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

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 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

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

Value
https://center6.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