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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000030419
Receipt No. 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

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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
Email 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
Email margin@mebix.co.jp

Sponsor
Institute Kinki Hokuriku Airway disease Conference (KiHAC)
Institute
Department

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
Email 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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000034735

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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