Study of Long-term HFNC for COPD Patients with HOT (FLOCOP)

November 17, 2024 updated by: Translational Research Center for Medical Innovation, Kobe, Hyogo, Japan

Efficacy and Safety of Long-term High-flow Nasal Cannula Oxygen Therapy in Stable COPD Patients with Home Oxygen Therapy (HOT): a Multicenter, Prospective, Randomized Controlled Study

This is a prospective, randomized parallel study for evaluation of the efficacy and safety of long-term nocturnal high-flow nasal cannula therapy (HFNC: with the myAIRVO2 as HFNC in this study) in stable COPD patients with the global initiative for chronic obstructive lung disease (GOLD) stage 2-4, PaCO2 >= 45 Torr and hypercapnia who require home oxygen therapy (HOT) using COPD exacerbation (Moderate or Severe).

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

An abroad study of the stable COPD patients was reported that HFNC usage decreased the frequency of COPD exacerbation.

In addition, the result of the pilot study (NCT02545855) of the stable COPD patient in Japan is indicated that HOT with HFNC improved their QOL and PaCO2 by comparing to HOT only.

Therefore, this study is planned to indicate the efficacy of HFNC which can increase the ventilation efficiency and have the function of heated humidification, by comparing HOT with HFNC to HOT only.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
120

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Japan
    • Hyogo
      • Kobe, Hyogo, Japan, 6500047
        • Kobe City Medical Center General Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

40 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  1. Patients who are diagnosed with the global initiative on obstructive lung disease (GOLD) stage 2-4 COPD.
  2. Patients who have received nocturnal HOT 16 hours or more per day for 1 month or more at the time of the informed consent.
  3. Patients with PaCO2 >= 45 Torr and pH >= 7.35 at screening.
  4. Patients with COPD exacerbation (Moderate or Severe; judged by the investigators) within the past 1 year prior to the informed consent.
  5. Patients who are more than 40 years old at the time of the informed consent.
  6. Patients who agree to participate in the study with the written informed consent.

Exclusion Criteria:

  1. Patients with severe kidney, liver or cardiovascular disease.
  2. Patients with active malignant tumor.
  3. Patients with acute disease.
  4. Patients who are diagnosed with asthma. (Excluding COPD patients with history of asthma).
  5. Patients who have any history of obstructive sleep apnea syndrome (OSAS) or are highly-suspected cases in the clinical. (Excluding patients who are denied the diagnosis of OSAS by the result of overnight polysomnography.)
  6. Patients with diseases that affecting the efficacy endpoints (for example: active pulmonary infection, clinically significant pulmonary fibrosis and bronchiectasis, α-1-antitrypsin deficiency etc.,) and are regarded as inadequate for the study by the investigators.
  7. Patients who have experienced a COPD exacerbation (any Severity: judged by the investigators) within the past 4 weeks prior to the informed consent.
  8. Patients who are receiving nocturnal noninvasive positive pressure ventilation (NPPV), or who had been received it within 4 weeks prior to the informed consent.
  9. Patients who have used HFNC at home within the past 1 year prior to the informed consent, or are using any HFNC. (Excluding patients who used HFNC during hospitalization due to acute respiratory failure within 1 year prior to the informed consent.)
  10. Patients with history of tracheotomy, severe pharyngeal surgery or severe nasal cavity surgery within the past 6 months prior to the informed consent.
  11. Patients who are pregnant.
  12. Patients with cognitive impairment or mental disorder who are regarded as inadequate to evaluate for the study by the investigators.
  13. Patients who are regarded as being unable to operate the myAIRVO2 adequately at home by the investigators.
  14. Patients who have participated in the other study at the time of the informed consent, or will participate in the other study.
  15. Any other cases who are regarded as inadequate for the study enrollment by the investigators.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Arm A(myAIRVO2® + HOT)
Subjects receive following protocol treatment; Home oxygen therapy (HOT) plus nocturnal high-flow nasal cannula therapy with the myAIRVO2 within 52weeks.
Device: High-flow nasal cannula therapy
Subjects will receive nocturnal high-flow nasal cannula therapy with the myAIRVO2®, in addition to their current Home oxygen therapy (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®
Device: Home oxygen therapy (HOT)
All subjects will continue their current Home oxygen therapy (HOT) which kept original usage conditions at the time of enrollment throughout the entire duration of the study regardless of treatment arm assignment.
Active Comparator: Arm B(HOT)
Subjects receive following protocol treatment; Home oxygen therapy (HOT) only within 52weeks.
Device: Home oxygen therapy (HOT)
All subjects will continue their current Home oxygen therapy (HOT) which kept original usage conditions at the time of enrollment throughout the entire duration of the study regardless of treatment arm assignment.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Frequency (the number of occurrences per year) of COPD exacerbation (Moderate or Severe)
Time Frame: 52weeks
COPD exacerbation will be assessed by the disease diary which is kept by each patient within the term of intervention.
52weeks

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Term from enrollment to the date of first COPD exacerbation (Moderate or Severe)
Time Frame: up to 52 weeks

The term from enrollment to the date of first COPD exacerbation is a duration from the start of intervention (Week0) to the date of first COPD exacerbation or death from any cause which ever comes first.

The date of first COPD exacerbation will be assessed by the disease diary which is kept by each patient within the term of intervention.
up to 52 weeks
Term from enrollment to death from any cause
Time Frame: up to 52 weeks
Term from enrollment to death from any cause is a duration from the start of intervention (Week0) to death from any cause.
up to 52 weeks
Frequency (the number of occurrences per year) of COPD exacerbation (All Severity and Severe only)
Time Frame: 52weeks
COPD exacerbation will be assessed by the disease diary which is kept by each patient within the term of intervention.
52weeks
Total St. George's respiratory questionnaire (SGRQ-C) score, and each components score (symptom score, activity score, and impact score)
Time Frame: at 0, 12, 24 and 52 weeks
SGRQ-C score will be assessed by Japanese version of the SGRQ-C value sets including each components score (symptom score, activity score, and impact score).
at 0, 12, 24 and 52 weeks
Quality-adjusted life year (QALY) by mapping the EQ-5D-5L utility scores
Time Frame: at 0, 12, 24 and 52 weeks
Quality-adjusted life year (QALY) of the subjects will be assessed by Japanese version of the EQ-5D-5L value sets including assessment of changes from baseline in the EQ-5D-5L utility index scores and visual analogue scale scores.
at 0, 12, 24 and 52 weeks
Total SRI (Severe Respiratory Insufficiency Questionnaire) score
Time Frame: at 0, 12, 24 and 52 weeks
Total SRI score will be assessed by Japanese version of the SRI value sets.
at 0, 12, 24 and 52 weeks
Total PSQI-J(Japanese version of the Pittsburgh Sleep Quality Index) score
Time Frame: at 0, 12, 24 and 52 weeks
Total PSQI-J score will be assessed by Japanese version of the PSQI value sets.
at 0, 12, 24 and 52 weeks
Dyspnea intensity: the modified medical research council (mMRC) score
Time Frame: 52weeks
Dyspnea intensity will be evaluated by the modified medical research council (mMRC) score.
52weeks
Arterial blood gas analysis (ABG): pH, PaO2, PaCO2, HCO3-, BE
Time Frame: 52weeks
ABG will be evaluated by the blood gas analysis equipment.
52weeks
Oxygen Saturation (SpO2)
Time Frame: 52weeks
SpO2 will be evaluated by Pulse Oximeter.
52weeks
Pulmonary functions: FVC, FEV1, FEV1%
Time Frame: 52weeks
Lung function of the 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.
52weeks
6-minute walk test (6MWT)
Time Frame: at 0, 12, 24 and 52 weeks
6MWT for the respiration rehabilitation is defined as the functional exercise capacity which is assessed by the following indicators: the distance (m), changes in pre- and post-6MWT pulse oximeter (SpO2), and post-6MWT modified borg scale.
at 0, 12, 24 and 52 weeks
Term from enrollment to the date of long-term (more than 1month) NPPV(Noninvasive Positive Pressure Ventilation) usage
Time Frame: 52weeks

The term from the start of intervention (Week0) to the date of Long-term NPPV usage.

Long-term NPPV usage is defined as more than 1month NPPV usage.
52weeks
Flow rate(Oxygen / Total) (Arm A only)
Time Frame: 52weeks
Oxygen flow rate / Total flow rate will be confirmed by the record of numerical value displayed on the device.
52weeks
Total hours of myAIRVO2-use (Arm A only)
Time Frame: 52weeks
Total hours of myAIRVO2-use will be confirmed by the record of numerical value displayed on the device.
52weeks
Adverse events
Time Frame: 52weeks
Adverse events will be determined by the latest version of MedDRA/J （Medical Dictionary for Regulatory Activities/J）at the time of Database lock.
52weeks

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Correlation between frequency of COPD exacerbation (All Severity and Severe only) and amount of ABG change
Time Frame: 52weeks
Amount of ABG change will be calculated by the ABG value at before and after the intervention.
52weeks
Correlation between frequency of COPD exacerbation (All Severity and Severe only) and amount of SpO2 change
Time Frame: 52weeks
Amount of SpO2 change will be calculated by the ABG value of before and after the intervention.
52weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Translational Research Center for Medical Innovation, Kobe, Hyogo, Japan

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Kobe City Medical Center General Hospital

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Keisuke Tomii, MD, Ph.D., Kobe City Medical Center General Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
September 6, 2017

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
October 28, 2020

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
October 28, 2020

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
September 7, 2017

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 11, 2017

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
September 13, 2017

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
November 20, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 17, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
January 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • TRIRES1668
  • UMIN000028581 (Registry Identifier: UMIN-CTR)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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