UMIN-CTR Clinical Trial

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
Last 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
1st 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