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UMIN-CTR Clinical Trial |
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Name: | UMIN ID: |
Recruitment status | No longer recruiting |
Unique ID issued by UMIN | UMIN000027776 |
Receipt No. | R000030497 |
Scientific Title | Identification of phenotypes and endotypes by cluster analysis among patients with severe asthma in Japan |
Date of disclosure of the study information | 2017/07/03 |
Last modified on | 2019/12/18 |
Basic information | ||
Public title | Identification of phenotypes and endotypes by cluster analysis among patients with severe asthma in Japan | |
Acronym | NHOM-Asthma | |
Scientific Title | Identification of phenotypes and endotypes by cluster analysis among patients with severe asthma in Japan | |
Scientific Title:Acronym | NHOM-Asthma | |
Region |
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Condition | |||
Condition | Asthma | ||
Classification by specialty |
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Classification by malignancy | Others | ||
Genomic information | NO |
Objectives | |
Narrative objectives1 | To identify phenotypes and endotypes among severe asthmatics in Japan. Also to conduct a field survey to reveal medical practice for asthma. |
Basic objectives2 | Efficacy |
Basic objectives -Others | |
Trial characteristics_1 | Exploratory |
Trial characteristics_2 | |
Developmental phase | Not applicable |
Assessment | |
Primary outcomes | Phenotype classification in severe asthmatics |
Key secondary outcomes | Actual clinical practice for asthma and its' control status
Distribution of cluster-specific endotypes' distribution among patients with severe asthma |
Base | |
Study type | Observational |
Study design | |
Basic design | |
Randomization | |
Randomization unit | |
Blinding | |
Control | |
Stratification | |
Dynamic allocation | |
Institution consideration | |
Blocking | |
Concealment |
Intervention | |
No. of arms | |
Purpose of intervention | |
Type of intervention | |
Interventions/Control_1 | |
Interventions/Control_2 | |
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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) Asthma patients visiting study institutions.
2) Patients who developed asthma more than one year ago. 3) Age: patients aged 16 years or older at time of acquisition of informed consent. 4) Patients who provided written consents for this study by themselves. 5) With regard to "severe asthma patients", patients in the treatment step 3 or 4 in "Asthma Prevention and Management Guidelines 2015". (i.e., Treatment step 3: treatment with medium to high doses of inhaled corticosteroids plus any one or more from long-acting B2 stimulant, leukotriene receptor antagonist, theophylline and long-acting anticholinergic agent. Treatment step 4: treatment with high-dose inhaled corticosteroids plus two or more from long-acting B2 stimulant, leukotriene receptor antagonist, theophylline, long-acting muscarinic antagonist, anti-IgE antibodies and oral steroid.) |
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Key exclusion criteria | 1) Patients for whom the principal investigator or sub-investigators decided not suitable for participation in this study. | |||
Target sample size | 2500 |
Research contact person | |||||||
Name of lead principal investigator |
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Organization | National Hospital Organization Tokyo National Hospital | ||||||
Division name | The president of the hospital | ||||||
Zip code | 204-8585 | ||||||
Address | 3-1-1 Takeoka, Kiyose-shi, Tokyo,204-8585, JAPAN | ||||||
TEL | 042-491-2111 | ||||||
kenohta@tokyo-hosp.jp |
Public contact | |||||||
Name of contact person |
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Organization | National Hospital Organization Tokyo National Hospital | ||||||
Division name | Clinical Research Center, Center for Pulmonary Diseases | ||||||
Zip code | 204-8585 | ||||||
Address | 3-1-1 Takeoka, Kiyose-shi, Tokyo, 204-8585, JAPAN | ||||||
TEL | 042-491-2111 | ||||||
Homepage URL | |||||||
suzukawam@tokyo-hosp.jp |
Sponsor | |
Institute | National Hospital Organization Tokyo National Hospital |
Institute | |
Department |
Funding Source | |
Organization | National Hospital Organization |
Organization | |
Division | |
Category of Funding Organization | Other |
Nationality of Funding Organization | Japan |
Other related organizations | |
Co-sponsor | |
Name of secondary funder(s) |
IRB Contact (For public release) | |
Organization | National Hospital Organization Tokyo National Hospital |
Address | 3-1-1, Takeoka, Kiyose, Tokyo 240-8585, Japan |
Tel | 042-491-2111 |
goto.yumiko.zj@mail.hosp.go.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 |
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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 | No longer recruiting | ||||||
Date of protocol fixation |
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Date of IRB |
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Anticipated trial start date |
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Last follow-up date |
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Date of closure to data entry | |||||||
Date trial data considered complete | |||||||
Date analysis concluded |
Other | |
Other related information | Serological and urinary tests at time of registration, and a survey of control status for one year after registration are performed only in severe asthmatics. |
Management information | |||||||
Registered date |
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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=R000030497 |
Research Plan | |
Registered date | File name |
Research case data specifications | |
Registered date | File name |
Research case data | |
Registered date | File name |