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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000017639
Receipt No. R000020440
Scientific Title Long-term high-flow nasal cannula therapy in patients with stable COPD: a prospective, randomized crossover study
Date of disclosure of the study information 2015/05/21
Last modified on 2017/11/21

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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
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization
Address
Tel
Email

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
Registered date File name


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