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

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ClinicalTrials.gov Identifier: NCT02545855
Recruitment Status : Completed
First Posted : September 10, 2015
Last Update Posted : April 17, 2018
Sponsor:
Collaborator:
Kobe City Medical Center General Hospital
Information provided by (Responsible Party):
Translational Research Center for Medical Innovation, Kobe, Hyogo, Japan

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.

Condition or disease Intervention/treatment Phase
Chronic Obstructive Pulmonary Disease (COPD) Device: High-flow nasal cannula therapy Device: Home oxygen therapy (HOT) Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Long-term High-flow Nasal Cannula Therapy in Patients With Stable COPD: a Prospective, Randomized Crossover Study
Actual Study Start Date : August 17, 2015
Actual Primary Completion Date : April 30, 2017
Actual Study Completion Date : April 30, 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: COPD Lung Diseases

Arm Intervention/treatment
Experimental: 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.
Device: 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.
Other Name: myAIRVO2®

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.

Experimental: 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.
Device: 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.
Other Name: myAIRVO2®

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.




Primary Outcome Measures :
  1. 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 Measures :
  1. Quality-adjusted life year (QALY) by Japanese version of the EQ-5D-5L value sets [ Time Frame: Week 0, 6, 12 and 52 ]
    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.

  2. 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 ]
  3. Changes from baseline in the modified medical research council (mMRC) scale at week 6 and 12 [ Time Frame: Week 0, 6 and 12 ]
  4. 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 ]
  5. Changes from baseline in oxygen saturation (SpO2) at week 6 and 12 [ Time Frame: Week 0, 6 and 12 ]
  6. 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 ]
  7. Changes from baseline in the pulmonary function tests at week 6 and 12 [ Time Frame: Week 0, 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).

  8. Changes from baseline in the 6-minute walk test (6MWT) scores at week 6 and 12 [ Time Frame: Week 0, 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.

  9. Changes from baseline in physical activity by the Lifecorder® at week 6 and 12 [ Time Frame: Week 0, 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.

  10. COPD exacerbation in both week 1-6 and week 7-12 [ Time Frame: Week 1-6 and week 7-12 ]
  11. Medication change [ Time Frame: Week 1-52 ]
  12. Oxygen flow rate at pre- and post-myAIRVO2® therapy in treatment period (week 1-12) [ Time Frame: Week 1-12 ]
  13. Total flow rates at pre- and post-myAIRVO2® therapy in treatment period (week 1-12) [ Time Frame: Week 1-12 ]
  14. Hours of receiving the myAIRVO2® therapy in treatment period (week 1-12) [ Time Frame: Week 1-12 ]
  15. Adverse events with an undeniable causal relationship to the myAIRVO2® therapy [ Time Frame: Week 1-52 ]

Other Outcome Measures:
  1. 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 ]
  2. Duration from initial date of continuation period (week 13-52) until the date of first COPD exacerbation [ Time Frame: Week 13-52 ]
  3. 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 ]
  4. 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 ]
  5. 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 ]
  6. 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 ]
  7. 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 ]
  8. 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 ]


Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02545855


Locations
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Japan
Kobe City Medical Center General Hospital
Kobe, Hyogo-prefecture, Japan, 650-0047
Sponsors and Collaborators
Translational Research Center for Medical Innovation, Kobe, Hyogo, Japan
Kobe City Medical Center General Hospital
Investigators
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Principal Investigator: Keisuke Tomii, MD, Ph.D. Kobe City Medical Center General Hospital
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Translational Research Center for Medical Innovation, Kobe, Hyogo, Japan
ClinicalTrials.gov Identifier: NCT02545855    
Other Study ID Numbers: TRIRES1507
UMIN000017639 ( Other Identifier: UMIN-CTR )
First Posted: September 10, 2015    Key Record Dates
Last Update Posted: April 17, 2018
Last Verified: April 2018
Keywords provided by Translational Research Center for Medical Innovation, Kobe, Hyogo, Japan:
myAIRVO2
high-flow nasal cannula therapy
home oxygen therapy
HOT
Additional relevant MeSH terms:
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Lung Diseases
Lung Diseases, Obstructive
Pulmonary Disease, Chronic Obstructive
Respiratory Tract Diseases