UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000034263 |
|---|---|
| Receipt number | R000039066 |
| Scientific Title | Investigation of the merger ratio of Obstructive Sleep Apnea(OSA) in Bronchial Asthma(BA) and search for biomarkers of OSA-associated BA |
| Date of disclosure of the study information | 2018/09/25 |
| Last modified on | 2021/03/28 15:22:25 |
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Basic information
Public title
Investigation of the merger ratio of Obstructive Sleep Apnea(OSA) in Bronchial Asthma(BA) and search for biomarkers of OSA-associated BA
Acronym
OSA merger rate in asthma
Scientific Title
Investigation of the merger ratio of Obstructive Sleep Apnea(OSA) in Bronchial Asthma(BA) and search for biomarkers of OSA-associated BA
Scientific Title:Acronym
OSA merger rate in asthma
Region
| Japan |
Condition
Condition
Bronchial Asthma/Obstructive Sleep Apnea
Classification by specialty
| Pneumology | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To clarify OSA merger rate in bronchial asthma and biomarkers for diagnosis and treatment of OSA-associated asthma
Basic objectives2
Others
Basic objectives -Others
Survey
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
OSA merger rate in asthma
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Diagnosis
Type of intervention
| Device,equipment |
Interventions/Control_1
out-of-center sleep testing
one day
Interventions/Control_2
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
| 18 | years-old | <= |
Age-upper limit
| 90 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Stable asthmatic patients
>=18 years old
Key exclusion criteria
COPD, Lung Cancer, Interstitial Pneumonia,poorly controlled heart failure, neuromuscular disease
Target sample size
80
Research contact person
Name of lead principal investigator
| 1st name | Kazunori |
| Middle name | |
| Last name | Tobino |
Organization
Iizuka Hospital
Division name
Respiratory medicine
Zip code
8208505
Address
3-83 Yoshiomachi,Iizuka Fukuoka
TEL
0948223800
mina0628mina@gmail.com
Public contact
Name of contact person
| 1st name | Mina |
| Middle name | |
| Last name | Yasuda |
Organization
Iizuka Hospital
Division name
Respiratory medicine
Zip code
8208505
Address
3-83 Yoshiomachi,Iizuka Fukuoka
TEL
0948223800
Homepage URL
mina0628mina@gmail.com
Sponsor or person
Institute
department of respiratory medicine Iizuka Hospital
Institute
Department
Personal name
Funding Source
Organization
Department of respiratory medicine Iizuka Hospital
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Department of Respiratory Medicine, Juntendo University Faculty of Medicine and Graduate School of Medicine
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Iizuka Hospital
Address
3-83 Yoshiomachi,Iizuka Fukuoka
Tel
0948223800
rinri@aih-net.com
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
| 2018 | Year | 09 | Month | 25 | 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
Open public recruiting
Date of protocol fixation
| 2017 | Year | 08 | Month | 22 | Day |
Date of IRB
| 2017 | Year | 08 | Month | 22 | Day |
Anticipated trial start date
| 2017 | Year | 08 | Month | 22 | Day |
Last follow-up date
| 2020 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
| 2021 | Year | 03 | Month | 31 | Day |
Date trial data considered complete
| 2021 | Year | 03 | Month | 31 | Day |
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2018 | Year | 09 | Month | 25 | Day |
Last modified on
| 2021 | Year | 03 | Month | 28 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000039066
