Post-marketing Surveillance (PMS) Study to Observe the Safety and Effectiveness of ARNUITY in Asthma Subjects in a Real World Setting

Incidence rate of adverse events (AEs) after ARNUITY administration

An AE is defined as any undesirable, unintended signs (e.g., abnormal laboratory findings), symptoms, or disease that may occur after administration or during use of the product, and does not necessarily have to have a causal relationship with the product.

Time frame: Up to 22months

Incidence rates of unexpected AEs and adverse drug reactions (ADRs)

An ADR is defined as an adverse event whose causal relationship with the product cannot be ruled out.

Time frame: Up to 22 months

Incidence rates of serious AEs (SAEs) and serious ADRs (SADRs)

A SAE refers to any one of the following adverse events, which: results in death or is life-threatening; results in or prolongs hospitalization; results in persistent or serious disability or incapacity; results in a birth defect or anomaly; or is an important medical event. SADR is defined a SAE whose causal relationship with the product cannot be ruled out.

Time frame: Up to 22 months

Number of subjects with abnormal findings as assessed by physician's effectiveness assessment

For the subjective assessment of effectiveness, the physicians shall assess physician's effectiveness assessment at Week 24 after administration of Arnuity, based on the pulmonary function test and/or asthma symptom control.

Time frame: Week 24

Change in Forced Expiratory Volume in 1 Second (FEV1) before and after ARNUITY administration

The physicians shall collect FEV1 data at Week 0 and Week 24 after Arnuity administration. The change in the FEV1 results before and after administration of the product shall be analyzed using a paired t-test.

Time frame: Week 0, Week 24

Change in Forced Vital Capacity (FVC) before and after ARNUITY administration

The physicians shall collect FVC data at Week 0 and Week 24 after Arnuity administration. The change in the FVC results before and after administration of the product shall be analyzed using a paired t-test.

Time frame: Week 0, Week 24

Change in FEV1/FVC ratio before and after ARNUITY administration

The physicians shall collect FEV1/FVC data at Week 0 and Week 24 after Arnuity administration. The change in the FEV1/ FVC ratio before and after administration of the product shall be analyzed using a paired t-test

Time frame: Week 0, Week 24

Changes in the asthma symptom control results before and after ARNUITY administration

The physician shall collect the asthma symptom control results at Week 0 and Week 24 after Arnuity administration, based on the symptoms the subjects experienced for the past 4 weeks. The results of the asthma symptom control shall be categorized into 'Controlled', 'Partly Controlled', and 'Uncontrolled'.

Time frame: Week 0, Week 24