

Identifier Source: org_study_id