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

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: Completed
• Conditions: Chronic Obstructive Pulmonary Disease (COPD)
• Intervention / Treatment: Device: High-flow nasal cannula therapy; Device: Home oxygen therapy (HOT)

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: Interventional
• Enrollment (Actual): 120
• Phase: Not Applicable

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• 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

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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

Outcome Measure	Measure Description	Time Frame
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.	52weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	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.	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).	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.	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.	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.	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.	52weeks
Arterial blood gas analysis (ABG): pH, PaO2, PaCO2, HCO3-, BE	ABG will be evaluated by the blood gas analysis equipment.	52weeks
Oxygen Saturation (SpO2)	SpO2 will be evaluated by Pulse Oximeter.	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.	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.	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.	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.	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.	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.	52weeks

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Correlation between frequency of COPD exacerbation (All Severity and Severe only) and amount of ABG change	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	Amount of SpO2 change will be calculated by the ABG value of before and after the intervention.	52weeks

Collaborators and Investigators

• Sponsor: Translational Research Center for Medical Innovation, Kobe, Hyogo, Japan
• Collaborators: Kobe City Medical Center General Hospital
• Investigators: Principal Investigator: Keisuke Tomii, MD, Ph.D., Kobe City Medical Center General Hospital

Study record dates

Study Major Dates

• Study Start (Actual): September 6, 2017
• Primary Completion (Actual): October 28, 2020
• Study Completion (Actual): October 28, 2020

Study Registration Dates

• First Submitted: September 7, 2017
• First Submitted That Met QC Criteria: September 11, 2017
• First Posted (Actual): September 13, 2017

Study Record Updates

• Last Update Posted (Actual): November 20, 2024
• Last Update Submitted That Met QC Criteria: November 17, 2024
• Last Verified: January 1, 2021

More Information

Terms related to this study

• Keywords: COPD; myAIRVO2; high-flow nasal cannula therapy; home oxygen therapy; HOT
• Additional Relevant MeSH Terms: Pathologic Processes; Chronic Disease; Disease Attributes; Respiratory Tract Diseases; Lung Diseases; Lung Diseases, Obstructive; Pulmonary Disease, Chronic Obstructive
• Other Study ID 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