UMIN-CTR Clinical Trial

Basic information
Public title	Long-term high-flow nasal cannula therapy in patients with stable COPD: a prospective, randomized crossover study
Acronym	High-flow nasal cannula therapy for stable COPD
Scientific Title	Long-term high-flow nasal cannula therapy in patients with stable COPD: a prospective, randomized crossover study
Scientific Title:Acronym	High-flow nasal cannula therapy for stable COPD
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 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 the global initiative for chronic obstructive lung disease (GOLD) stage 2-4, PaCO2 >=45 torr and hypercapnia who require home oxygen therapy (HOT) using health related quality of life (HRQOL).
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase	Not applicable

Assessment
Primary outcomes	1. Total St. George's respiratory questionnaire (SGRQ-C) score.
Key secondary outcomes	1. Quality-adjusted life year (QALY) by mapping the EQ-5D-5L utility scores 2. SGRQ-C: symptom score, activity score, impact score 3. Dyspnea intensity: the modified medical research council (mMRC) score 4. Arterial blood gas analysis (ABG): pH, PaO2, PaCO2 5. Oxygen Saturation (SpO2) 6. Nocturnal PtcCO2: median and 95th percentile 7. Pulmonary functions: VC, FVC, FEV1, FEV1/FVC, DLCO, RV, FRC, TLC 8. 6 minutes walk test (6MWT): 6- minute walk test distance, SpO2, modified borg scale (mBS) 9. Physical activity: calorie consumption, step-counts, activity time 10. Hospitalization for exacerbation 11. Medication change 12. Oxygen flow rate 13. Total flow rate 14. Adverse events

Base
Study type	Interventional

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

Intervention
No. of arms	3
Purpose of intervention	Treatment
Type of intervention	Device,equipment
Interventions/Control_1	Arm A (1-12 weeks): The treatment cycle is 6 weeks and is continued for up to 2 cycles (12 weeks). Subjects receive HOT plus nocturnal high-flow nasal cannula therapy with the myAIRVO2 for the 1st cycle, and HOT only for the 2nd cycle. The myAIRVO2 is used for 4 hours or more per day with flow rates of 40 L/min. HOT is used in the same way as the subject's current treatment at starting the study.
Interventions/Control_2	Arm B (1-12 weeks): The treatment cycle is 6 weeks and is continued for up to 2 cycles (12 weeks). Subjects receive HOT only with the myAIRVO2 for the 1st cycle, and HOT plus nocturnal high-flow nasal cannula therapy for the 2nd cycle. The myAIRVO2 is used for 4 hours or more per day with flow rates of 40 L/min. HOT is used in the same way as the subject's current treatment at starting the study.
Interventions/Control_3	Continuation period (13-52 weeks): If subjects wish, HOT plus the myAIRVO2 is continued for total up to 52 weeks after the 2nd cycle.
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	20 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 <= 60 torr and >= 45 torr at screening. 4. 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 with any history of obstructive sleep apnea syndrome. 5. Patients with diseases affecting the efficacy endpoints who are regarded as inadequate for the study by the investigators. 6. Patients who have experienced a COPD exacerbation within the past 6 weeks prior to the informed consent. 7. Patients who have received nocturnal noninvasive positive pressure ventilation (NPPV), or had received it within 6 weeks prior to the informed consent. 8. Patients with history of tracheotomy, severe pharyngeal surgery or severe nasal cavity surgery within the last 6 months. 9. Patients who are pregnant. 10. Patients with cognitive impairment or mental disorder who are regarded as inadequate to evaluate for the study by the investigators. 11. Patients who are regarded as being unable to operate the myAIRVO2 inadequately at home by the investigators. 12. Patients who have participated in the other study at the time of the informed consent, or will participate in the other study. 13. Any other cases who are regarded as inadequate for the study enrollment by the investigators.
Target sample size	30

Research contact person
Name of lead principal investigator	1st name Middle name Last name Keisuke Tomii
Organization	Kobe City Medical Center General Hospital
Division name	Department of Respiratory Medicine
Zip code
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 Middle name Last name Kazuma Nagata
Organization	Kobe City Medical Center General Hospital
Division name	Department of Respiratory Medicine
Zip code
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	Japan

Other related organizations
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IRB Contact (For public release)
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Tel
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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	聖路加国際病院（東京都） 松江医療センター（島根県） 財団法人田附興風会医学研究所北野病院（大阪府） 前橋赤十字病院（群馬県） 大垣市民病院（岐阜県） 倉敷中央病院（岡山県） 京都大学（京都府）

Other administrative information
Date of disclosure of the study information	2015 Year 05 Month 21 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	2015 Year 05 Month 11 Day
Date of IRB
Anticipated trial start date	2015 Year 07 Month 01 Day
Last follow-up date	2017 Year 04 Month 01 Day
Date of closure to data entry	2017 Year 07 Month 01 Day
Date trial data considered complete	2017 Year 08 Month 01 Day
Date analysis concluded	2017 Year 10 Month 30 Day

Other
Other related information

Management information
Registered date	2015 Year 05 Month 21 Day
Last modified on	2017 Year 11 Month 21 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000020440

Research Plan
Registered date	File name

Research case data specifications
Registered date	File name

Research case data
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