Bronchial asthma
Conditions
Interventions
None listed
Sponsors
Kindai University
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Patients who meet all of the following criteria at the visit1: (1) Asthma patients (patients diagnosed with mild to severe persistent type according to JGL 2015, accounting for current treatment in the severity classification) (2) Patients who can provide written consent (3) Patients between 20 and 80 years old (4) Patients who have been using ICS/LABA for at least 4 weeks (5) Patients with partly controlled(fulfill at least 2 criteria for inadequate control) or uncontrolled asthma according to JGL 2015 (6) Patients planned for medication use guidance (7) Patients with the ability to adequately understand the method of inhaler use, as well as adequately maintained motor function of the fingers for the purpose of inhaler use (8) Patients without communication problems
Exclusion criteria
Exclusion criteria: Patients who meet any of the following criteria at the visit1 are not selected as subjects: (1) Patients with a clear concomitant diagnosis of COPD (2) Patients with a concomitant diagnosis of malignant tumor (3) Patients with a history of smoking within the past 1 year (4) Patients with a history of respiratory infection (including viral infection) within the past 4 weeks (5) Patients who have experienced side effects from the use of ICS, LABA or the combined medications (6) Patients with a contraindication to the use of ICS and/or LABA (7) Patients who are using long-term oral steroids or are using anti-IgE antibodies (8) Patients who have deformation or palsy of the fingers, such that it is determined that they cannot correctly use the inhaler (9) Patients with dementia, etc., for which it has been determined that they cannot adequately understand the method of inhaler use (10) Patients who are pregnant, breastfeeding, or hoping to become pregnant during the study period (11) Other patients who are judged by the researchers to be unsuitable as a subject
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The change in JACS score (total score) between week 0 (Visit 1) and week 4 (Visit 2) | — |
Secondary
| Measure | Time frame |
|---|---|
| (1) Control level (2) QOL assessment (MiniAQLQ) (3) Respiratory function tests (4) JACS questionnaire accuracy (5) Confirmation of inhalation technique (6) ICS/LABA drug-specific evaluation (including device-specific evaluation) of the above items (7) Analysis of the above items according to patient demographic factors (8) JACS cut-off value calculation (9) Correlation(s) between JACS, ACQ and MiniAQLQ (10) Correlation(s) of items within the JACS questionnaire (11) Consideration of the clinical significance of the JACS questionnaire | — |
Countries
Japan
Contacts
Public ContactNaoyoshi Sugiyama
Mebix, Inc. Research promotion division
Outcome results
None listed