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Completed

NCT Number: NCT02545855

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

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.

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Key information

Conditions

Chronic Obstructive Pulmonary Disease (COPD) Chronic Disease Disease Attributes Lung Diseases Lung Diseases, Obstructive Pathologic Processes Pathological Conditions, Signs and Symptoms Pulmonary Disease, Chronic Obstructive Respiratory Tract Diseases

Age range

20 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Kobe City Medical Center General Hospital

Kobe, Hyōgo, 650-0047, Japan

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

High-flow nasal cannula therapy

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.

Other names: myAIRVO2®

Home oxygen therapy (HOT)

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.

Primary outcomes

  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 outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

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

Other

Collaborators

  • Kobe City Medical Center General Hospital

Registry information

Official study title

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

Important dates

Study start
2015
Primary completion
2017
Study completion
2017
First posted
Sep 10, 2015
Registry last updated
Apr 17, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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