Arnuity® Ellipta® Drug Use Investigation

Study Overview
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Brief Summary
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The aim of this post-marketing investigation is to collect and assess the information about safety and effectiveness of ARNUITY® ELLIPTA® (hereinafter referred to as Arnuity) in daily clinical practice. The investigation will include subjects with a diagnosis of asthma bronchial who are naïve to ARNUITY. The investigator will monitor the information about safety and effectiveness of ARNUITY for one year from the start date of ARNUITY administration and Pneumonia will be considered as the priority investigation matter. 300 subjects, from approximately 150 medical institutions, will be included in this analysis. ARNUITY ELLIPTA is the registered trademark of GlaxoSmithKline (GSK) group of companies.

Official Title
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Arnuity Ellipta Drug Use Investigation

Conditions
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Asthma

Intervention / Treatment
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* Drug: Arnuity Ellipta


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: The investigation will include subjects with a diagnosis of asthma bronchial, for which Arnuity is indicated and who are naïve to Arnuity. Exclusion Criteria: Not applicable
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 RECEIVING ARNUITY ELLIPTA<br>Subjects with a diagnosis of asthma bronchial, for which Arnuity is indicated, who are naïve to Arnuity will be included. | Drug: Arnuity Ellipta<br>* The active component of Arnuity Ellipta is fluticasone furoate and it is indicated for the treatment of bronchial asthma. Post-marketing investigation of ARNUITY ELLIPTA will be carried out in this analysis.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of subjects with adverse events (AEs), serious AEs (SAEs), severe AEs and drug related AEs | The investigator will collect the information about all AEs (e.g., a disease, symptom, abnormal laboratory value) occurring after the start of Arnuity administration, regardless of whether or not Arnuity is related to an AE. | One year from the start of Arnuity administration | 
| Number of subjects with pneumonia | Pneumonia will be considered as priority investigation matter for this investigation and its occurrence will be monitored throughout the study period. | One year from the start of Arnuity administration | 
| Response rate based on global assessment of effectiveness | The response rate is the proportion of subjects assessed as effective. Effectiveness will be comprehensively assessed based on the course of subjective and clinical symptoms and changes in Asthma Control Test (ACT) scores, etc. from the start date of administration to the end of the observation period. | One year from the start of Arnuity administration | 
| Total ACT score | ACT is a simple 5-question tool to evaluate the progression of asthma. Investigator will record the information from the ACT completed by subjects at the start of Arnuity administration, at Month 3, Year 1 from the start of Arnuity administration, or at the time of withdrawal from/termination of administration. | One year from the start of Arnuity administration | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Drug Use Investigation, GW685698, asthma, Post-marketing surveillance, ARNUITY ELLIPTA