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UMIN-CTR Clinical Trial |
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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 |
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 |
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Condition | ||
Condition | Chronic Obstructive Pulmonary Disease (COPD) | |
Classification by specialty |
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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 |
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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. |
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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. |
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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. |
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Interventions/Control_4 | ||
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Interventions/Control_9 | ||
Interventions/Control_10 |
Eligibility | ||||
Age-lower limit |
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Age-upper limit |
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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. |
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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. |
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Target sample size | 30 |
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Name of lead principal investigator |
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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 | ||||||
ktomii@kcho.jp |
Public contact | |||||||
Name of contact person |
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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 | |||||||
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 | |
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Category of Funding Organization | Profit organization |
Nationality of Funding Organization | Japan |
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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) |
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Date of disclosure of the study information |
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Publication of results | Unpublished |
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Recruitment status | Completed | ||||||
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Last modified on |
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Link to view the page | |
URL(English) | https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000020440 |
Research Plan | |
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Research case data specifications | |
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Research case data | |
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