UMIN-CTR Clinical Trial

Basic information
Public 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
Acronym	Study of long-term HFNC for COPD patients with HOT (FLOCOP study)
Scientific 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
Scientific Title:Acronym	Study of long-term HFNC for COPD patients with HOT (FLOCOP study)
Region	Japan

Condition
Condition	Chronic Obstructive Pulmonary Disease (COPD)
Classification by specialty	Pneumology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	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).
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase	Not applicable

Assessment
Primary outcomes	Frequency (the number of occurrences per year) of COPD exacerbation (Moderate or Severe)
Key secondary outcomes	1. Term from enrollment to the date of first COPD exacerbation (Moderate or Severe) 2. Term from enrollment to death from any cause 3. Frequency (the number of occurrences per year) of COPD exacerbation (All Severity and Severe only) 4. Total St. George's respiratory questionnaire (SGRQ-C) score, and each components score (symptom score, activity score, and impact score) 5. Quality-adjusted life year (QALY) by mapping the EQ-5D-5L utility scores 6. Total SRI (Severe Respiratory Insufficiency Questionnaire) score 7. Total PSQI-J(Japanese version of the Pittsburgh Sleep Quality Index) score 8. Dyspnea intensity: the modified medical research council (mMRC) score 9. Arterial blood gas analysis (ABG): pH, PaO2, PaCO2, HCO3-, BE 10. Oxygen Saturation (SpO2) 11. Pulmonary functions: FVC, FEV1, FEV1% 12. 6-minute walk test (6MWT): 6-minute walk test distance, SpO2, modified borg scale (mBS) 13. Term from enrollment to the date of long-term (more than 1month) NPPV(Noninvasive Positive Pressure Ventilation) usage 14. Oxygen flow rate, and Total flow rate (Arm A only) 15. Total hours of myAIRVO2-use (Arm A only) 16. Adverse events

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Cluster
Blinding	Open -no one is blinded
Control	Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	2
Purpose of intervention	Treatment
Type of intervention	Device,equipment
Interventions/Control_1	Arm A (myAIRVO2+ HOT): Subjects receive following protocol treatment; HOT plus nocturnal high-flow nasal cannula therapy with the myAIRVO2 within 52weeks.
Interventions/Control_2	Arm B (HOT): Subjects receive following protocol treatment; HOT only within 52weeks.
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit	40 years-old <=
Age-upper limit	Not applicable
Gender	Male and Female
Key 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.
Key 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 the diagnosis with 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, a1-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.
Target sample size	120

Research contact person
Name of lead principal investigator	1st name Keisuke Middle name Last name Tomii
Organization	Kobe City Medical Center General Hospital
Division name	Department of Respiratory Medicine
Zip code	650-0047
Address	2-1-1 Minatojima-minamimachi, Chuo-ku, Kobe
TEL	078-302-4321
Email	ktomii@kcho.jp

Public contact
Name of contact person	1st name Kazuma Middle name Last name Nagata
Organization	Kobe City Medical Center General Hospital
Division name	Department of Respiratory Medicine
Zip code	650-0047
Address	2-1-1 Minatojima-minamimachi, Chuo-ku, Kobe
TEL	078-302-4321
Homepage URL
Email	kazuma_n1101@yahoo.co.jp

Sponsor
Institute	Kobe City Medical Center General Hospital Department of Respiratory Medicine
Institute
Department

Funding Source
Organization	Teijin Pharma Limited (Tokyo, Japan)
Organization
Division
Category of Funding Organization	Profit organization
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization	Kobe University Clinical Research Ethical Committee
Address	7-5-2 Kusunoki-cho, Chuo-ku, Kobe
Tel	078-382-6669
Email	cerb@med.kobe-u.ac.jp

Secondary IDs
Secondary IDs	NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions

Other administrative information
Date of disclosure of the study information	2017 Year 08 Month 08 Day

Related information
URL releasing protocol
Publication of results	Unpublished

Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status	Completed
Date of protocol fixation	2017 Year 06 Month 13 Day
Date of IRB	2019 Year 02 Month 14 Day
Anticipated trial start date	2017 Year 08 Month 15 Day
Last follow-up date	2020 Year 10 Month 26 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2017 Year 08 Month 08 Day
Last modified on	2022 Year 02 Month 16 Day

Link to view the page
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000032707