Multi-center, observational study for evaluating the asthma control level between patients and physicians (MARGIN Survey)

Multi-center, observational study for evaluating the asthma control level between patients and physicians (MARGIN Survey) - Multi-center, observational study for evaluating the asthma control level between patients and physicians (MARGIN Survey)

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

JPRN

Registry ID

JPRN-UMIN000030419

Enrollment

400

Registered

2017-12-15

Start date

2017-12-18

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Bronchial Asthma

Interventions

None listed

Eligibility

Sex/Gender

All

Inclusion criteria

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

Exclusion criteria

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

Design outcomes

Primary

Measure	Time frame
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	—

Secondary

Measure	Time frame
(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	—

Measure

Time frame

(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

—

Countries

Japan

Contacts

Public ContactNobuhide Mori

Mebix, Inc. Research Promotion Group

margin@mebix.co.jp03-4362-4504

Outcome results