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The prevalence of uncontrolled status in patients with asthma under treatment with medium or high dose ICS/LABA with or without other controllers using

Uncontrolled asthma with medium or high-dose ICS/LABA

454

Of the 491 enrolled patients, 454 comprised the full analysis set (FAS) who fulfilled all the inclusion criteria From these patients, 52 were treated with ICS/LABA with LAMA or a fixed-dose combination of ICS/LABA/LAMA and comprised the ICS/LABA/LAMA subpopulation. Of the 454 patients, 451 (99.3%) completed the study Of all patients included in the study, >60% were female The age (mean +- SD) of the patients was 54.4 +- 12.2 years. Overall, the patients had a healthy body weight (64.0 +- 13.8), and the BMI (mean +- SD) was 24.6 +- 4.8 kg/m2 Most of the patients had never smoked (67.4%), while only a few were current smokers (5.7%) and former smokers (26.9%). Patients had their asthma symptoms for a mean duration of ~13.5 years, and the most common comorbidity was uncomplicated diabetes (5.9%)

Patients with written informed consent (V0); 491 - Screening failure; 13 Patients screened (V0); 478 - No enrollment; 24 [Withdrawal of informed consent (n = 16), Deviation from allowance at V1 (n = 2), Asthma worsening before V1 (n = 6)] Patients enrolled (V1); 454 (Full analysis set) - Discontinuation; 3 [Deviation from allowance at V2 (n = 3)] Patients with 12-follow up period completed (V2); 451 [ICS/LABA/LAMA subpopulation, n = 52]

Not applicable due to the nature of study concept and design (NIS) which did not focus on Novartis product

For the primary endpoint based on the JGL 2018 criteria, 244 (53.7%) of the patients reported their asthma as uncontrolled at Visit 1 and/or Visit 2. The proportions of patients with uncontrolled asthma at Visit 1 and/or Visit 2 were lower (165 [36.3%] patients) when evaluating the primary endpoint based on the GINA 2019 criteria compared with the JGL 2018 criteria.

The patients in each of the four sub-cohorts were broadly similar. In the J-cohorts, the mean (SD) ages were 54.4 (12.0) years for uncontrolled and 54.5 (12.5) years for controlled, while in the G-cohorts, they were 55.0 [11.9] years and 53.4 (12.7) years, respectively. Approximately >60% of patients in all the cohorts were females. The duration of asthma did not show any trend across the four cohorts. However, there were some differences in BMI. Slightly higher proportions of patients in the uncontrolled cohorts were treated in the clinic (as opposed to hospital) when compared to the respective controlled cohorts. Greater proportions of the patients in the uncontrolled cohorts were smokers than in the controlled cohorts.

Overall, 454 patients were included into the study from 18 sites across Japan. For the primary endpoint based on the JGL 2018 criteria, 244 (53.7%) of the patients reported their asthma as uncontrolled at Visit 1 and/or Visit 2. The proportions of patients with uncontrolled asthma at Visit 1 and/or Visit 2 were lower (165 [36.3%] patients) when evaluating the primary endpoint based on the GINA 2019 criteria compared with the JGL 2018 criteria.

No

Novartis Pharma K.K.

Novartis Pharma K.K.

+81-120-003-293

completed

Oct. 31, 2020

Observational

Non-interventional study which consists of an up to 1-year retrospective chart review and a 12-week follow-up period after patient enrollment

other

N/A

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

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.

Both

Asthma

investigational material(s)
Generic name etc : -
INN of investigational material : -
Therapeutic category code : 225 Bronchodilators
Dosage and Administration for Investigational material : -

control material(s)
Generic name etc : -
INN of investigational material : -
Therapeutic category code :
Dosage and Administration for Investigational material : -

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

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

+81-3-6779-8161

July. 15, 2020