UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000028581 |
|---|---|
| Receipt number | R000032707 |
| 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 |
| Date of disclosure of the study information | 2017/08/08 |
| Last modified on | 2022/02/16 14:11:04 |
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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
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
kazuma_n1101@yahoo.co.jp
Sponsor or person
Institute
Kobe City Medical Center General Hospital
Department of Respiratory Medicine
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000032707
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