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

Study Overview
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Brief Summary
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This is an open-label, multi-center, PMS study to observe the safety and effectiveness of ARNUITY administered in asthma subjects in a real world setting. This PMS shall observe how a broad range of subjects use the drug in the early stages after obtaining the approval. The objective of this PMS is to collect safety and effectiveness data on ARNUITY's approved label in a real world setting. Total of 600 subjects shall be recruited throughout the PMS period; 01 Sep, 2018 to 30 June 2020. ARNUITY is the registered trademark of GSK group of companies.

Official Title
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An Open Label, Multi-centre, Post Marketing Surveillance to Observe the Safety and Effectiveness of ARNUITY Administered in Patients With Asthma in Usual Practice

Conditions
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Asthma

Intervention / Treatment
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* Drug: Arnuity


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Pediatric subjects older than 12 years of age and adult subjects with asthma Subjects who will administer ARNUITY in accordance with the product information approved in Korea Subjects who have signed the informed consent form for the PMS Exclusion Criteria: Subjects with status asthmaticus or subjects who have administered ARNUITY as primary therapy for other acute asthmatic episodes that require intensive treatment Subjects who have any known hyper-sensitivity to the drug or its ingredients Subjects who have severe hypersensitive reactions to milk proteins Subjects with hereditary problems of galactose intolerance, the Lapp lactase deficiency, or glucose-galactose malabsorption

Ages Eligible for Study
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Minimum Age: 12 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Subjects who received ARNUITY<br>This PMS will be conducted with subjects who were administered ARNUITY in accordance with the approved label. | Drug: Arnuity<br>* ARNUITY consist of Fluticasone Furoate, is an Inhaled corticosteroids (ICS) medicine taken as one inhalation, once daily, for the control and prevention of asthma in adults and children aged 12 years and older.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 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. | 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. | 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. | 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. | 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. | 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 | 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'. | Week 0, Week 24 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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ARNUITY, Effectiveness, Asthma, Post-marketing surveillance, Safety