Chronic Obstructive Pulmonary Disease (COPD)FLOCOPNCT03282019
Study of Long-term HFNC for COPD Patients with HOT
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.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 40 years and older
- Conditions the study is for
- Chronic Obstructive Pulmonary Disease (COPD)
- 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
- 120 participants
- Where
- 1 siteJapan
- Study dates
- 6 Sep 2017to 28 Oct 2020
- 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 40 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients who are diagnosed with the global initiative on obstructive lung disease (GOLD) stage 2-4 COPD.
- Patients who have received nocturnal HOT 16 hours or more per day for 1 month or more at the time of the informed consent.
- Patients with PaCO2 >= 45 Torr and pH >= 7.35 at screening.
- Patients with COPD exacerbation (Moderate or Severe; judged by the investigators) within the past 1 year prior to the informed consent.
- Patients who are more than 40 years old at the time of the informed consent.
- Patients who agree to participate in the study with the written informed consent.
Who cannot join
- Patients with severe kidney, liver or cardiovascular disease.
- Patients with active malignant tumor.
- Patients with acute disease.
- Patients who are diagnosed with asthma. (Excluding COPD patients with history of asthma).
- 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.)
- 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.
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- Patients who have experienced a COPD exacerbation (any Severity: judged by the investigators) within the past 4 weeks prior to the informed consent.
- Patients who are receiving nocturnal noninvasive positive pressure ventilation (NPPV), or who had been received it within 4 weeks prior to the informed consent.
- 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.)
- Patients with history of tracheotomy, severe pharyngeal surgery or severe nasal cavity surgery within the past 6 months prior to the informed consent.
- Patients who are pregnant.
- Patients with cognitive impairment or mental disorder who are regarded as inadequate to evaluate for the study by the investigators.
- Patients who are regarded as being unable to operate the myAIRVO2 adequately at home by the investigators.
- Patients who have participated in the other study at the time of the informed consent, or will participate in the other study.
- Any other cases who are regarded as inadequate for the study enrollment by the investigators.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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).
Read the 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.
- Being tested
- High-flow nasal cannula therapy, Home oxygen therapy (HOT)
- Keywords
- myAIRVO2, high-flow nasal cannula therapy, home oxygen therapy, HOT, COPD
- 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®
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.
Home oxygen therapy (HOT)Device
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.
| Study group | Role | What they receive |
|---|---|---|
| Arm A(myAIRVO2® + HOT) | Experimental | Subjects receive following protocol treatment; Home oxygen therapy (HOT) plus nocturnal high-flow nasal cannula therapy with the myAIRVO2 within 52weeks. Receives: Device: High-flow nasal cannula therapy; Device: Home oxygen therapy (HOT) |
| Arm B(HOT) | Active comparator | Subjects receive following protocol treatment; Home oxygen therapy (HOT) only within 52weeks. Receives: Device: Home oxygen therapy (HOT) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Frequency (the number of occurrences per year) of COPD exacerbation (Moderate or Severe)
COPD exacerbation will be assessed by the disease diary which is kept by each patient within the term of intervention.
Measured: 52weeks
Secondary outcomes (16)
Term from enrollment to the date of first COPD exacerbation (Moderate or Severe)
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.
Measured: up to 52 weeks
Term from enrollment to death from any cause
Term from enrollment to death from any cause is a duration from the start of intervention (Week0) to death from any cause.
Measured: up to 52 weeks
Frequency (the number of occurrences per year) of COPD exacerbation (All Severity and Severe only)
COPD exacerbation will be assessed by the disease diary which is kept by each patient within the term of intervention.
Measured: 52weeks
Total St. George's respiratory questionnaire (SGRQ-C) score, and each components score (symptom score, activity score, and impact score)
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).
Measured: at 0, 12, 24 and 52 weeks
Quality-adjusted life year (QALY) by mapping the EQ-5D-5L utility scores
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.
Measured: at 0, 12, 24 and 52 weeks
Total SRI (Severe Respiratory Insufficiency Questionnaire) score
Total SRI score will be assessed by Japanese version of the SRI value sets.
Measured: at 0, 12, 24 and 52 weeks
Total PSQI-J(Japanese version of the Pittsburgh Sleep Quality Index) score
Total PSQI-J score will be assessed by Japanese version of the PSQI value sets.
Measured: at 0, 12, 24 and 52 weeks
Dyspnea intensity: the modified medical research council (mMRC) score
Dyspnea intensity will be evaluated by the modified medical research council (mMRC) score.
Measured: 52weeks
Arterial blood gas analysis (ABG): pH, PaO2, PaCO2, HCO3-, BE
ABG will be evaluated by the blood gas analysis equipment.
Measured: 52weeks
Oxygen Saturation (SpO2)
SpO2 will be evaluated by Pulse Oximeter.
Measured: 52weeks
Pulmonary functions: FVC, FEV1, FEV1%
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.
Measured: 52weeks
6-minute walk test (6MWT)
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.
Measured: 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
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.
Measured: 52weeks
Flow rate(Oxygen / Total) (Arm A only)
Oxygen flow rate / Total flow rate will be confirmed by the record of numerical value displayed on the device.
Measured: 52weeks
Total hours of myAIRVO2-use (Arm A only)
Total hours of myAIRVO2-use will be confirmed by the record of numerical value displayed on the device.
Measured: 52weeks
Adverse events
Adverse events will be determined by the latest version of MedDRA/J （Medical Dictionary for Regulatory Activities/J）at the time of Database lock.
Measured: 52weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Sep 2017
- Study start6 Sep 2017
- Primary completion28 Oct 2020
- Study completion28 Oct 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Chronic Obstructive Pulmonary Disease (COPD)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- Translational Research Center for Medical Innovation, Kobe, Hyogo, Japan
- Sponsor type
- University, hospital or other
- Collaborators
- Kobe City Medical Center General Hospital
- Responsible party
- Sponsor
- Investigators
- Keisuke Tomii, MD, Ph.D., Principal investigator, Kobe City Medical Center General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03282019
- Sponsor's protocol ID
- TRIRES1668
- Other IDs
- UMIN000028581
- Acronym
- FLOCOP
- Status last verified
- Jan 2021
- First submitted
- 7 Sep 2017
- Last updated
- 20 Nov 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Nagata K, Horie T, Chohnabayashi N, Jinta T, Tsugitomi R, Shiraki A, Tokioka F, Kadowaki T, Watanabe A, Fukui M, Kitajima T, Sato S, Tsuda T, Kishimoto N, Kita H, Mori Y, Nakayama M, Takahashi K, Tsuboi T, Yoshida M, Hataji O, Fuke S, Kagajo M, Nishine H, Kobayashi H, Nakamura H, Okuda M, Tachibana S, Takata S, Osoreda H, Minami K, Nishimura T, Ishida T, Terada J, Takeuchi N, Kohashi Y, Inoue H, Nakagawa Y, Kikuchi T, Tomii K. Home High-Flow Nasal Cannula Oxygen Therapy for Stable Hypercapnic COPD: A Randomized Clinical Trial. Am J Respir Crit Care Med. 2022 Dec 1;206(11):1326-1335. doi: 10.1164/rccm.202201-0199OC.
PubMed 35771533
Study at a glance
From the registry record, last updated by the sponsor on 20 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT03282019
- Acronym / sponsor ID
- FLOCOP / TRIRES1668
- Keywords
- myAIRVO2, high-flow nasal cannula therapy, home oxygen therapy, HOT, COPD
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- Translational Research Center for Medical Innovation, Kobe, Hyogo, JapanUniversity, hospital or other
- Collaborators
- Kobe City Medical Center General Hospital
- Study start
- 6 Sep 2017 (actual)
- Primary completion
- 28 Oct 2020 (actual)
- Study completion
- 28 Oct 2020 (actual)
- First posted
- 13 Sep 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm A(myAIRVO2® + HOT) | Experimental | Device: High-flow nasal cannula therapy, Device: Home oxygen therapy (HOT)Subjects receive following protocol treatment; Home oxygen therapy (HOT) plus nocturnal high-flow nasal cannula therapy with the myAIRVO2 within 52weeks. |
| Arm B(HOT) | Active comparator | Device: Home oxygen therapy (HOT)Subjects receive following protocol treatment; Home oxygen therapy (HOT) only within 52weeks. |
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Patients who are diagnosed with the global initiative on obstructive lung disease (GOLD) stage 2-4 COPD.
- Patients who have received nocturnal HOT 16 hours or more per day for 1 month or more at the time of the informed consent.
- Patients with PaCO2 >= 45 Torr and pH >= 7.35 at screening.
- Patients with COPD exacerbation (Moderate or Severe; judged by the investigators) within the past 1 year prior to the informed consent.
- Patients who are more than 40 years old at the time of the informed consent.
Key exclusion criteria (15 listed)
- Patients with severe kidney, liver or cardiovascular disease.
- Patients with active malignant tumor.
- Patients with acute disease.
- Patients who are diagnosed with asthma. (Excluding COPD patients with history of asthma).
- 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.)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| High-flow nasal cannula therapyAlso: myAIRVO2®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. | Device | Arm A(myAIRVO2® + HOT) |
| 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. | Device | Arm A(myAIRVO2® + HOT), Arm B(HOT) |
Primary outcome
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.
16 secondary outcomes
Term from enrollment to the date of first COPD exacerbation (Moderate or Severe)
Time frame: up to 52 weeks
Term from enrollment to death from any cause
Time frame: up to 52 weeks
Frequency (the number of occurrences per year) of COPD exacerbation (All Severity and Severe only)
Time frame: 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
Quality-adjusted life year (QALY) by mapping the EQ-5D-5L utility scores
Time frame: at 0, 12, 24 and 52 weeks
Total SRI (Severe Respiratory Insufficiency Questionnaire) score
Time frame: 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
Dyspnea intensity: the modified medical research council (mMRC) score
Time frame: 52weeks
Arterial blood gas analysis (ABG): pH, PaO2, PaCO2, HCO3-, BE
Time frame: 52weeks
Oxygen Saturation (SpO2)
Time frame: 52weeks
Pulmonary functions: FVC, FEV1, FEV1%
Time frame: 52weeks
6-minute walk test (6MWT)
Time frame: 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
Flow rate(Oxygen / Total) (Arm A only)
Time frame: 52weeks
Total hours of myAIRVO2-use (Arm A only)
Time frame: 52weeks
Adverse events
Time frame: 52weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Nov 2024.
- Derived from this study: PubMed 35771533Nagata K, Horie T, Chohnabayashi N, Jinta T, Tsugitomi R, Shiraki A, Tokioka F, Kadowaki T, Watanabe A, Fukui M, Kitajima T, Sato S, Tsuda T, Kishimoto N, Kita H, Mori Y, Nakayama M, Takahashi K, Tsuboi T, Yoshida M, Hataji O, Fuke S, Kagajo M, Nishine H, Kobayashi H, Nakamura H, Okuda M, Tachibana S, Takata S, Osoreda H, Minami K, Nishimura T, Ishida T, Terada J, Takeuchi N, Kohashi Y, Inoue H, Nakagawa Y, Kikuchi T, Tomii K. Home High-Flow Nasal Cannula Oxygen Therapy for Stable Hypercapnic COPD: A Randomized Clinical Trial. Am J Respir Crit Care Med. 2022 Dec 1;206(11):1326-1335. doi: 10.1164/rccm.202201-0199OC.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Keisuke Tomii, MD, Ph.D. principal investigator
Kobe City Medical Center General Hospital
1 site in 1 country: see every site and its status.
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 6 inclusion and 15 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 20 Nov 2024. 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?
Frequency (the number of occurrences per year) of COPD exacerbation (Moderate or Severe) (time frame: 52weeks). 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 NCT03282019, 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 20 Nov 2024.