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

Primary Purpose

Chronic Obstructive Pulmonary Disease (COPD)

Status

Completed

Phase

Not Applicable

Locations

Japan

Study Type

Interventional

Intervention

High-flow nasal cannula therapy

Home oxygen therapy (HOT)

About this trial

This is an interventional treatment trial for Chronic Obstructive Pulmonary Disease (COPD) focused on measuring myAIRVO2, high-flow nasal cannula therapy, home oxygen therapy, HOT

Eligibility Criteria

20 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Subjects with the Global Initiative for Obstructive Lung Disease (GOLD) stage 2-4 COPD
Subjects who have received HOT for at least 16 hours per day for at least 1 month at the time of informed consent
Subjects with PaCO2 <= 60 torr, and >= 45 torr at the time of screening
Subjects who have signed written informed consent to participate in this study

Exclusion Criteria:

Subjects with severe kidney, liver or cardiovascular disease
Subjects with active malignant tumor
Subjects with acute disease (i.e., acute myocardial infarction)
Subjects with a history of obstructive sleep apnea syndrome
Subjects with complications affecting efficacy endpoints and who are regarded by the investigator as inadequate for this study
Subjects who had experienced COPD exacerbation within the past 6 weeks prior to informed consent
Subjects who have been receiving nocturnal noninvasive positive pressure ventilation (NPPV) or had been received within the past 6 weeks prior to informed consent
Subjects with a history of tracheotomy or severe pharyngeal nasal cavity surgery within the past 6 months
Pregnant women
Subjects with cognitive impairment or mental disorder and who are regarded by the investigator as inadequate to be evaluated in this study
Subjects who are regarded by the investigator as being unable to operate the myAIRVO2 adequately at home
Subjects who are participating or wil participate in the another clinical trial at the time of informed consent
Any other cases who are regarded by the investigator as inadequate for enrollment

Sites / Locations

Kobe City Medical Center General Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Arm Label

Arm A (myAIRVO2® + HOT, HOT)

Arm B (HOT, myAIRVO2® + HOT)

Arm 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.

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.

Outcomes

Primary Outcome Measures

Changes from baseline in the St. George's Respiratory Questionnaire for COPD patients (SGRQ-C) total score at week 6 and 12

Secondary Outcome Measures

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.

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

Changes from baseline in the modified medical research council (mMRC) scale at week 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

Changes from baseline in oxygen saturation (SpO2) at week 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

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).

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.

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.

COPD exacerbation in both week 1-6 and week 7-12

Medication change

Oxygen flow rate at pre- and post-myAIRVO2® therapy in treatment period (week 1-12)

Total flow rates at pre- and post-myAIRVO2® therapy in treatment period (week 1-12)

Hours of receiving the myAIRVO2® therapy in treatment period (week 1-12)

Adverse events with an undeniable causal relationship to the myAIRVO2® therapy

Full Information

NCT ID

NCT02545855

First Posted

September 1, 2015

Last Updated

April 16, 2018

Sponsor

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

Collaborators

Kobe City Medical Center General Hospital

1. Study Identification

Unique Protocol Identification Number

NCT02545855

Brief Title

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

Official Title

Long-term High-flow Nasal Cannula Therapy in Patients With Stable COPD: a Prospective, Randomized Crossover Study

Study Type

Interventional

2. Study Status

Record Verification Date

April 2018

Overall Recruitment Status

Completed

Study Start Date

August 17, 2015 (Actual)

Primary Completion Date

April 30, 2017 (Actual)

Study Completion Date

April 30, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

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

Collaborators

Kobe City Medical Center General Hospital

4. Oversight

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Chronic Obstructive Pulmonary Disease (COPD)

Keywords

myAIRVO2, high-flow nasal cannula therapy, home oxygen therapy, HOT

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Crossover Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

30 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Arm A (myAIRVO2® + HOT, HOT)

Arm Type

Experimental

Arm Description

Arm Title

Arm B (HOT, myAIRVO2® + HOT)

Arm Type

Experimental

Arm Description

Intervention Type

Device

Intervention Name(s)

High-flow nasal cannula therapy

Other Intervention Name(s)

myAIRVO2®

Intervention Description

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

Intervention Name(s)

Home oxygen therapy (HOT)

Intervention Description

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 Outcome Measure Information:

Title

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 Outcome Measure Information:

Title

Quality-adjusted life year (QALY) by Japanese version of the EQ-5D-5L value sets

Description

Time Frame

Week 0, 6, 12 and 52

Title

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

Title

Changes from baseline in the modified medical research council (mMRC) scale at week 6 and 12

Time Frame

Week 0, 6 and 12

Title

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

Title

Changes from baseline in oxygen saturation (SpO2) at week 6 and 12

Time Frame

Week 0, 6 and 12

Title

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

Title

Changes from baseline in the pulmonary function tests at week 6 and 12

Description

Time Frame

Week 0, 6 and 12

Title

Changes from baseline in the 6-minute walk test (6MWT) scores at week 6 and 12

Description

Time Frame

Week 0, 6 and 12

Title

Changes from baseline in physical activity by the Lifecorder® at week 6 and 12

Description

Time Frame

Week 0, 6 and 12

Title

COPD exacerbation in both week 1-6 and week 7-12

Time Frame

Week 1-6 and week 7-12

Title

Medication change

Time Frame

Week 1-52

Title

Oxygen flow rate at pre- and post-myAIRVO2® therapy in treatment period (week 1-12)

Time Frame

Week 1-12

Title

Total flow rates at pre- and post-myAIRVO2® therapy in treatment period (week 1-12)

Time Frame

Week 1-12

Title

Hours of receiving the myAIRVO2® therapy in treatment period (week 1-12)

Time Frame

Week 1-12

Title

Adverse events with an undeniable causal relationship to the myAIRVO2® therapy

Time Frame

Week 1-52

Other Pre-specified Outcome Measures:

Title

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)

Time Frame

Week 13-52

Title

Duration from initial date of continuation period (week 13-52) until the date of first COPD exacerbation

Time Frame

Week 13-52

Title

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

Time Frame

Week 0, 6, 12, 24 and 52

Title

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

Time Frame

Week 0, 6, 12, 24 and 52

Title

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

Time Frame

Week 0, 6, 12, 24 and 52

Title

Chronological changes of oxygen saturation (SpO2) in subjects having a full data set at week 0, 6, 12, 24 and 52

Time Frame

Week 0, 6, 12, 24 and 52

Title

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

Time Frame

Week 0, 6, 12, 24 and 52

Title

Chronological changes of the pulmonary function tests in subjects having a full data set at week 0, 6, 12, 24 and 52

Time Frame

Week 0, 6, 12, 24 and 52

10. Eligibility

Sex

All

Minimum Age & Unit of Time

20 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Subjects with the Global Initiative for Obstructive Lung Disease (GOLD) stage 2-4 COPD Subjects who have received HOT for at least 16 hours per day for at least 1 month at the time of informed consent Subjects with PaCO2 <= 60 torr, and >= 45 torr at the time of screening Subjects who have signed written informed consent to participate in this study Exclusion Criteria: Subjects with severe kidney, liver or cardiovascular disease Subjects with active malignant tumor Subjects with acute disease (i.e., acute myocardial infarction) Subjects with a history of obstructive sleep apnea syndrome Subjects with complications affecting efficacy endpoints and who are regarded by the investigator as inadequate for this study Subjects who had experienced COPD exacerbation within the past 6 weeks prior to informed consent Subjects who have been receiving nocturnal noninvasive positive pressure ventilation (NPPV) or had been received within the past 6 weeks prior to informed consent Subjects with a history of tracheotomy or severe pharyngeal nasal cavity surgery within the past 6 months Pregnant women Subjects with cognitive impairment or mental disorder and who are regarded by the investigator as inadequate to be evaluated in this study Subjects who are regarded by the investigator as being unable to operate the myAIRVO2 adequately at home Subjects who are participating or wil participate in the another clinical trial at the time of informed consent Any other cases who are regarded by the investigator as inadequate for enrollment

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Keisuke Tomii, MD, Ph.D.

Organizational Affiliation

Kobe City Medical Center General Hospital

Official's Role

Principal Investigator

Facility Information:

Facility Name

Kobe City Medical Center General Hospital

City

Kobe

State/Province

Hyogo-prefecture

ZIP/Postal Code

650-0047

Country

Japan

12. IPD Sharing Statement

Citations:

PubMed Identifier

29283682

Citation

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.

Results Reference

derived

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

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