UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000030419 |
|---|---|
| Receipt number | R000034735 |
| Scientific Title | Multi-center, observational study for evaluating the asthma control level between patients and physicians (MARGIN Survey) |
| Date of disclosure of the study information | 2017/12/15 |
| Last modified on | 2019/03/27 14:27:50 |
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Basic information
Public title
Multi-center, observational study for evaluating the asthma control level between patients and physicians (MARGIN Survey)
Acronym
Multi-center, observational study for evaluating the asthma control level between patients and physicians (MARGIN Survey)
Scientific Title
Multi-center, observational study for evaluating the asthma control level between patients and physicians (MARGIN Survey)
Scientific Title:Acronym
Multi-center, observational study for evaluating the asthma control level between patients and physicians (MARGIN Survey)
Region
| Japan |
Condition
Condition
Bronchial Asthma
Classification by specialty
| Pneumology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate whether or not there is a difference in the evaluation of asthma control levels between the asthma patients and the physicians.
Basic objectives2
Others
Basic objectives -Others
Comparison of the various asthma measurement scales
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
Evaluation of the GAP between JGL-JACS and JGL-ACQ at Week 0
Comparison of the agreement of asthma control levels based on JACS against JGL and ACQ against JGL
Key secondary outcomes
(1) Evaluation at Week 0 and Week 24
- Agreement of control levels between each control evaluation (JGL, GINA, ACQ, JACS)
- Agreement of treatment satisfaction (patient-physician evaluated)
- Correlation between control levels and treatment satisfaction
(2) The changes from Week 0 to Week 24
- Frequency of exacerbation (unscheduled clinic/hospital visits, use of systemic steroids)
- Period until exacerbation
- Change in each control evaluation
- Change in treatment satisfaction (physician and patient)
- Change in respiratory function
- Change in the GAP of control levels (physician-patient)
- Change in the GAP between control levels and treatment satisfaction (between patients, between physicians)
(3) Cluster analysis at Week 0
- Long-term control medication
- Each patient background characteristic
- Result of control levels and treatment satisfaction
- Respiratory function
- Type of medical facility
- Presence or absence of ACO
(4) Cluster analysis for exacerbation
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
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
| 20 | years-old | <= |
Age-upper limit
| 80 | years-old | > |
Gender
Male and Female
Key inclusion criteria
1) Patients diagnosed with asthma (including ACO) according to the Asthma Prevention and Management Guideline 2015
2) Patients who can provide written informed consent to participate in the study
3) Outpatients at least 20 and under 80 years of age
4) Patients continuing ICS/LABA treatment for at least 4 weeks
5) Patients who have been visiting the clinic/hospital for at least the previous 1 year
6) Patients with no communication problems
Key exclusion criteria
1) Patients with a concomitant malignant tumor
2) Patients with apparent COPD
3) Patients with a history of respiratory infection (including viral infection) within the past 4 weeks
4) Patients who are breastfeeding, pregnant, or hoping to become pregnant during the study period
5) Other patients who are judged unsuitable for participation by the Principal or Sub Investigators
Target sample size
400
Research contact person
Name of lead principal investigator
| 1st name | Yuji |
| Middle name | |
| Last name | Tohda |
Organization
Kinki Hokuriku Airway disease Conference (KiHAC)
Division name
Board Director
Zip code
589-8511
Address
377-2 Ohnohigashi, Osakasayama, Osaka, Japan
TEL
072-366-0221
koare-kyoju@med.kindai.ac.jp
Public contact
Name of contact person
| 1st name | Nobuhide |
| Middle name | |
| Last name | Mori |
Organization
Mebix, Inc.
Division name
Research Promotion Group
Zip code
107-0052
Address
Akasaka Intercity,1-11-44 Akasaka, Minato-ku,Tokyo
TEL
03-4362-4504
Homepage URL
margin@mebix.co.jp
Sponsor or person
Institute
Kinki Hokuriku Airway disease Conference (KiHAC)
Institute
Department
Personal name
Funding Source
Organization
KYORIN Pharmaceutical Co., Ltd.
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
Ethics Committee of Goshogatani Home Clinic
Address
Laforet Maizuru,1-6-1,Maizuru,Chuo-ku, Fukuoka-shi, Fukuoka,Japan
Tel
092-739-8525
gosho_irb@yahoo.co.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 | 12 | Month | 15 | 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
420
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 | 12 | Month | 14 | Day |
Date of IRB
| 2017 | Year | 12 | Month | 13 | Day |
Anticipated trial start date
| 2017 | Year | 12 | Month | 18 | Day |
Last follow-up date
| 2018 | Year | 11 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
- Study design: Multi-center, prospective, observational study
- Patient enrollment period: December 2017-May 2018
Management information
Registered date
| 2017 | Year | 12 | Month | 15 | Day |
Last modified on
| 2019 | Year | 03 | Month | 27 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000034735
