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Chronic Obstructive Pulmonary Disease (COPD)NCT02545855

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

A study testing High-flow nasal cannula therapy and Home oxygen therapy (HOT) in people with Chronic Obstructive Pulmonary Disease (COPD), run by Translational Research Center for Medical Innovation, Kobe, Hyogo, Japan at 1 site in Japan.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 20 years and older
What is being tested?
High-flow nasal cannula therapy and Home oxygen therapy (HOT)
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
30 participants
Where
1 siteJapan
Study dates
17 Aug 2015to 30 Apr 2017
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 20 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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
Show all 13Show fewer
  • 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

Trial locations and contacts

1 site in 1 country.

Japan1 site

  • Kobe City Medical Center General Hospital

    Kobe, Hyōgo, 650-0047

Other trials in Japan

About this study

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

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.

Being tested
High-flow nasal cannula therapy, Home oxygen therapy (HOT)
Keywords
myAIRVO2, high-flow nasal cannula therapy, home oxygen therapy, HOT
Medical subject headings
Pulmonary Disease, Chronic Obstructive

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • High-flow nasal cannula therapyDevice

    Also called myAIRVO2®

    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)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.

Study groups in NCT02545855
Study groupRoleWhat they receive
Arm A (myAIRVO2® + HOT, HOT)ExperimentalSubjects 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.
Receives: Device: High-flow nasal cannula therapy; Device: Home oxygen therapy (HOT)
Arm B (HOT, myAIRVO2® + HOT)ExperimentalSubjects 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.
Receives: Device: High-flow nasal cannula therapy; Device: Home oxygen therapy (HOT)

What is being measured

The primary outcome is the main question the study is designed to answer.

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

    Measured: Week 0, 6 and 12

Secondary outcomes (15)

  1. 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.

    Measured: Week 0, 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

    Measured: Week 0, 6 and 12

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

    Measured: 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

    Measured: Week 0, 6 and 12

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

    Measured: 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

    Measured: Week 0, 6 and 12

  7. 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).

    Measured: Week 0, 6 and 12

  8. 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.

    Measured: Week 0, 6 and 12

  9. 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.

    Measured: Week 0, 6 and 12

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

    Measured: Week 1-6 and week 7-12

  11. Medication change

    Measured: Week 1-52

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

    Measured: Week 1-12

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

    Measured: Week 1-12

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

    Measured: Week 1-12

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

    Measured: Week 1-52

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted10 Sep 2015 (estimated)
  2. Study start17 Aug 2015
  3. Primary completion30 Apr 2017
  4. Study completion30 Apr 2017

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Crossover
Masking
None (open label)
Enrolment
30 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02545855
Sponsor's protocol ID
TRIRES1507
Other IDs
UMIN000017639
Status last verified
Apr 2018
First submitted
1 Sep 2015
Last updated
17 Apr 2018
Results posted
No
Data monitoring committee
No

Publications

  • 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.

    PubMed 29283682

Questions about this trial

What is this clinical trial studying?

A study testing High-flow nasal cannula therapy and Home oxygen therapy (HOT) in people with Chronic Obstructive Pulmonary Disease (COPD), run by Translational Research Center for Medical Innovation, Kobe, Hyogo, Japan at 1 site in Japan.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 17 Apr 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Japan. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02545855, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Apr 2018.

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