Asthma
Conditions
Interventions
investigational material(s)
Generic name etc : -
INN of investigational material : -
Therapeutic category code : 225 Bronchodilators
Dosage and Administration for Investigational material : -
control
Sponsors
Novartis Pharma K.K.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Written informed consent must be obtained before study entry. 2) Male and female adult patients 20 to 75 years of age at the time of enrollment. 3) Patients with a documented physician diagnosis of asthma for >=1 year prior to the enrollment. 4) Patients who have been prescribed with medium or high dose ICS/LABA for >=3 months and a stable dose of ICS/LABA for >=1 month with or without other controllers (e.g., leukotriene receptor antagonist [LTRA], LAMA, theophylline, OCS) prior to the enrollment 5) Past medical history is available
Exclusion criteria
Exclusion criteria: 1) Patients who have used any biologics (e.g., omalizumab, mepolizumab, benralizumab, dupilumab) within 4 months before the study entry. 2) Patients who are treated with single inhaler maintenance and reliever therapy (SMART); use of budesonide (BUD)/formoterol fumarate (FM) as a controller is allowed. 3) Patients with chronic lung diseases other than asthma including (but not limited to) chronic obstructive pulmonary disease (COPD), sarcoidosis, interstitial lung disease, cystic fibrosis, clinically significant bronchiectasis and active tuberculosis. 4) Patients who had a severe exacerbation within 1 month before enrollment; severe exacerbation is aggravation of asthma symptoms requiring systemic corticosteroids for at least three consecutive days and/or need for an ER visit or hospitalization due to asthma, based on the definition by European Respiratory Society (ERS)/American Thoracic Society (ATS) guidelines.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| other The percentage of patients with uncontrolled asthma among all asthma patients treated with medium or high dose ICS/LABA with or without other controller(s) during the 12-week follow-up period, based on JGL 2018 and GINA 2019 | — |
Secondary
| Measure | Time frame |
|---|---|
| other 1) Demographics and clinical characteristics of patients (at the timing of enrollment) with controlled and uncontrolled asthma other 2) Treatment patterns for asthma of patients (at the timing of enrollment) with controlled and uncontrolled asthma other 3) Prorated annual HCRU-related variables of patients with controlled and uncontrolled asthma (pre-index period) other 4) Patient-reported outcomes using the following questionnaires of patients (at the timing of enrollment and at Week 12) with controlled and uncontrolled asthma other 5) Adherence to asthma-related prescriptions for the past 4 weeks of patients with controlled and uncontrolled asthma at the timing of enrollment and at Week 12 | — |
Countries
Japan
Outcome results
None listed